Drybench Patent.
FDA Paragraph IV list: I
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with I, 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.
Ibandronate Sodium
NDA 021455 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 150 mg
RLD/NDA as listed: Boniva 21455- First PIV submission
- 16 May 2007
- ANDAs
- 8
- 180-day status
- Deferred
- Decision posted
- 29 Jun 2020
- First applicant approval
- 19 Mar 2012
- First marketing
- 19 Mar 2012
- Last qualifying patent expiry (as listed by FDA)
- 6 May 2023
Tablets · 2.5 mg
RLD/NDA as listed: Boniva 21455- First PIV submission
- 16 May 2007
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 29 Jun 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 6 May 2023
Ibandronate Sodium
NDA 021858 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 1 mg/mL, 3 mL Vial
RLD/NDA as listed: Boniva 21858- First PIV submission
- 31 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)
- 2 Sep 2014
Ibrutinib
NDA 205552 · 2 rows · Listed patents and exclusivities · Open in the app
Capsules · 140 mg
RLD/NDA as listed: Imbruvica 205552- First PIV submission
- 13 Nov 2017
- ANDAs
- 8
- 180-day status
- Deferred
- Decision posted
- 6 Apr 2021
- First applicant approval
- 31 Mar 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Oct 2034
Capsules · 70 mg
RLD/NDA as listed: Imbruvica 205552- First PIV submission
- 14 Dec 2018
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 6 Apr 2021
- First applicant approval
- 31 Mar 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Oct 2033
Ibrutinib
NDA 210563 · 3 rows · Listed patents and exclusivities · Open in the app
Tablets · 140 mg
RLD/NDA as listed: Imbruvica 210563- First PIV submission
- 5 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)
- 3 Mar 2036
Tablets · 280 mg and 420 mg
RLD/NDA as listed: Imbruvica 210563- First PIV submission
- 14 Dec 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)
- 3 Mar 2036
Tablets · 560 mg
RLD/NDA as listed: Imbruvica 210563- First PIV submission
- 5 Nov 2018
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 8 Jul 2024
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 3 Mar 2036
Ibuprofen
NDA 020601 · 1 row · Listed patents and exclusivities · Open in the app
Chewable Tablets · 50 mg and 100 mg
RLD/NDA as listed: Children's Motrin, Junior Strength Motrin 20601- 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
Ibuprofen
NDA 020603 · 1 row · Listed patents and exclusivities · Open in the app
Oral Drops · 40 mg/mL
RLD/NDA as listed: Children's Motrin Drops 20603- 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
Ibuprofen
NDA 020812 · 1 row · Listed patents and exclusivities · Open in the app
Oral Suspension · 50 mg/1.25 mL
RLD/NDA as listed: Concentrated Motrin Infant Drops 20812- First PIV submission
- 29 Jun 2007
- 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 Dec 2011
Ibuprofen and Acetaminophen
NDA 211733 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 125 mg/250 mg
RLD/NDA as listed: Advil Dual Action with Acetaminophen 211733- First PIV submission
- 28 Mar 2024
- ANDAs
- 2
- 180-day status
- Eligible
- Decision posted
- 13 May 2024
- First applicant approval
- 26 Apr 2024
- First marketing
- 7 May 2024
- Last qualifying patent expiry (as listed by FDA)
- 9 Jul 2041
Ibuprofen and Diphenhydramine Citrate
NDA 021394 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 200 mg/38 mg
RLD/NDA as listed: Advil PM 21394- First PIV submission
- 28 Dec 2017
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 18 Apr 2023
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 May 2022
Ibuprofen and Diphenhydramine Hydrochloride
NDA 021393 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 200 mg/25 mg
RLD/NDA as listed: Advil PM 21393- First PIV submission
- 16 Feb 2016
- 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
Ibuprofen and Famotidine
NDA 022519 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 800 mg/26.6 mg
RLD/NDA as listed: Duexis 22519- First PIV submission
- 6 Dec 2011
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 24 Aug 2021
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 18 Jul 2026
Ibuprofen Lysine
NDA 021903 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 10 mg/mL, 2 mL vials
RLD/NDA as listed: Neoprofen 21903- First PIV submission
- 1 Oct 2010
- ANDAs
- 1
- 180-day status
- Extinguished Deferred
- Decision posted
- 4/18/2023 6/29/2020
- First applicant approval
- 30 Mar 2016
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 20 Mar 2021
Icatibant
NDA 022150 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 10 mg/mL
RLD/NDA as listed: Firazyr 22150- First PIV submission
- 25 Aug 2015
- ANDAs
- 2
- 180-day status
- Extinguished
- Decision posted
- 13 Aug 2019
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 15 Jul 2019
Icosapent Ethyl
NDA 202057 · 2 rows · Listed patents and exclusivities · Open in the app
Capsules · 1 g
RLD/NDA as listed: Vascepa 202057- First PIV submission
- 26 Jul 2016
- ANDAs
- 4
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 21 May 2020
- First marketing
- 4 Nov 2020
- Last qualifying patent expiry (as listed by FDA)
- 29 Apr 2030
Capsules · 500 mg
RLD/NDA as listed: Vascepa 202057- First PIV submission
- 29 Aug 2017
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 1 Dec 2020
- First applicant approval
- 11 Sep 2020
- First marketing
- 9 Sep 2022
- Last qualifying patent expiry (as listed by FDA)
- 29 Apr 2030
Idelalisib
NDA 205858 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 100 mg and 150 mg
RLD/NDA as listed: Zydelig 205858- First PIV submission
- 23 Mar 2022
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 2 Mar 2026
- First applicant approval
- 17 Feb 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 2 Sep 2033
Ifosfamide
NDA 019763 · 2 rows · Listed patents and exclusivities · Open in the app
For Injection · 1 g/vial and 3 g/vial
RLD/NDA as listed: Ifex 19763- 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
Ifosfamide/ Mesna · For Injection/ Injection Kit · 1 g/vial; 100 mg/mL, 10 mL vials and 3 g/vial; 100 mg/mL, 10 mL vials
RLD/NDA as listed: Ifex/ Mesnex Kit 19763- 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
Iloperidone
NDA 022192 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg
RLD/NDA as listed: Fanapt 22192- First PIV submission
- 6 May 2013
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 18 Jun 2019
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 15 Nov 2016
Imatinib Mesylate
NDA 021588 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 100 mg and 400 mg
RLD/NDA as listed: Gleevec 21588- First PIV submission
- 12 Mar 2007
- ANDAs
- 1
- 180-day status
- Non-forfeiture
- Decision posted
- 18 Jun 2019
- First applicant approval
- 3 Dec 2015
- First marketing
- 1 Feb 2016
- Last qualifying patent expiry (as listed by FDA)
- 23 Nov 2019
Imiquimod
NDA 020723 · 1 row · Listed patents and exclusivities · Open in the app
Cream · 5%
RLD/NDA as listed: Aldara 20723- First PIV submission
- 17 Oct 2006
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 29 Jun 2020
- First applicant approval
- 25 Feb 2010
- First marketing
- 25 Feb 2010
- Last qualifying patent expiry (as listed by FDA)
- 24 Aug 2010
Imiquimod
NDA 022483 · 2 rows · Listed patents and exclusivities · Open in the app
Cream · 2.5000000000000001E-2
RLD/NDA as listed: Zyclara 22483- First PIV submission
- 17 Jun 2014
- 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 Dec 2029
Cream · 3.7499999999999999E-2
RLD/NDA as listed: Zyclara 22483- First PIV submission
- 8 Aug 2012
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 16 Jul 2019
- First applicant approval
- blank
- First marketing
- 30 Jul 2020
- Last qualifying patent expiry (as listed by FDA)
- 11 Dec 2029
Inclisiran Sodium
NDA 214012 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 284 mg/1.5 mL
RLD/NDA as listed: Leqvio 214012- First PIV submission
- 22 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)
- 25 Aug 2036
Indocyanine Green
NDA 211580 · 1 row · Listed patents and exclusivities · Open in the app
For Injection · 25 mg/vial
RLD/NDA as listed: Spy Agent Green Kit 211580- First PIV submission
- 28 Nov 2022
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 14 Apr 2025
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 4 Aug 2035
Indomethacin
NDA 018185 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Capsules · 75 mg
RLD/NDA as listed: Indocin SR 18185- 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
Ingenol Mebutate
NDA 202833 · 2 rows · Listed patents and exclusivities · Open in the app
Gel · 1.4999999999999999E-4
RLD/NDA as listed: Picato 202833- First PIV submission
- 27 Jan 2016
- ANDAs
- 2
- 180-day status
- Eligible
- Decision posted
- 13 Aug 2019
- First applicant approval
- 7 Jan 2019
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 6 Jul 2027
Gel · 5.0000000000000001E-4
RLD/NDA as listed: Picato 202833- First PIV submission
- 27 Jan 2016
- ANDAs
- 2
- 180-day status
- Eligible
- Decision posted
- 13 Aug 2019
- First applicant approval
- 9 Jan 2019
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 6 Jul 2027
Ipratropium Bromide
NDA 021527 · 1 row · Listed patents and exclusivities · Open in the app
Inhalation Aerosol · 0.21 mg/Inh
RLD/NDA as listed: Atrovent HFA 21527- First PIV submission
- 29 Dec 2023
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 2 Mar 2026
- First applicant approval
- 23 Feb 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 17 Jan 2030
Irbesartan
NDA 020757 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 75 mg, 150 mg and 300 mg
RLD/NDA as listed: Avapro 20757- First PIV submission
- 25 May 2004
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 29 Jun 2020
- First applicant approval
- 30 Mar 2012
- First marketing
- 30 Mar 2012
- Last qualifying patent expiry (as listed by FDA)
- 7 Jun 2015
Irbesartan and Hydrochlorothiazide
NDA 020758 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 150 mg/12.5 mg and 300 mg/12.5 mg
RLD/NDA as listed: Avalide 20758- First PIV submission
- 10 Nov 2004
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 29 Jun 2020
- First applicant approval
- 30 Mar 2012
- First marketing
- 30 Mar 2012
- Last qualifying patent expiry (as listed by FDA)
- 7 Jun 2015
Tablets · 300 mg/25 mg
RLD/NDA as listed: Avalide 20758- First PIV submission
- 6 Jun 2006
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 29 Jun 2020
- First applicant approval
- 30 Mar 2012
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 7 Jun 2015
Irinotecan Hydrochloride
NDA 020571 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 20 mg/mL, 2 mL and 5 mL vials
RLD/NDA as listed: Camptosar 20571- First PIV submission
- 26 Jul 2004
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 29 Jun 2020
- First applicant approval
- 20 Feb 2008
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 1 May 2020
Isavuconazonium Sulfate
NDA 207500 · 2 rows · Listed patents and exclusivities · Open in the app
Capsules · 186 mg
RLD/NDA as listed: Cresemba 207500- First PIV submission
- 6 Sep 2024
- ANDAs
- 4
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Sep 2027
Capsules · 74.5 mg
RLD/NDA as listed: Cresemba 207500- First PIV submission
- 6 Sep 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)
- 14 Sep 2027
Isavuconazonium Sulfate
NDA 207501 · 1 row · Listed patents and exclusivities · Open in the app
For Injection · 372 mg/vial
RLD/NDA as listed: Cresemba 207501- First PIV submission
- 6 Sep 2024
- ANDAs
- 2
- 180-day status
- Extinguished
- Decision posted
- 5 Jan 2026
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 31 Oct 2025
Isotretinoin
NDA 021951 · 6 rows · Listed patents and exclusivities · Open in the app
Capsules · 10 mg
RLD/NDA as listed: Absorica 21951- First PIV submission
- 20 Jun 2013
- ANDAs
- 1
- 180-day status
- Eligible Deferred
- Decision posted
- 4/20/2021 4/6/2021
- First applicant approval
- 31 Mar 2021
- First marketing
- 31 Mar 2021
- Last qualifying patent expiry (as listed by FDA)
- 21 Sep 2021
Capsules · 20 mg
RLD/NDA as listed: Absorica 21951- First PIV submission
- 7 Jan 2013
- ANDAs
- 1
- 180-day status
- Eligible Deferred
- Decision posted
- 4/20/2021 4/6/2021
- First applicant approval
- 31 Mar 2021
- First marketing
- 31 Mar 2021
- Last qualifying patent expiry (as listed by FDA)
- 21 Sep 2021
Capsules · 25 mg
RLD/NDA as listed: Absorica 21951- First PIV submission
- 16 May 2016
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 6 Apr 2021
- First applicant approval
- 31 Mar 2021
- First marketing
- 31 Mar 2021
- Last qualifying patent expiry (as listed by FDA)
- 21 Sep 2021
Capsules · 30 mg
RLD/NDA as listed: Absorica 21951- First PIV submission
- 31 Dec 2012
- ANDAs
- 1
- 180-day status
- Eligible Deferred
- Decision posted
- 4/20/2021 4/6/2021
- First applicant approval
- 31 Mar 2021
- First marketing
- 31 Mar 2021
- Last qualifying patent expiry (as listed by FDA)
- 21 Sep 2021
Capsules · 35 mg
RLD/NDA as listed: Absorica 21951- First PIV submission
- 25 Nov 2015
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 6 Apr 2021
- First applicant approval
- 31 Mar 2021
- First marketing
- 31 Mar 2021
- Last qualifying patent expiry (as listed by FDA)
- 21 Sep 2021
Capsules · 40 mg
RLD/NDA as listed: Absorica 21951- First PIV submission
- 31 Dec 2012
- ANDAs
- 1
- 180-day status
- Extinguished Deferred
- Decision posted
- 4/20/2021 4/6/2021
- First applicant approval
- 31 Mar 2021
- First marketing
- 31 Mar 2021
- Last qualifying patent expiry (as listed by FDA)
- 21 Sep 2021
Istradefylline
NDA 022075 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 20 mg and 40 mg
RLD/NDA as listed: Nourianz 22075- First PIV submission
- 13 Aug 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 Jan 2028
Itraconazole
NDA 020083 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 100 mg
RLD/NDA as listed: Sporanox 20083- 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
Itraconazole
NDA 020657 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 10 mg/mL
RLD/NDA as listed: Sporanox 20657- First PIV submission
- 3 May 2013
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 29 Jun 2020
- First applicant approval
- 30 Oct 2015
- First marketing
- 18 Sep 2018
- Last qualifying patent expiry (as listed by FDA)
- 18 Jun 2019
Ivabradine
NDA 206143 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg and 7.5 mg
RLD/NDA as listed: Corlanor 206143- First PIV submission
- 15 Oct 2019
- ANDAs
- 6
- 180-day status
- Eligible
- Decision posted
- 11 Jan 2022
- First applicant approval
- 30 Dec 2021
- First marketing
- 5 Oct 2022
- Last qualifying patent expiry (as listed by FDA)
- 22 Feb 2026
Ivacaftor
NDA 203188 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 150 mg
RLD/NDA as listed: Kalydeco 203188- First PIV submission
- 10 Jun 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)
- 13 Aug 2029
Ivacaftor
NDA 207925 · 1 row · Listed patents and exclusivities · Open in the app
Oral Granules · 25 mg, 50 mg and 75 mg
RLD/NDA as listed: Kalydeco 207925- First PIV submission
- 13 Apr 2022
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 27 Feb 2033
Ivermectin
NDA 202736 · 1 row · Listed patents and exclusivities · Open in the app
Lotion · 5.0000000000000001E-3
RLD/NDA as listed: Sklice 202736- First PIV submission
- 1 Sep 2017
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 6 May 2020
- First marketing
- 30 Nov 2020
- Last qualifying patent expiry (as listed by FDA)
- 12 Oct 2027
Ivermectin
NDA 206255 · 1 row · Listed patents and exclusivities · Open in the app
Cream · 0.01
RLD/NDA as listed: Soolantra 206255- First PIV submission
- 30 Dec 2016
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 2 Jan 2020
- First applicant approval
- 13 Sep 2019
- First marketing
- 14 Oct 2019
- Last qualifying patent expiry (as listed by FDA)
- 13 Mar 2034
Ivosidenib
NDA 211192 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 250 mg
RLD/NDA as listed: Tibsovo 211192- First PIV submission
- 20 Jul 2022
- 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 Jun 2039
Ixabepilon
NDA 022065 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 15 mg/vial and 45 mg/vial, single-use vials
RLD/NDA as listed: Ixempra Kit 22065- First PIV submission
- 16 Apr 2012
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 18 Apr 2023
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 8 Feb 2022
Ixazomib Citrate
NDA 208462 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 2.3 mg, 3 mg and 4 mg
RLD/NDA as listed: Ninlaro 208462- First PIV submission
- 20 Nov 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)
- 20 Nov 2029