Skip to content
Drybench
FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: C

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with C, grouped by the NDA number the list gives.

FDA capture · review pending. Each row is shown as captured from FDA's list. Spreadsheet day numbers are shown as dates; a cell that cannot be read as one date is shown as written. A row is placed under an NDA only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads the list has not been independently reviewed by a regulatory-affairs reviewer.

Paragraph IV list captured
17 October 2026
Last checked
30 October 2026

Rows as FDA lists them, not a forecast of market entry and not legal, regulatory or investment advice.

FDA's list is not complete and names no ANDA applicant, patent number or litigation. A product not shown here may still have had a Paragraph IV certification submitted; a product shown under an NDA may have more rows among those kept apart.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Paragraph IV certificationWhat changed, by week

Cabazitaxel

NDA 201023 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 60 mg/1.5 mL

    RLD/NDA as listed: Jevtana Kit 201023
    First PIV submission
    17 Jun 2014
    ANDAs
    8
    180-day status
    Extinguished Eligible Deferred
    Decision posted
    1/20/2026 2/20/2023 7/25/2022
    First applicant approval
    23 Jun 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Dec 2025

Cabozantinib

NDA 208692 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 20 mg, 40 mg and 60 mg

    RLD/NDA as listed: Cabometyx 208692
    First PIV submission
    16 Aug 2019
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    17 Aug 2026
    First applicant approval
    14 Aug 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Jul 2033

Calcipotriene

NDA 020554 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Cream · 0.005%

    RLD/NDA as listed: Dovonex 20554
    First PIV submission
    2 Dec 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    25 Feb 2020
    First applicant approval
    30 May 2012
    First marketing
    27 Jul 2012
    Last qualifying patent expiry (as listed by FDA)
    9 Jun 2015

Calcipotriene

NDA 020611 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Solution · 0.005%

    RLD/NDA as listed: Dovonex 20611
    First PIV submission
    19 May 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    25 Feb 2020
    First applicant approval
    6 May 2008
    First marketing
    6 May 2008
    Last qualifying patent expiry (as listed by FDA)
    9 Jun 2015

Calcipotriene and Betamethasone Dipropionate

NDA 021852 · 1 row · Listed patents and exclusivities · Open in the app

  • Ointment · 0.005%/0.064%

    RLD/NDA as listed: Taclonex 21852
    First PIV submission
    31 Mar 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    25 Feb 2020
    First applicant approval
    14 Jan 2013
    First marketing
    31 Mar 2014
    Last qualifying patent expiry (as listed by FDA)
    27 Jan 2020

Calcipotriene and Betamethasone Dipropionate

NDA 207589 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Foam · 0.005%/0.064%

    RLD/NDA as listed: Enstilar 207589
    First PIV submission
    22 Jun 2020
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Apr 2023
    First applicant approval
    21 Mar 2023
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2031

Calcitonin-Salmon

NDA 020313 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 200 IU/spray

    RLD/NDA as listed: Miacalcin 20313
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Calcitonin-Salmon (Recombinant)

NDA 021406 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 200 IU/spray

    RLD/NDA as listed: Fortical 21406
    First PIV submission
    29 Mar 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Feb 2021

Calcitriol

NDA 018874 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 1 mcg/mL and 2 mcg/mL, 1 mL vials

    RLD/NDA as listed: Calcijex 18874
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Calcium Acetate

NDA 021160 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · EQ 169 mg calcium

    RLD/NDA as listed: PhosLo 21160
    First PIV submission
    31 May 2005
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    25 Feb 2020
    First applicant approval
    26 Feb 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Apr 2021

Calcium Acetate

NDA 022581 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 667 mg/5 mL

    RLD/NDA as listed: Phoslyra 22581
    First PIV submission
    5 Dec 2013
    ANDAs
    2
    180-day status
    Extinguished
    Decision posted
    17 Mar 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 Feb 2030

Calcium Carbonate/ Famotadine/ Magnesium Hydroxide

NDA 020958 · 1 row · Listed patents and exclusivities · Open in the app

  • Chewable Tablets · 800 mg/10 mg/ 165 mg (OTC)

    RLD/NDA as listed: Pepcid Complete 20958
    First PIV submission
    1 Nov 2004
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    10 Mar 2020
    First applicant approval
    6 Feb 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Mar 2016

Calcium Gluconate in Sodium Chloride

NDA 208418 · 1 row · Listed patents and exclusivities · Open in the app

  • Intravenous · 1000 mg/50 mL 2000 mg/100 mL

    RLD/NDA as listed: Calcium Gluconate 208418
    First PIV submission
    26 Aug 2025
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    3 Aug 2026
    First applicant approval
    30 Dec 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Jul 2037

Calcium Oxybate, Magnesium Oxybate, Potassium Oxybate and Sodium Oxybate

NDA 212690 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 0.234 g/0.096 g/ 013 g/0.04 g per mL

    RLD/NDA as listed: Xywav 212690
    First PIV submission
    12 Apr 2021
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Mar 2033

Canagliflozin

NDA 204042 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg and 300 mg

    RLD/NDA as listed: Invokana 204042
    First PIV submission
    29 Mar 2017
    ANDAs
    10
    180-day status
    Deferred
    Decision posted
    27 Apr 2026
    First applicant approval
    14 Apr 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Feb 2029

Canagliflozin and Metformin Hydrochloride

NDA 204353 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg

    RLD/NDA as listed: Invokamet 204353
    First PIV submission
    29 Mar 2017
    ANDAs
    6
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Feb 2029

Canagliflozin and Metformin Hydrochloride

NDA 205879 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg

    RLD/NDA as listed: Invokamet-XR 205879
    First PIV submission
    21 Nov 2018
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Feb 2029

Candesartan Cilexetil

NDA 020838 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 4 mg, 8 mg, 16 mg and 32 mg

    RLD/NDA as listed: Atacand 20838
    First PIV submission
    22 Dec 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Mar 2020
    First applicant approval
    3 May 2013
    First marketing
    21 May 2013
    Last qualifying patent expiry (as listed by FDA)
    9 Jan 2014

Candesartan Cilexetil and Hydrochlorothiazide

NDA 021093 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 16 mg/12.5 mg and 32 mg/12.5 mg

    RLD/NDA as listed: Atacand HCT 21093
    First PIV submission
    25 Jun 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    4 Dec 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Feb 2015

  • Tablets · 32 mg/25 mg

    RLD/NDA as listed: Atacand HCT 21093
    First PIV submission
    6 Mar 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Mar 2020
    First applicant approval
    4 Dec 2012
    First marketing
    4 Dec 2012
    Last qualifying patent expiry (as listed by FDA)
    24 Feb 2015

Cangrelor

NDA 204958 · 1 row · Listed patents and exclusivities · Open in the app

  • For Injection · 50 mg/vial

    RLD/NDA as listed: Kengreal 204958
    First PIV submission
    24 Jun 2019
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    29 Sep 2025
    First applicant approval
    11 Aug 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jul 2035

Cannabidiol

NDA 210365 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 100 mg/mL

    RLD/NDA as listed: Epidiolex 210365
    First PIV submission
    28 Sep 2022
    ANDAs
    10
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Mar 2041

Capecitabine

NDA 020896 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 150 mg and 500 mg

    RLD/NDA as listed: Xeloda 20896
    First PIV submission
    10 Nov 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    8 Aug 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Dec 2013

Capmatinib

NDA 213591 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 150 mg and 200 mg

    RLD/NDA as listed: Tabrecta 213591
    First PIV submission
    6 May 2024
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2035

Captopril

NDA 018343 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 12.5 mg, 25 mg, 50 mg, and 100 mg

    RLD/NDA as listed: Capoten 18343
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Carbamazepine

NDA 020234 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 100 mg

    RLD/NDA as listed: Tegretol-XR 20234
    First PIV submission
    30 Dec 2005
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    10 Mar 2020
    First applicant approval
    31 Mar 2009
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Feb 2011

  • Extended-release Tablets · 200 mg and 400 mg

    RLD/NDA as listed: Tegretol-XR 20234
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Carbamazepine

NDA 020712 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 100 mg and 200 mg

    RLD/NDA as listed: Carbatrol 20712
    First PIV submission
    2 Feb 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Jun 2016

  • Extended-release Capsules · 300 mg

    RLD/NDA as listed: Carbatrol 20712
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Carbamazepine

NDA 021710 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 100 mg

    RLD/NDA as listed: Equetro 21710
    First PIV submission
    23 May 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 May 2024

  • Extended-release Capsules · 200 mg and 300 mg

    RLD/NDA as listed: Equetro 21710
    First PIV submission
    21 Aug 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 May 2024

Carbidopa and Levodopa

NDA 019856 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 25 mg/100 mg and 50 mg/200 mg

    RLD/NDA as listed: Sinemet CR 19856
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Carbidopa and Levodopa

NDA 203312 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg

    RLD/NDA as listed: Rytary 203312
    First PIV submission
    24 Jun 2015
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    10 Aug 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Dec 2028

  • Extended-release Capsules · 61.25 mg/245 mg

    RLD/NDA as listed: Rytary 203312
    First PIV submission
    10 Jun 2015
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    10 Aug 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Dec 2028

Carbidopa and Levodopa

NDA 217186 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 35 mg/140 mg 52.5 mg/210 mg 70 mg/280 mg 87.5 mg/350 mg

    RLD/NDA as listed: Crextont 217186
    First PIV submission
    23 Sep 2024
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Dec 2041

Carbidopa, Levodopa and Entacapone

NDA 021485 · 4 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 12.5 mg, 50 mg and 200 mg

    RLD/NDA as listed: Stalevo 50 21485
    First PIV submission
    5 Aug 2008
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    3/10/2020 3/10/2020
    First applicant approval
    20 Nov 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Jun 2020

  • Tablets · 18.75 mg/75 mg/ 200 mg and 31.25 mg/125 mg/ 200 mg

    RLD/NDA as listed: Stalevo 75 and Stalevo 125 21485
    First PIV submission
    19 May 2009
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    10 Mar 2020
    First applicant approval
    20 Nov 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Jun 2020

  • Tablets · 25/100/200 mg and 37.5/150/200 mg

    RLD/NDA as listed: Stalevo 100 and Stalevo 150 21485
    First PIV submission
    29 Jun 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    10 May 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Jun 2020

  • Tablets · 50 mg/200 mg/ 200 mg

    RLD/NDA as listed: Stalevo 200 21485
    First PIV submission
    28 Aug 2008
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Carboplatin

NDA 019880 · 1 row · Listed patents and exclusivities · Open in the app

  • For Injection · 50 mg/vial, 150 mg/vial and 450 mg/vial

    RLD/NDA as listed: Paraplatin 19880
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Carboplatin

NDA 020452 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 50 mg/vial, 150 mg/vial and 450 mg/vial

    RLD/NDA as listed: Paraplatin 20452
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Carfilzomib

NDA 202714 · 3 rows · Listed patents and exclusivities · Open in the app

  • For Injection · 10 mg/vial

    RLD/NDA as listed: Kyprolis 202714
    First PIV submission
    28 Nov 2018
    ANDAs
    1
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    8/3/2026 7/13/2021
    First applicant approval
    11 Jun 2021
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Feb 2033

  • For Injection · 30 mg/vial

    RLD/NDA as listed: Kyprolis 202714
    First PIV submission
    5 Oct 2017
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    25 Jul 2022
    First applicant approval
    20 Mar 2020
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Feb 2033

  • For Injection · 60 mg/vial

    RLD/NDA as listed: Kyprolis 202714
    First PIV submission
    20 Jul 2016
    ANDAs
    9
    180-day status
    Eligible
    Decision posted
    13 Jul 2021
    First applicant approval
    9 Sep 2019
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Dec 2027

Cariprazine

NDA 204370 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 1.5 mg, 3 mg, 4.5 mg and 6 mg

    RLD/NDA as listed: Vraylar 204370
    First PIV submission
    17 Sep 2019
    ANDAs
    3
    180-day status
    Eligible
    Decision posted
    4 Oct 2022
    First applicant approval
    9 Sep 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Jul 2029

Carisoprodol/ Aspirin

NDA 012365 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 200 mg/ 325 mg

    RLD/NDA as listed: Soma Compound 12365
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Carisoprodol/ Aspirin/ Codeine

NDA 012366 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 200 mg/325 mg/ 16 mg

    RLD/NDA as listed: Soma Compound with Codeine 12366
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Carvedilol

NDA 020297 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 3.125 mg, 6.25 mg, 12.5 mg and 25 mg

    RLD/NDA as listed: Coreg 20297
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Carvedilol Phosphate

NDA 022012 · 3 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 10 mg and 20 mg

    RLD/NDA as listed: Coreg CR 22012
    First PIV submission
    18 Mar 2008
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    25 Oct 2017
    First marketing
    8 Nov 2017
    Last qualifying patent expiry (as listed by FDA)
    27 Dec 2023

  • Extended-release Capsules · 40 mg

    RLD/NDA as listed: Coreg CR 22012
    First PIV submission
    21 Dec 2007
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    25 Oct 2017
    First marketing
    8 Nov 2017
    Last qualifying patent expiry (as listed by FDA)
    27 Dec 2023

  • Extended-release Capsules · 80 mg

    RLD/NDA as listed: Coreg CR 22012
    First PIV submission
    19 Nov 2007
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    25 Oct 2017
    First marketing
    8 Nov 2017
    Last qualifying patent expiry (as listed by FDA)
    27 Dec 2023

Caspofungin Acetate

NDA 021227 · 1 row · Listed patents and exclusivities · Open in the app

  • for Injection · 50 mg/vial and 70 mg/vial

    RLD/NDA as listed: Cancidas 21227
    First PIV submission
    26 Jun 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Mar 2017

Cefixime

NDA 202091 · 1 row · Listed patents and exclusivities · Open in the app

  • for Oral Suspension · 500 mg/5 mL

    RLD/NDA as listed: Suprax 202091
    First PIV submission
    22 Jul 2016
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    6 Feb 2017
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Dec 2028

Ceftaroline Fosamil

NDA 200327 · 1 row · Listed patents and exclusivities · Open in the app

  • for Injection · 400 mg/vial and 600 mg/vial

    RLD/NDA as listed: Teflaro 200327
    First PIV submission
    29 Oct 2014
    ANDAs
    2
    180-day status
    Deferred
    Decision posted
    19 Oct 2021
    First applicant approval
    21 Sep 2021
    First marketing
    12 Feb 2026
    Last qualifying patent expiry (as listed by FDA)
    10 Feb 2031

Celecoxib

NDA 020998 · 2 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 100 mg, 200 mg and 400 mg

    RLD/NDA as listed: Celebrex 20998
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

  • Capsules · 50 mg

    RLD/NDA as listed: Celebrex 20998
    First PIV submission
    21 Mar 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    30 May 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Apr 2018

Cenobamate

NDA 212839 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg

    RLD/NDA as listed: Xcopri 212839
    First PIV submission
    11 Mar 2024
    ANDAs
    2
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Jun 2039

Cetirizine Hydrochloride

NDA 020346 · 1 row · Listed patents and exclusivities · Open in the app

  • Syrup · 5 mg/5 mL

    RLD/NDA as listed: Zyrtec 20346
    First PIV submission
    19 Mar 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    11 May 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Jun 2007

Cetirizine Hydrochloride

NDA 021621 · 1 row · Listed patents and exclusivities · Open in the app

  • Chewable Tablets · 5 mg and 10 mg

    RLD/NDA as listed: Zyrtec 21621
    First PIV submission
    25 Mar 2005
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Cetirizine Hydrochloride

NDA 208694 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 2.3999999999999998E-3

    RLD/NDA as listed: Zerviate 208694
    First PIV submission
    22 Jul 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Jul 2032

Cetirizine Hydrochloride and Pseudoephedrine

NDA 021150 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 5 mg/120 mg

    RLD/NDA as listed: Zyrtec-D 21150
    First PIV submission
    2 Jun 2004
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    25 Feb 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Jul 2019

Cevimeline Hydrochloride

NDA 020989 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 30 mg

    RLD/NDA as listed: Evoxac 20989
    First PIV submission
    27 Feb 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jul 2013

Chlorhexidine Gluconate

NDA 018423 · 1 row · Listed patents and exclusivities · Open in the app

  • Scrub brush/sponge · 4%

    RLD/NDA as listed: Hibiclens 18423
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Chlorpheniramine Polistirex and Hydrocodone Polistirex

NDA 019111 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 8 mg/10 mg and 4 mg/5 mg

    RLD/NDA as listed: Tussionex 19111
    First PIV submission
    10 Sep 2004
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    4 Oct 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Aug 2005

Ciclesonide

NDA 022004 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 50 mcg

    RLD/NDA as listed: Omnaris 22004
    First PIV submission
    13 Feb 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    22 Feb 2021
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Oct 2020

Ciclopirox

NDA 020519 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 0.77%

    RLD/NDA as listed: Loprox 20519
    First PIV submission
    10 May 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    7 Jan 2009
    First marketing
    3 Dec 2007
    Last qualifying patent expiry (as listed by FDA)
    5 Sep 2018

Cinacalcet Hydrochloride

NDA 021688 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 30 mg, 60 mg and 90 mg

    RLD/NDA as listed: Sensipar 21688
    First PIV submission
    10 Mar 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    27 Aug 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Dec 2016

Ciprofloxacin

NDA 020780 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 250 mg/5 mL and 500 mg/ 5 mL

    RLD/NDA as listed: Cipro 20780
    First PIV submission
    16 Oct 2009
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    5 Mar 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Dec 2014

Ciprofloxacin and Dexamethasone

NDA 021537 · 1 row · Listed patents and exclusivities · Open in the app

  • Otic Suspension · 0.3%/0.1%

    RLD/NDA as listed: Ciprodex 21537
    First PIV submission
    31 Jul 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    17 Nov 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Aug 2020

Ciprofloxacin Hydrochloride

NDA 019537 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg, 250 mg, 500 mg and 750 mg

    RLD/NDA as listed: Cipro 19537
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Cisatracurium Besylate (multi-dose)

NDA 020551 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 2 mg/mL, 10 mL vial

    RLD/NDA as listed: Nimbex 20551
    First PIV submission
    12 Aug 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    3 Feb 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Sep 2012

  • Cisatracurium Besylate (preserve free) · Injection · 2 mg/mL, 5 mL vial and 10 mg/mL, 20 mL vial

    RLD/NDA as listed: Nimbex 20551
    First PIV submission
    4 Aug 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    3 Feb 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Sep 2012

Cisplatin

NDA 018057 · 2 rows · Listed patents and exclusivities · Open in the app

  • For Injection · 10 mg/vial and 50 mg/vial

    RLD/NDA as listed: Platinol 18057
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

  • Injection · 1 mg/mL, 10 mL, 50 mL, 100 mL and 200 mL vials

    RLD/NDA as listed: Platinol-AQ 18057
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Cladribine

NDA 022561 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg

    RLD/NDA as listed: Mavenclad 22561
    First PIV submission
    7 Apr 2022
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Dec 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Oct 2026

Clarithromycin

NDA 050775 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 500 mg

    RLD/NDA as listed: Biaxin XL 50775
    First PIV submission
    PIV received prior to 2/5/2009
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Clascoterone

NDA 213433 · 1 row · Listed patents and exclusivities · Open in the app

  • Cream · 0.01

    RLD/NDA as listed: Winlevi 213433
    First PIV submission
    26 Aug 2024
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Jul 2030

Clevidipine

NDA 022156 · 1 row · Listed patents and exclusivities · Open in the app

  • Injectable Emulsion · 25 mg/50 mL and 50 mg/100 mL

    RLD/NDA as listed: Cleviprex 22156
    First PIV submission
    2 Jul 2019
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Oct 2031

Clindamycin Phosphate

NDA 050793 · 1 row · Listed patents and exclusivities · Open in the app

  • Vaginal Cream · 0.02

    RLD/NDA as listed: Clindesse 50793
    First PIV submission
    5 Feb 2015
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Apr 2023

Clindamycin Phosphate

NDA 050801 · 1 row · Listed patents and exclusivities · Open in the app

  • Foam · 1%

    RLD/NDA as listed: Evoclin 50801
    First PIV submission
    PIV received prior to 2/5/2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Mar 2020
    First applicant approval
    31 Mar 2010
    First marketing
    31 Mar 2010
    Last qualifying patent expiry (as listed by FDA)
    9 Aug 2026

Clindamycin Phosphate and Benzoyl Peroxide

NDA 050741 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 1% / 5%

    RLD/NDA as listed: Duac 50741
    First PIV submission
    11 Dec 2008
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    18 Jun 2019
    First applicant approval
    26 Jun 2012
    First marketing
    26 Jun 2012
    Last qualifying patent expiry (as listed by FDA)
    14 Nov 2012

Clindamycin Phosphate and Benzoyl Peroxide

NDA 050819 · 2 rows · Listed patents and exclusivities · Open in the app

  • Gel · 1.2%/2.5%

    RLD/NDA as listed: Acanya 50819
    First PIV submission
    20 Dec 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    19 Jun 2015
    First marketing
    19 Feb 2019
    Last qualifying patent expiry (as listed by FDA)
    5 Aug 2029

  • Gel · 1.2%/3.75%

    RLD/NDA as listed: Onexton 50819
    First PIV submission
    30 Sep 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    5 Jun 2018
    First marketing
    2 Oct 2023
    Last qualifying patent expiry (as listed by FDA)
    5 Aug 2029

Clindamycin Phosphate and Tretinoin

NDA 050802 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 1.2%/0.025%

    RLD/NDA as listed: Ziana 50802
    First PIV submission
    17 Dec 2010
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    18 Jun 2019
    First applicant approval
    12 Jun 2015
    First marketing
    5 Jul 2016
    Last qualifying patent expiry (as listed by FDA)
    3 Aug 2020

Clobetasol Propionate

NDA 021142 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Foam · 0.05%

    RLD/NDA as listed: Olux 21142
    First PIV submission
    27 Jun 2005
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    10 Mar 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Oct 2017

Clobetasol Propionate

NDA 021535 · 1 row · Listed patents and exclusivities · Open in the app

  • Lotion · 0.05%

    RLD/NDA as listed: Clobex 21535
    First PIV submission
    27 Mar 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    4 Dec 2008
    First marketing
    2 Jan 2012
    Last qualifying patent expiry (as listed by FDA)
    22 Sep 2017

Clobetasol Propionate

NDA 021644 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Shampoo · 0.05%

    RLD/NDA as listed: Clobex 21644
    First PIV submission
    9 Jan 2008
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    7 Apr 2020
    First applicant approval
    7 Jun 2011
    First marketing
    2 Jan 2012
    Last qualifying patent expiry (as listed by FDA)
    17 Jun 2019

Clobetasol Propionate

NDA 021835 · 1 row · Listed patents and exclusivities · Open in the app

  • Spray · 0.05%

    RLD/NDA as listed: Clobex 21835
    First PIV submission
    29 Sep 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    16 Jun 2011
    First marketing
    1 Jan 2015
    Last qualifying patent expiry (as listed by FDA)
    24 Mar 2018

Clobetasol Propionate

NDA 022013 · 1 row · Listed patents and exclusivities · Open in the app

  • Emulsion Foam · 5.0000000000000001E-4

    RLD/NDA as listed: Olux-E 22013
    First PIV submission
    25 Feb 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    14 Aug 2012
    First marketing
    1 Feb 2013
    Last qualifying patent expiry (as listed by FDA)
    8 Sep 2019

Clobetasol Propionate

NDA 209483 · 1 row · Listed patents and exclusivities · Open in the app

  • Cream · 2.5000000000000001E-4

    RLD/NDA as listed: Impoyz 209483
    First PIV submission
    6 Dec 2019
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Mar 2035

Clofarabine

NDA 021673 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 1 mg/mL, 20 mL vial

    RLD/NDA as listed: Clolar 21673
    First PIV submission
    23 Feb 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    9 May 2017
    First marketing
    9 May 2017
    Last qualifying patent expiry (as listed by FDA)
    14 Jan 2018

Clonidine Hydrochloride

NDA 018891 · 1 row · Listed patents and exclusivities · Open in the app

  • Transdermal System · 0.1 mg/day 0.2 mg/day 0.3 mg/day

    RLD/NDA as listed: Catapres-TTS 18891
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Clonidine Hydrochloride

NDA 022331 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 0.1 mg and 0.2 mg

    RLD/NDA as listed: Jenloga 22331
    First PIV submission
    4 Mar 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    2 Apr 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Oct 2013

  • Extended-release Tablets · 0.1 mg and 0.2 mg

    RLD/NDA as listed: Kapvay 22331
    First PIV submission
    4 Mar 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    30 Sep 2013
    First marketing
    7 Oct 2013
    Last qualifying patent expiry (as listed by FDA)
    13 Oct 2013

Clopidogrel Bisulfate

NDA 020839 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 300 mg

    RLD/NDA as listed: Plavix 20839
    First PIV submission
    4 Mar 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    17 May 2012
    First marketing
    17 May 2012
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2019

  • Tablets · 75 mg

    RLD/NDA as listed: Plavix 20839
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Clozapine

NDA 021590 · 4 rows · Listed patents and exclusivities · Open in the app

  • Orally Disintegrating Tablets · 12.5 mg

    RLD/NDA as listed: Fazaclo 21590
    First PIV submission
    5 Jun 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Apr 2018

  • Orally Disintegrating Tablets · 150 mg

    RLD/NDA as listed: Fazaclo 21590
    First PIV submission
    8 Apr 2011
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    25 Nov 2015
    First marketing
    4 May 2015
    Last qualifying patent expiry (as listed by FDA)
    9 Apr 2018

  • Orally Disintegrating Tablets · 200 mg

    RLD/NDA as listed: Fazaclo 21590
    First PIV submission
    18 Apr 2011
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    25 Nov 2015
    First marketing
    4 May 2015
    Last qualifying patent expiry (as listed by FDA)
    9 Apr 2018

  • Orally Disintegrating Tablets · 25 mg and 100 mg

    RLD/NDA as listed: Fazaclo 21590
    First PIV submission
    28 Apr 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    25 Nov 2015
    First marketing
    30 Aug 2012
    Last qualifying patent expiry (as listed by FDA)
    9 Apr 2018

Cobicistat

NDA 203094 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 150 mg

    RLD/NDA as listed: Tybost 203094
    First PIV submission
    14 Nov 2016
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    4 Mar 2024
    First applicant approval
    7 Feb 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Sep 2029

Colchicine

NDA 022352 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 0.3 mg

    RLD/NDA as listed: Colcrys 22352
    First PIV submission
    19 Jul 2019
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    14 Nov 2019
    First marketing
    1 Aug 2020
    Last qualifying patent expiry (as listed by FDA)
    17 Feb 2029

  • Tablets · 0.6 mg

    RLD/NDA as listed: Colcrys 22352
    First PIV submission
    23 Dec 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    2 Jul 2018
    Last qualifying patent expiry (as listed by FDA)
    17 Feb 2029

Colchicine

NDA 204820 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 0.6 mg

    RLD/NDA as listed: Mitigare 204820
    First PIV submission
    10 Jun 2016
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Aug 2019
    First applicant approval
    29 Nov 2018
    First marketing
    1 Nov 2023
    Last qualifying patent expiry (as listed by FDA)
    22 Aug 2033

Colchicine

NDA 210942 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 0.6 mg/5 mL

    RLD/NDA as listed: Gloperba 210942
    First PIV submission
    2 Apr 2020
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    10 Jan 2023
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Dec 2037

Colesevelam Hydrochloride

NDA 021176 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 625 mg

    RLD/NDA as listed: Welchol 21176
    First PIV submission
    1 Jul 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    16 May 2018
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Dec 2014

Colesevelam Hydrochloride

NDA 022362 · 1 row · Listed patents and exclusivities · Open in the app

  • Powder for Oral Suspension · 1.875 g/Packet and 3.75 g/Packet

    RLD/NDA as listed: Welchol 22362
    First PIV submission
    9 Apr 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Dec 2014

Conjugated Estrogen (Synthetic A)

NDA 020992 · 3 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 0.3 mg, 0.45 mg and 0.9 mg

    RLD/NDA as listed: Cenestin 20992
    First PIV submission
    19 Mar 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Jul 2015

  • Tablets · 0.625 mg

    RLD/NDA as listed: Cenestin 20992
    First PIV submission
    2 Mar 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Jul 2015

  • Tablets · 1.25 mg

    RLD/NDA as listed: Cenestin 20992
    First PIV submission
    3 Nov 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Jul 2015

Conjugated Estrogens

NDA 004782 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 0.3 mg and 0.625 mg

    RLD/NDA as listed: Premarin 04782
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Crisaborole

NDA 207695 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Ointment · 0.02

    RLD/NDA as listed: Eucrisa 207695
    First PIV submission
    14 Jun 2021
    ANDAs
    5
    180-day status
    Deferred
    Decision posted
    28 Sep 2026
    First applicant approval
    24 Sep 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Jan 2030

Cupric Sulfate, Magnesium Sulfate, Selenious Acid, Zinc Sulfate

NDA 209376 · 3 rows · Listed patents and exclusivities · Open in the app

  • Injection · 0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (1 mL)

    RLD/NDA as listed: Tralement 209376
    First PIV submission
    14 Nov 2023
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Jul 2041

  • Injection · 0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL)

    RLD/NDA as listed: Tralement 209376
    First PIV submission
    14 Nov 2023
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Jul 2041

  • Injection · 60 mcg/mL, 3 mcg/mL, 6 mcg/mL, 1000 mcg/mL

    RLD/NDA as listed: Multrys 209376
    First PIV submission
    14 Nov 2023
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Jul 2041

Cyanocobalamin

NDA 021642 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 500 mcg/spray

    RLD/NDA as listed: Nascobal 21642
    First PIV submission
    28 Apr 2017
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    6 Apr 2021
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Aug 2024

Cyclobenzaprine Hydrochloride

NDA 219428 · 1 row · Listed patents and exclusivities · Open in the app

  • Sublingual Tablets · 2.8 mg

    RLD/NDA as listed: Tonmya 219428
    First PIV submission
    29 Jul 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Mar 2034

Cyclobenzaprine Hydrochloride

NDA 017821 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg

    RLD/NDA as listed: Flexeril 17821
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Cyclobenzaprine Hydrochloride

NDA 021777 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsule · 15 mg and 30 mg

    RLD/NDA as listed: Amrix 21777
    First PIV submission
    11 Aug 2008
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture
    Decision posted
    4/7/2020 4/7/2020
    First applicant approval
    blank
    First marketing
    13 May 2011
    Last qualifying patent expiry (as listed by FDA)
    26 Feb 2025

Cyclophosphamide

NDA 012142 · 1 row · Listed patents and exclusivities · Open in the app

  • For Injection · 100 mg/vial 200 mg/vial 500 mg/vial 1 g/vial 2 g/vial

    RLD/NDA as listed: Cytoxan 12142
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Cyclophosphamide

NDA 212501 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 2 g/10 mL

    RLD/NDA as listed: Cyclophos 212501
    First PIV submission
    17 Jan 2023
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    27 Apr 2026
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Feb 2036

  • Injection · 500 mg/2.5 mL and 1 g/5 mL

    RLD/NDA as listed: Cyclophos 212501
    First PIV submission
    7 Mar 2022
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Nov 2024
    First applicant approval
    29 Oct 2024
    First marketing
    29 Oct 2024
    Last qualifying patent expiry (as listed by FDA)
    15 Feb 2036

Cyclosporine

NDA 050790 · 2 rows · Listed patents and exclusivities · Open in the app

  • Ophthalmic Emulsion · 5.0000000000000001E-4

    RLD/NDA as listed: Restasis 50790
    First PIV submission
    13 Jan 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    17 May 2014

  • Ophthalmic Emulsion · 5.0000000000000001E-4

    RLD/NDA as listed: Restasis Multidose 50790
    First PIV submission
    29 Jan 2020
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 May 2034

Cysteamine Bitartrate

NDA 203389 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 25 mg and 75 mg

    RLD/NDA as listed: Procysbi 203389
    First PIV submission
    11 May 2020
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    17 Mar 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Aug 2036

Cysteamine Bitartrate

NDA 213491 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Granules · 75 mg/Packet and 300 mg/Packet

    RLD/NDA as listed: Procysbi 213491
    First PIV submission
    16 Dec 2021
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Aug 2036

Cysteine Hydrochloride

NDA 210660 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 500 mg/10 mL

    RLD/NDA as listed: Elcys 210660
    First PIV submission
    10 Dec 2019
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Jan 2039