Drybench Patent.
FDA Paragraph IV list: G
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with G, 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.
Gabapentin
NDA 020235 · 2 rows · Listed patents and exclusivities · Open in the app
Capsules · 100 mg, 300 mg and 400 mg
RLD/NDA as listed: Neurontin 20235- 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 · 100 mg, 300 mg and 400 mg
RLD/NDA as listed: Neurontin 20235- 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
Gabapentin
NDA 020882 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 600 mg and 800 mg
RLD/NDA as listed: Neurontin 20882- 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
Gabapentin
NDA 021129 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 250 mg/5 mL
RLD/NDA as listed: Neurontin 21129- 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
Gabapentin
NDA 022544 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 300 mg and 600 mg
RLD/NDA as listed: Gralise 22544- First PIV submission
- 31 Oct 2011
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 22 Jan 2024
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 26 Feb 2024
Gabapentin Enacarbil
NDA 022399 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 300 mg and 600 mg
RLD/NDA as listed: Horizant 22399- First PIV submission
- 29 Apr 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 Jun 2029
Galantamine Hydrobromide
NDA 021169 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 4 mg, 8 mg and 12 mg
RLD/NDA as listed: Razadyne 21169- First PIV submission
- 28 Feb 2005
- ANDAs
- 14
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 28 Aug 2008
- First marketing
- 28 Aug 2008
- Last qualifying patent expiry (as listed by FDA)
- 6 Jun 2017
Galantamine Hydrobromide
NDA 021615 · 2 rows · Listed patents and exclusivities · Open in the app
Extended-release Capsules · 16 mg and 24 mg
RLD/NDA as listed: Razadyne ER 21615- First PIV submission
- 11 Mar 2006
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 15 Sep 2008
- First marketing
- 15 Oct 2008
- Last qualifying patent expiry (as listed by FDA)
- 20 Dec 2019
Extended-release Capsules · 8 mg
RLD/NDA as listed: Razadyne ER 21615- First PIV submission
- 2 Mar 2006
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 15 Sep 2008
- First marketing
- 15 Oct 2008
- Last qualifying patent expiry (as listed by FDA)
- 20 Dec 2019
Ganciclovir Sodium
NDA 020460 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 250 mg and 500 mg
RLD/NDA as listed: Cytovene 20460- 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
Ganirelix Acetate
NDA 021057 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 250 mcg/0.5 mL, 1 mL PFS
RLD/NDA as listed: Ganirelix Acetate 21057- First PIV submission
- 30 Mar 2012
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 27 Jan 2020
- First applicant approval
- 30 Nov 2018
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 16 Jun 2015
Gatifloxacin
NDA 021493 · 1 row · Listed patents and exclusivities · Open in the app
Ophthalmic Solution · 0.3 %
RLD/NDA as listed: Zymar 21493- First PIV submission
- 19 Jul 2007
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 19 Aug 2011
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 20 Aug 2019
Gatifloxacin
NDA 022548 · 1 row · Listed patents and exclusivities · Open in the app
Ophthalmic Solution · 0.5 %
RLD/NDA as listed: Zymaxid 22548- First PIV submission
- 7 Dec 2010
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 28 Aug 2013
- First marketing
- 1 Oct 2013
- Last qualifying patent expiry (as listed by FDA)
- 20 Aug 2019
Gemcitabine
NDA 020509 · 2 rows · Listed patents and exclusivities · Open in the app
For Injection · 1g/vial
RLD/NDA as listed: Gemzar 20509- First PIV submission
- 14 Nov 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 25 Jan 2011
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 7 Nov 2012
For Injection · 200 mg/vial
RLD/NDA as listed: Gemzar 20509- First PIV submission
- 1 Nov 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 18 Dec 2008
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 7 Nov 2012
Gemifloxacin Mesylate
NDA 021158 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 320 mg
RLD/NDA as listed: Factive 21158- First PIV submission
- 4 Mar 2008
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 18 Jun 2019
- First applicant approval
- 15 Jun 2015
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 21 Sep 2019
Gilteritinib Fumarate
NDA 211349 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 40 mg
RLD/NDA as listed: Xospata 211349- First PIV submission
- 28 Nov 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)
- 1 Jul 2036
Glatiramer Acetate
NDA 020622 · 2 rows · Listed patents and exclusivities · Open in the app
Injection · 20 mg/mL, 1mL pre-filled syringe
RLD/NDA as listed: Copaxone 20622- First PIV submission
- 27 Dec 2007
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 25 Feb 2020
- First applicant approval
- 16 Apr 2015
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 May 2014
Injection · 40 mg/mL, 1 mL pre-filled syringe
RLD/NDA as listed: Copaxone 20622- First PIV submission
- 26 Feb 2014
- ANDAs
- 2
- 180-day status
- Deferred
- Decision posted
- 25 Feb 2020
- First applicant approval
- 3 Oct 2017
- First marketing
- 4 Oct 2017
- Last qualifying patent expiry (as listed by FDA)
- 19 Aug 2030
Glimepiride and Rosiglitazone Maleate
NDA 021700 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 1 mg/4 mg 2 mg/4 mg 4 mg/4 mg
RLD/NDA as listed: Avandaryl 21700- First PIV submission
- 22 Dec 2006
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 15 Jun 2020
- First applicant approval
- 1 Apr 2016
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 21 Oct 2015
Tablets · 8 mg/2 mg 8 mg/4 mg
RLD/NDA as listed: Avandaryl 21700- First PIV submission
- 30 May 2008
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 1 Apr 2016
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 19 Oct 2020
Glipizide
NDA 020329 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 2.5 mg, 5 mg and 10 mg
RLD/NDA as listed: Glucotrol XL 20329- 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
Glyburide
NDA 020051 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 1.5 mg, 3 mg, 4.5 mg and 6 mg
RLD/NDA as listed: Glynase 20051- 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
Glyburide/_x000D_ Metformin Hydrochloride
NDA 021178 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 1.25mg/250 mg 2.5 mg/500 mg 5 mg/500 mg
RLD/NDA as listed: Glucovance 21178- 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
Glycerol Phenylbutyrate
NDA 203284 · 1 row · Listed patents and exclusivities · Open in the app
Oral Liquid · 1.1 g/mL
RLD/NDA as listed: Ravicti 203284- First PIV submission
- 19 Nov 2013
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 11 Jan 2022
- First applicant approval
- 2 Dec 2021
- First marketing
- 17 Oct 2025
- Last qualifying patent expiry (as listed by FDA)
- 9 Mar 2032
Glycopyrrolate
NDA 012827 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 1 mg
RLD/NDA as listed: Robinul 12827- First PIV submission
- 14 Aug 2009
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 10 Mar 2020
- First applicant approval
- 3 Feb 2014
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Apr 2024
Tablets · 2 mg
RLD/NDA as listed: Robinul Forte 12827- First PIV submission
- 12 Oct 2010
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 3 Feb 2014
- First marketing
- 21 Dec 2015
- Last qualifying patent expiry (as listed by FDA)
- 24 Apr 2024
Glycopyrrolate
NDA 022571 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 1 mg/5 mL
RLD/NDA as listed: Cuvposa 22571- First PIV submission
- 20 Jun 2012
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 24 Aug 2021
- First applicant approval
- 9 Aug 2021
- First marketing
- 4 Jan 2022
- Last qualifying patent expiry (as listed by FDA)
- 20 Aug 2023
Glycopyrronium Tosylate
NDA 210361 · 1 row · Listed patents and exclusivities · Open in the app
Topical Cloth · 2.4E-2
RLD/NDA as listed: Qbrexza 210361- First PIV submission
- 13 Jan 2020
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 13 Apr 2026
- First applicant approval
- 3 Apr 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 28 Feb 2033
Granisetron Hydrochloride
NDA 020239 · 3 rows · Listed patents and exclusivities · Open in the app
Injection · 0.1 mg/mL, 1 mL single dose vial
RLD/NDA as listed: Kytril 20239- First PIV submission
- 8 Mar 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)
- blank
Injection · 1 mg/mL, 1 mL vials
RLD/NDA as listed: Kytril 20239- First PIV submission
- 1 Jun 2004
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 31 Dec 2007
- First marketing
- 31 Dec 2007
- Last qualifying patent expiry (as listed by FDA)
- 4 May 2019
Injection · 1 mg/mL, 4 mL multi-dose vials
RLD/NDA as listed: Kytril 20239- First PIV submission
- 19 Jul 2004
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 31 Dec 2007
- First marketing
- 31 Dec 2007
- Last qualifying patent expiry (as listed by FDA)
- 4 May 2019
Granisetron Hydrochloride
NDA 022198 · 1 row · Listed patents and exclusivities · Open in the app
Transdermal System · 3.1 mg/24 hrs
RLD/NDA as listed: Sancuso 22198- First PIV submission
- 9 Oct 2015
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 22 Oct 2024
Guaifenesin
NDA 021282 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 600 mg and 1.2 gm
RLD/NDA as listed: Mucinex 21282- First PIV submission
- 9 Jun 2006
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 19 Nov 2019
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 28 Apr 2020
Guaifenesin and Dextromethorphan
NDA 021620 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 600 mg/30 mg and 1200 mg/60 mg
RLD/NDA as listed: Mucinex DM 21620- First PIV submission
- 17 Dec 2008
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 15 Jun 2020
- First applicant approval
- 31 Aug 2015
- First marketing
- 5 Apr 2016
- Last qualifying patent expiry (as listed by FDA)
- 28 Apr 2020
Guaifenesin and Pseudoephedrine Hydrochloride
NDA 021585 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 600 mg/60 mg and 1200 mg/120 mg
RLD/NDA as listed: Mucinex-D 21585- First PIV submission
- 29 Dec 2008
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 15 Jun 2020
- First applicant approval
- 27 May 2015
- First marketing
- 16 Dec 2015
- Last qualifying patent expiry (as listed by FDA)
- 28 Apr 2020
Guanfacine Hydrochloride
NDA 022037 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 1 mg, 2 mg, 3 mg and 4 mg
RLD/NDA as listed: Intuniv 22037- First PIV submission
- 29 Dec 2009
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 29 Jun 2020
- First applicant approval
- 5 Oct 2012
- First marketing
- 1 Dec 2014
- Last qualifying patent expiry (as listed by FDA)
- 4 Jul 2022