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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: M

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with M, 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

Macitentan

NDA 204410 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg

    RLD/NDA as listed: Opsumit 204410
    First PIV submission
    18 Oct 2017
    ANDAs
    11
    180-day status
    Eligible
    Decision posted
    4 May 2021
    First applicant approval
    6 Apr 2021
    First marketing
    6 Jun 2026
    Last qualifying patent expiry (as listed by FDA)
    18 Apr 2029

Malathion

NDA 018613 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Lotion · 5.0000000000000001E-3

    RLD/NDA as listed: Ovide 18613
    First PIV submission
    16 Mar 2011
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Feb 2022
    First applicant approval
    23 May 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Feb 2027

Maralixibat Chloride

NDA 214662 · 2 rows · Listed patents and exclusivities · Open in the app

  • Oral Solution · 19 mg/mL

    RLD/NDA as listed: Livmarli 214662
    First PIV submission
    29 Sep 2025
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Feb 2040

  • Oral Solution · 9.5 mg/mL

    RLD/NDA as listed: Livmarli 214662
    First PIV submission
    29 Sep 2025
    ANDAs
    4
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Feb 2040

Maralixibat Chloride

NDA 219485 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg, 15 mg, 20 mg and 30 mg

    RLD/NDA as listed: Livmarli 219485
    First PIV submission
    18 Jun 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)
    5 Oct 2043

Maraviroc

NDA 022128 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 150 mg and 300 mg

    RLD/NDA as listed: Selzentry 22128
    First PIV submission
    8 Aug 2011
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    22 Feb 2022
    First applicant approval
    7 Feb 2022
    First marketing
    7 Feb 2022
    Last qualifying patent expiry (as listed by FDA)
    25 Nov 2022

Maribavir

NDA 215596 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 200 mg

    RLD/NDA as listed: Livtencity 215596
    First PIV submission
    24 Nov 2025
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Oct 2043

Mavacamten

NDA 214998 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 2.5 mg, 5 mg, 10 mg and 15 mg

    RLD/NDA as listed: Camzyos 214998
    First PIV submission
    28 Apr 2026
    ANDAs
    7
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Apr 2036

Mefloquine Hydrochloride

NDA 019591 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 250 mg

    RLD/NDA as listed: Lariam 19591
    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

Megestrol Acetate

NDA 020264 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 40 mg/mL

    RLD/NDA as listed: Megace 20264
    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

Megestrol Acetate

NDA 021778 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 125 mg/mL

    RLD/NDA as listed: Megace ES 21778
    First PIV submission
    27 Apr 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    5 Oct 2021
    First applicant approval
    27 Aug 2014
    First marketing
    1 Jul 2015
    Last qualifying patent expiry (as listed by FDA)
    22 Apr 2024

Meloxicam

NDA 021530 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 7.5 mg/5 mL

    RLD/NDA as listed: Mobic 21530
    First PIV submission
    17 Dec 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)
    25 Sep 2019

Meloxicam

NDA 207233 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 5 mg and 10 mg

    RLD/NDA as listed: Vivlodex 207233
    First PIV submission
    9 Jan 2017
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    3/9/2021 6/29/2020
    First applicant approval
    1 Jun 2020
    First marketing
    22 Dec 2020
    Last qualifying patent expiry (as listed by FDA)
    31 Mar 2033

Meloxicam

NDA 211210 · 1 row · Listed patents and exclusivities · Open in the app

  • Orally Disintegrating Tablets · 7.5 mg and 15 mg

    RLD/NDA as listed: Qmiiz ODT 211210
    First PIV submission
    20 Apr 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)
    31 Aug 2030

Meloxicam and Rizatriptan Benzoate

NDA 215431 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 20 mg/10 mg

    RLD/NDA as listed: Symbravo 215431
    First PIV submission
    30 Jun 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 May 2040

Melphalan Hydrochloride

NDA 207155 · 1 row · Listed patents and exclusivities · Open in the app

  • Powder for Injection · 50 mg/vial

    RLD/NDA as listed: Evomela 207155
    First PIV submission
    8 Sep 2017
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    19 May 2020
    First applicant approval
    6 Mar 2020
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Feb 2033

Memantine Hydrochloride

NDA 021487 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg and 10 mg

    RLD/NDA as listed: Namenda 21487
    First PIV submission
    16 Oct 2007
    ANDAs
    14
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    30 Jan 2015
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Apr 2015

Memantine Hydrochloride

NDA 022525 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 7 mg, 14 mg, 21 mg, and 28 mg

    RLD/NDA as listed: Namenda XR 22525
    First PIV submission
    10 Jun 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    12 Oct 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Memantine Hydrochloride Extended-release and Donepezil Hydrochloride

NDA 206439 · 3 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 14 mg/10 mg and 28 mg/10 mg

    RLD/NDA as listed: Namzaric 206439
    First PIV submission
    18 May 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    9 Feb 2021
    First applicant approval
    27 Jan 2017
    First marketing
    16 Jan 2025
    Last qualifying patent expiry (as listed by FDA)
    5 Dec 2029

  • Capsules · 21 mg/10 mg

    RLD/NDA as listed: Namzaric 206439
    First PIV submission
    23 Sep 2016
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    3/3/2025 1/8/2024
    First applicant approval
    15 Dec 2023
    First marketing
    1 Jan 2025
    Last qualifying patent expiry (as listed by FDA)
    5 Dec 2029

  • Capsules · 7 mg/10 mg

    RLD/NDA as listed: Namzaric 206439
    First PIV submission
    26 Sep 2016
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    9 Feb 2021
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    5 Dec 2029

Mesalamine

NDA 019651 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 400 mg

    RLD/NDA as listed: Asacol 19651
    First PIV submission
    22 Jun 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Jul 2013

Mesalamine

NDA 021252 · 1 row · Listed patents and exclusivities · Open in the app

  • Suppository · 1000 mg

    RLD/NDA as listed: Canasa 21252
    First PIV submission
    24 May 2013
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Aug 2019
    First applicant approval
    24 Nov 2015
    First marketing
    24 Nov 2015
    Last qualifying patent expiry (as listed by FDA)
    6 Jun 2028

Mesalamine

NDA 021830 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 800 mg

    RLD/NDA as listed: Asacol HD 21830
    First PIV submission
    13 Jul 2011
    ANDAs
    1
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    11/8/2024 2/11/2020
    First applicant approval
    21 Jul 2017
    First marketing
    1 Aug 2016
    Last qualifying patent expiry (as listed by FDA)
    15 Nov 2021

Mesalamine

NDA 022000 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 1.2 g

    RLD/NDA as listed: Lialda 22000
    First PIV submission
    16 Dec 2009
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    11 Feb 2020
    First applicant approval
    5 Jun 2017
    First marketing
    18 Jul 2017
    Last qualifying patent expiry (as listed by FDA)
    8 Jun 2020

Mesalamine

NDA 022301 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 0.375 g

    RLD/NDA as listed: Apriso 22301
    First PIV submission
    3 Apr 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Apr 2018

Mesalamine

NDA 204412 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 400 mg

    RLD/NDA as listed: Delzicol 204412
    First PIV submission
    17 Jun 2014
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture
    Decision posted
    6/18/2019 6/18/2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Apr 2020

Metaxalone

NDA 013217 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 400 mg

    RLD/NDA as listed: Skelaxin 13217
    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

  • Tablets · 800 mg

    RLD/NDA as listed: Skelaxin 13217
    First PIV submission
    4 Nov 2004
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    8 Sep 2020
    First applicant approval
    31 Mar 2010
    First marketing
    31 Mar 2010
    Last qualifying patent expiry (as listed by FDA)
    3 Dec 2021

Metformin Hydrochloride

NDA 021202 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 500 mg

    RLD/NDA as listed: Glucophage XR 21202
    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

  • Extended-release Tablets · 750 mg

    RLD/NDA as listed: Glucophage XR 21202
    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

Metformin Hydrochloride

NDA 021574 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 500 mg and 1000 mg

    RLD/NDA as listed: Fortamet 21574
    First PIV submission
    14 Oct 2008
    ANDAs
    1
    180-day status
    Extinguished Eligible
    Decision posted
    4/17/2023 2/8/2022
    First applicant approval
    29 Jun 2011
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    17 Mar 2021

Metformin Hydrochloride

NDA 021591 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 500 mg/5 mL

    RLD/NDA as listed: Riomet 21591
    First PIV submission
    2 Feb 2018
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Nov 2022
    First applicant approval
    3 Mar 2020
    First marketing
    20 Apr 2020
    Last qualifying patent expiry (as listed by FDA)
    7 Aug 2021

Metformin Hydrochloride

NDA 021748 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 500 mg and 1000 mg

    RLD/NDA as listed: Glumetza 21748
    First PIV submission
    27 Jul 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    16 Jul 2019
    First applicant approval
    19 Jul 2013
    First marketing
    1 Feb 2016
    Last qualifying patent expiry (as listed by FDA)
    500mg:10/25/2021 1 g: 6/20/2020

Methotrexate

NDA 205776 · 1 row · Listed patents and exclusivities · Open in the app

  • Subcutaneous Injection · 7.5 mg/0.15 mL 10 mg/0.2 mL 12.5 mg/0.25 mL 15 mg/0.3 mL 17.5 mg/0.35 mL 20 mg/0.4 mL 22.5 mg/0.45 mL 25 mg/0.5 mL 27.5 mg/0.55 mL 30 mg/0.6 mL

    RLD/NDA as listed: Rasuvo 205776
    First PIV submission
    4 May 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)
    1 Jun 2029

Methylnaltrexone Bromide

NDA 021964 · 3 rows · Listed patents and exclusivities · Open in the app

  • Injection · 12 mg/0.6 mL, Single Dose Prefilled Syringe

    RLD/NDA as listed: Relistor 21964
    First PIV submission
    8 Sep 2015
    ANDAs
    1
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    2/17/2025 8/26/2024
    First applicant approval
    26 Aug 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    31 Dec 2030

  • Injection · 12 mg/0.6 mL, Single Dose Vial

    RLD/NDA as listed: Relistor 21964
    First PIV submission
    22 Jul 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    9 Jun 2025
    First applicant approval
    28 May 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    31 Dec 2030

  • Injection · 8 mg/0.4 mL, Single Dose Prefilled Syringe

    RLD/NDA as listed: Relistor 21964
    First PIV submission
    8 Sep 2015
    ANDAs
    1
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    5/27/2025 8/26/2024
    First applicant approval
    26 Aug 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    31 Dec 2030

Methylnaltrexone Bromide

NDA 208271 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 150 mg

    RLD/NDA as listed: Relistor 208271
    First PIV submission
    6 Sep 2016
    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 Mar 2031

Methylphenidate

NDA 021514 · 1 row · Listed patents and exclusivities · Open in the app

  • Transdermal System · 10 mg/9 hrs 15 mg/9 hrs 20 mg/9 hrs 30 mg/9 hrs

    RLD/NDA as listed: Daytrana 21514
    First PIV submission
    13 Apr 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    9 Mar 2021
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Sep 2018

Methylphenidate

NDA 205489 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Orally Disintegrating Tablets · 8.6 mg, 17.3 mg and 25.9 mg

    RLD/NDA as listed: Cotempla XR-ODT 205489
    First PIV submission
    1 Sep 2017
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    13 Jul 2020
    First applicant approval
    19 Jun 2020
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Jun 2032

Methylphenidate Hydrochloride

NDA 021121 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 18 mg, 27 mg, 36 mg and 54 mg

    RLD/NDA as listed: Concerta 21121
    First PIV submission
    19 Jul 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

Methylphenidate Hydrochloride

NDA 021259 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 10 mg, 20 mg and 30 mg

    RLD/NDA as listed: Metadate CD 21259
    First PIV submission
    13 May 2005
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    8 Sep 2020
    First applicant approval
    19 Jul 2012
    First marketing
    27 Sep 2012
    Last qualifying patent expiry (as listed by FDA)
    27 Oct 2020

  • Extended-release Capsules · 40 mg

    RLD/NDA as listed: Metadate CD 21259
    First PIV submission
    15 Mar 2007
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    8 Sep 2020
    First applicant approval
    19 Jul 2012
    First marketing
    27 Sep 2012
    Last qualifying patent expiry (as listed by FDA)
    27 Oct 2020

Methylphenidate Hydrochloride

NDA 021284 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 10 mg

    RLD/NDA as listed: Ritalin LA 21284
    First PIV submission
    21 May 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)
    1 Nov 2019

  • Extended-release Capsules · 20 mg, 30 mg and 40 mg

    RLD/NDA as listed: Ritalin LA 21284
    First PIV submission
    21 Aug 2006
    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

Methylphenidate Hydrochloride

NDA 021419 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 5 mg/5 mL 10 mg/5 mL

    RLD/NDA as listed: Methylin 21419
    First PIV submission
    13 Apr 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    23 Jul 2010
    First marketing
    26 Jul 2010
    Last qualifying patent expiry (as listed by FDA)
    7 Oct 2024

Methylphenidate Hydrochloride

NDA 202100 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Oral Suspension · 5 mg/mL

    RLD/NDA as listed: Quillivant XR 202100
    First PIV submission
    2 Aug 2013
    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

Methylphenidate Hydrochloride

NDA 205831 · 4 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 10 mg

    RLD/NDA as listed: Aptensio XR 205831
    First PIV submission
    24 Dec 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    30 Jul 2019
    First applicant approval
    13 Dec 2018
    First marketing
    25 Sep 2020
    Last qualifying patent expiry (as listed by FDA)
    16 Dec 2019

  • Extended-release Capsules · 15 mg, 20 mg, 40 mg and 50 mg

    RLD/NDA as listed: Aptensio XR 205831
    First PIV submission
    28 Dec 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    30 Jul 2019
    First applicant approval
    13 Dec 2018
    First marketing
    25 Sep 2020
    Last qualifying patent expiry (as listed by FDA)
    16 Dec 2019

  • Extended-release Capsules · 30 mg

    RLD/NDA as listed: Aptensio XR 205831
    First PIV submission
    28 Mar 2016
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    30 Jul 2019
    First applicant approval
    13 Dec 2018
    First marketing
    25 Sep 2020
    Last qualifying patent expiry (as listed by FDA)
    16 Dec 2019

  • Extended-release Capsules · 60 mg

    RLD/NDA as listed: Aptensio XR 205831
    First PIV submission
    23 Dec 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    30 Jul 2019
    First applicant approval
    13 Dec 2018
    First marketing
    25 Sep 2020
    Last qualifying patent expiry (as listed by FDA)
    16 Dec 2019

Methylphenidate Hydrochloride

NDA 207960 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Chewable Tablets · 20 mg, 30 mg and 40 mg

    RLD/NDA as listed: Quillichew ER 207960
    First PIV submission
    25 Apr 2016
    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 Aug 2033

Metoclopramide Hydrochloride

NDA 017862 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 5 mg/mL, 2 mL, 10 mL, 20 mL and 30 mL vials

    RLD/NDA as listed: Reglan 17862
    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

Metoclopramide Hydrochloride

NDA 022246 · 1 row · Listed patents and exclusivities · Open in the app

  • Orally Disintegrating Tablets · 5 mg and 10 mg

    RLD/NDA as listed: Metozolv ODT 22246
    First PIV submission
    24 Aug 2010
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    4/18/2023 2/8/2022
    First applicant approval
    15 Aug 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Jul 2017

Metoclopramide Hydrochloride

NDA 209388 · 1 row · Listed patents and exclusivities · Open in the app

  • Metered Nasal Spray · 15 mg/spray

    RLD/NDA as listed: Gimoti 209388
    First PIV submission
    30 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 May 2030

Metoprolol Succinate

NDA 019962 · 1 row · Listed patents and exclusivities · Open in the app

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

    RLD/NDA as listed: Toprol XL 19962
    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

Metronidazole

NDA 020208 · 1 row · Listed patents and exclusivities · Open in the app

  • Vaginal Gel · 0.75%

    RLD/NDA as listed: MetroGel-Vaginal 20208
    First PIV submission
    2 Sep 2004
    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)
    6 Jun 2006

Metronidazole

NDA 021789 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Gel · 1%

    RLD/NDA as listed: Metrogel 21789
    First PIV submission
    21 Oct 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    4 May 2021
    First applicant approval
    22 Jul 2011
    First marketing
    1 Jul 2013
    Last qualifying patent expiry (as listed by FDA)
    21 Feb 2022

Metronidazole

NDA 205223 · 1 row · Listed patents and exclusivities · Open in the app

  • Vaginal Gel · 1.2999999999999999E-2

    RLD/NDA as listed: Nuvessa 205223
    First PIV submission
    30 Mar 2022
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Mar 2024
    First applicant approval
    18 Mar 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Jun 2032

Metronidazole

NDA 216755 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 500 mg/5 mL

    RLD/NDA as listed: Likmez 216755
    First PIV submission
    13 Nov 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Oct 2039

Micafungin Sodium

NDA 021506 · 1 row · Listed patents and exclusivities · Open in the app

  • For Injection · 50 mg/vial 100 mg/vial

    RLD/NDA as listed: Mycamine 21506
    First PIV submission
    16 Jun 2014
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    1 Jun 2020
    First applicant approval
    17 May 2019
    First marketing
    8 May 2020
    Last qualifying patent expiry (as listed by FDA)
    8 Jan 2021

Miconazole Nitrate

NDA 021308 · 1 row · Listed patents and exclusivities · Open in the app

  • Vaginal Cream and Suppository · 2% and 1.2 g

    RLD/NDA as listed: Monistat 1 Combination Pack 21308
    First PIV submission
    5 Dec 2007
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    4/18/2023 2/8/2022
    First applicant approval
    2 Jun 2010
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Nov 2020

Midazolam

NDA 211321 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 5 mg/spray

    RLD/NDA as listed: Nayzilam 211321
    First PIV submission
    1 Jun 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)
    18 Jan 2028

Midazolam

NDA 211844 · 1 row · Listed patents and exclusivities · Open in the app

  • Intravenous · 50 mg/50 mL and 100 mg/100 mL

    RLD/NDA as listed: Midazolam in 0.9% Sodium Chloride 211844
    First PIV submission
    29 Sep 2021
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Apr 2023
    First applicant approval
    17 Apr 2023
    First marketing
    6 Jul 2023
    Last qualifying patent expiry (as listed by FDA)
    20 Jun 2038

Midostaurin

NDA 207997 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 25 mg

    RLD/NDA as listed: Rydapt 207997
    First PIV submission
    28 Apr 2021
    ANDAs
    4
    180-day status
    Eligible
    Decision posted
    13 May 2024
    First applicant approval
    29 Apr 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Dec 2030

Mifepristone

NDA 202107 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 300 mg

    RLD/NDA as listed: Korlym 202107
    First PIV submission
    15 Dec 2017
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    3 Aug 2020
    First marketing
    19 Jan 2024
    Last qualifying patent expiry (as listed by FDA)
    15 Aug 2036

Migalastat Hydrochloride

NDA 208623 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 123 mg

    RLD/NDA as listed: Galafold 208623
    First PIV submission
    10 Aug 2022
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    6 Feb 2039

Milnacipran Hydrochloride

NDA 022256 · 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: Savella 22256
    First PIV submission
    14 Jan 2013
    ANDAs
    8
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    27 Jan 2016
    First marketing
    19 Mar 2026
    Last qualifying patent expiry (as listed by FDA)
    19 Sep 2029

Minocycline Hydrochloride

NDA 050444 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 100 mg/vial

    RLD/NDA as listed: Minocin 50444
    First PIV submission
    16 Oct 2020
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    28 Oct 2024
    First applicant approval
    24 Oct 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 May 2031

Minocycline Hydrochloride

NDA 050808 · 5 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablet · 105 mg

    RLD/NDA as listed: Solodyn 50808
    First PIV submission
    13 Dec 2010
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    8 Feb 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Feb 2018

  • Extended-release Tablet · 45 mg, 90 mg and 135 mg

    RLD/NDA as listed: Solodyn 50808
    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

  • Extended-release Tablet · 55 mg

    RLD/NDA as listed: Solodyn 50808
    First PIV submission
    2 Dec 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    13 Dec 2022
    First applicant approval
    30 Nov 2011
    First marketing
    22 Feb 2019
    Last qualifying patent expiry (as listed by FDA)
    20 Nov 2025

  • Extended-release Tablet · 65 mg and 115 mg

    RLD/NDA as listed: Solodyn 50808
    First PIV submission
    19 Nov 2009
    ANDAs
    1
    180-day status
    Extinguished Eligible
    Decision posted
    6/18/2019 6/18/2019
    First applicant approval
    18 May 2012
    First marketing
    20 Feb 2018
    Last qualifying patent expiry (as listed by FDA)
    19 Feb 2018

  • Extended-release Tablet · 80 mg

    RLD/NDA as listed: Solodyn 50808
    First PIV submission
    27 Oct 2010
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    8 Feb 2022
    First applicant approval
    25 Sep 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Feb 2018

Minocycline Hydrochloride

NDA 212379 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Aerosol Foam · 0.04

    RLD/NDA as listed: Amzeeq 212379
    First PIV submission
    11 May 2021
    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)
    8 Sep 2037

Minocycline Hydrochloride

NDA 213690 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Aerosol Foam · 1.4999999999999999E-2

    RLD/NDA as listed: Zilxi 213690
    First PIV submission
    28 Feb 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)
    1 Oct 2030

Minocyline Hydrochloride

NDA 219015 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 40 mg

    RLD/NDA as listed: Emrosi 219015
    First PIV submission
    16 Dec 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jan 2039

Minoxidil

NDA 021812 · 2 rows · Listed patents and exclusivities · Open in the app

  • Topical Aerosol Foam · 0.05

    RLD/NDA as listed: Men’s Rogaine 21812
    First PIV submission
    6 Apr 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    28 Apr 2011
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Apr 2019

  • Topical Aerosol Foam · 0.05

    RLD/NDA as listed: Women's Rogaine 21812
    First PIV submission
    4 Feb 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Apr 2022
    First applicant approval
    27 Jul 2017
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Apr 2019

Mirabegron

NDA 202611 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 25 mg

    RLD/NDA as listed: Myrbetriq 202611
    First PIV submission
    28 Jun 2016
    ANDAs
    6
    180-day status
    Extinguished Eligible
    Decision posted
    2/17/2025 10/4/2022
    First applicant approval
    27 Dec 2019
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Nov 2023

  • Extended-release Tablets · 50 mg

    RLD/NDA as listed: Myrbetriq 202611
    First PIV submission
    28 Jun 2016
    ANDAs
    6
    180-day status
    Extinguished Deferred
    Decision posted
    2/17/2025 10/4/2022
    First applicant approval
    28 Sep 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Nov 2023

Mirabegron

NDA 213801 · 1 row · Listed patents and exclusivities · Open in the app

  • Granules for Extended-release Suspension · 8 mg/mL

    RLD/NDA as listed: Myrbetriq Granules 213801
    First PIV submission
    12 Jan 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)
    31 Mar 2036

Mirtazapine

NDA 020415 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 7.5 mg, 15 mg, 30 mg, and 45 mg

    RLD/NDA as listed: Remeron 20415
    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

Mirtazapine

NDA 021208 · 1 row · Listed patents and exclusivities · Open in the app

  • Orally Disintegrating Tablets · 15 mg, 30 mg and 45 mg

    RLD/NDA as listed: Remeron SolTab 21208
    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

Mitapivat

NDA 216196 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg, 20 mg and 50 mg

    RLD/NDA as listed: Pyrukynd 216196
    First PIV submission
    17 Feb 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)
    31 Jul 2041

Mitomycin

NDA 211728 · 1 row · Listed patents and exclusivities · Open in the app

  • Powder for Injection · 40 mg/vial

    RLD/NDA as listed: Jelmyto 211728
    First PIV submission
    28 Dec 2023
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Jan 2031

Modafinil

NDA 020717 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg and 200 mg

    RLD/NDA as listed: Provigil 20717
    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

Moexipril Hydrochloride

NDA 020312 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 7.5 mg and 15 mg

    RLD/NDA as listed: Univasc 20312
    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

Moexipril Hydrochloride and Hydrochlorothiazide

NDA 020729 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 7.5mg/12.5mg, 15 mg/25 mg and 15 mg/12.5 mg

    RLD/NDA as listed: Uniretic 20729
    First PIV submission
    15 Jan 2004
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    7 Mar 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Feb 2007

Mometasone Furoate

NDA 019625 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Solution (Cream) · 0.1%

    RLD/NDA as listed: Elocon 19625
    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

Mometasone Furoate

NDA 019796 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Solution (Lotion) · 0.1%

    RLD/NDA as listed: Elocon 19796
    First PIV submission
    10 Jun 2004
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    6 Apr 2005
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Nov 2007

Mometasone Furoate

NDA 020762 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 50 mcg/ Spray

    RLD/NDA as listed: Nasonex 20762
    First PIV submission
    7 Aug 2009
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Feb 2022
    First applicant approval
    22 Mar 2016
    First marketing
    22 Mar 2016
    Last qualifying patent expiry (as listed by FDA)
    3 Oct 2017

Montelukast

NDA 020829 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg

    RLD/NDA as listed: Singulair 20829
    First PIV submission
    20 Feb 2007
    ANDAs
    2
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    3 Aug 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Feb 2012

Montelukast Sodium

NDA 020830 · 1 row · Listed patents and exclusivities · Open in the app

  • Chewable Tablets · 4 mg and 5 mg

    RLD/NDA as listed: Singulair 20830
    First PIV submission
    26 Dec 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    3 Aug 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Aug 2012

Montelukast Sodium

NDA 021409 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Granules · 4 mg

    RLD/NDA as listed: Singular Granules 21409
    First PIV submission
    17 Oct 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    3 Aug 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Aug 2012

Morphine Sulfate

NDA 021260 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 30 mg, 60 mg, 90 mg and 120 mg

    RLD/NDA as listed: Avinza 21260
    First PIV submission
    4 Jun 2007
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    10 Mar 2020
    First applicant approval
    16 Jan 2013
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Nov 2017

  • Extended-release Capsules · 45 mg and 75 mg

    RLD/NDA as listed: Avinza 21260
    First PIV submission
    11 Aug 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)
    25 Nov 2017

Morphine Sulfate

NDA 206544 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 15 mg, 30 mg, 60 mg and 100 mg

    RLD/NDA as listed: Morphabond ER 206544
    First PIV submission
    28 Jan 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)
    21 Aug 2028

Morphine Sulfate

NDA 208603 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 15 mg, 30 mg and 60 mg

    RLD/NDA as listed: Arymo ER 208603
    First PIV submission
    29 Dec 2017
    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)
    25 Nov 2017

Morphine Sulfate and Naltrexone Hydrochloride

NDA 022321 · 4 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 100 mg/4 mg

    RLD/NDA as listed: Embeda 22321
    First PIV submission
    3 May 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Jun 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Jun 2027

  • Extended-release Capsules · 20 mg/0.8 mg

    RLD/NDA as listed: Embeda 22321
    First PIV submission
    16 Aug 2018
    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)
    7 Nov 2029

  • Extended-release Capsules · 30 mg/1.2 mg 50 mg/2 mg 80 mg/3.2 mg

    RLD/NDA as listed: Embeda 22321
    First PIV submission
    28 May 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Jun 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Jun 2027

  • Extended-release Capsules · 60 mg/2.4 mg

    RLD/NDA as listed: Embeda 22321
    First PIV submission
    25 May 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Jun 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Jun 2027

Moxifloxacin Hydrochloride

NDA 021085 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 400 mg

    RLD/NDA as listed: Avelox 21085
    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

Moxifloxacin Hydrochloride

NDA 021277 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 1.6 mg/mL

    RLD/NDA as listed: Avelox in Sodium Chloride 0.8% in plastic container 21277
    First PIV submission
    7 Feb 2014
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Oct 2019
    First applicant approval
    5 May 2017
    First marketing
    3 Oct 2017
    Last qualifying patent expiry (as listed by FDA)
    25 Jul 2020

Moxifloxacin Hydrochloride

NDA 021598 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution/Drops · 5.0000000000000001E-3

    RLD/NDA as listed: Vigamox 21598
    First PIV submission
    22 Dec 2005
    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)
    20 Sep 2019

Moxifloxacin Hydrochloride

NDA 022428 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 5.0000000000000001E-3

    RLD/NDA as listed: Moxeza 22428
    First PIV submission
    29 Feb 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    28 May 2015
    First marketing
    28 May 2015
    Last qualifying patent expiry (as listed by FDA)
    20 Sep 2019

Mycophenolic Acid

NDA 050791 · 2 rows · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 180 mg

    RLD/NDA as listed: Myfortic 50791
    First PIV submission
    3 Jun 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    8 Jan 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Apr 2017

  • Delayed-release Tablets · 360 mg

    RLD/NDA as listed: Myfortic 50791
    First PIV submission
    2 Feb 2009
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    8 Feb 2022
    First applicant approval
    8 Jan 2014
    First marketing
    8 Jan 2014
    Last qualifying patent expiry (as listed by FDA)
    10 Apr 2017

Mycophenolic Mofetil

NDA 050759 · 1 row · Listed patents and exclusivities · Open in the app

  • For Oral Suspension · 200 mg/mL

    RLD/NDA as listed: Cellcept 50759
    First PIV submission
    25 Mar 2011
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Feb 2022
    First applicant approval
    14 Nov 2014
    First marketing
    17 Nov 2014
    Last qualifying patent expiry (as listed by FDA)
    18 Nov 2014