Is there a generic for Glycopyrrolate?

Yes. The FDA Orange Book lists 59 approved generic (ANDA) applications for Glycopyrrolate, referencing the brand GLYCOPYRROLATE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Glycopyrrolate?

GLYCOPYRROLATE (NDA 214919, FRESENIUS KABI USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Glycopyrrolate?

The Orange Book lists 11 patents against Glycopyrrolate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Glycopyrrolate are approved?

Glycopyrrolate is approved in the following dosage forms: injectable, powder, solution, tablet, tablet, orally disintegrating.

FDA Orange Book · active-ingredient family

Glycopyrrolate

Glycopyrrolate is approved as 9 brand and 59 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GLYCOPYRROLATE · NDA 214919

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, powder, solution, tablet, tablet, orally disintegrating

Product	Applicant	Application	TE	Approved
GLYCOPYRROLATERLD	FRESENIUS KABI USA	NDA 214919	—	Apr 21, 2022
DARTISLA ODTRLD×2	EDENBRIDGE PHARMS	NDA 215019	—	Dec 16, 2021
GLYRX-PFRLD×4	EXELA PHARMA	NDA 210997	—	Jul 11, 2018
LONHALA MAGNAIR KITRLD	SUMITOMO PHARMA AM	NDA 208437	—	Dec 05, 2017
SEEBRI NEOHALERRLD	NOVARTIS	NDA 207923	—	Oct 29, 2015
CUVPOSARLD	MERZ PHARMS	NDA 022571	AA	Jul 28, 2010
ROBINULRLD	HIKMA	NDA 017558	AP	Approved Prior to Jan 1, 1982
ROBINULRLD×2	CASPER PHARMA LLC	NDA 012827	AA	Approved Prior to Jan 1, 1982
ROBINUL	ROBINS AH	NDA 014764	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (59)

Product	Applicant	Application	TE	Approved
GLYCOPYRROLATE	QUAGEN	ANDA 216910	AA	May 18, 2026
GLYCOPYRROLATE	BIONPHARMA	ANDA 220062	AA	Dec 23, 2025
GLYCOPYRROLATE	AJENAT PHARMS	ANDA 219267	AA	Oct 27, 2025
GLYCOPYRROLATE	MSN	ANDA 216084	AA	Apr 08, 2025
GLYCOPYRROLATE	AUROBINDO PHARMA LTD	ANDA 214847	AA	Dec 31, 2024
GLYCOPYRROLATE	SCIEGEN PHARMS	ANDA 216297	AA	Oct 07, 2024
GLYCOPYRROLATE	CHARTWELL RX	ANDA 216368	AA	Aug 28, 2024
GLYCOPYRROLATE	GRANULES	ANDA 214735	AA	Aug 19, 2024
GLYCOPYRROLATE×2	QUAGEN	ANDA 212696	AA	Jul 10, 2024
GLYCOPYRROLATE	MANKIND PHARMA	ANDA 217354	—	Feb 27, 2023
GLYCOPYRROLATE	LUPIN	ANDA 213655	—	Feb 07, 2023
GLYCOPYRROLATE	OMNIVIUM PHARMS	ANDA 212871	AP	Nov 29, 2022
GLYCOPYRROLATE	ALEMBIC	ANDA 214635	AP	Oct 26, 2022
GLYCOPYRROLATE	AMNEAL	ANDA 215333	AP	Oct 21, 2022
GLYCOPYRROLATE	ANNORA PHARMA	ANDA 213698	AA	Jul 05, 2022
GLYCOPYRROLATE	SUVEN PHARMS	ANDA 212467	AA	Jul 05, 2022
GLYCOPYRROLATE	ZYDUS PHARMS	ANDA 214213	—	Nov 09, 2021
GLYCOPYRROLATE	NIVAGEN PHARMS INC	ANDA 212591	AP	Oct 13, 2021
GLYCOPYRROLATE	PH HEALTH	ANDA 204438	AA	Aug 09, 2021
GLYCOPYRROLATE	MEITHEAL	ANDA 212802	AP	Jul 06, 2021
GLYCOPYRROLATE	XIROMED	ANDA 212227	—	Mar 04, 2021
GLYCOPYRROLATE	ACCORD HLTHCARE	ANDA 213238	AP	Jul 08, 2020
GLYCOPYRROLATE	SAGENT	ANDA 210083	AP	Feb 21, 2020
GLYCOPYRROLATE	APOTEX	ANDA 210246	—	Oct 29, 2019
GLYCOPYRROLATE	GLAND	ANDA 212612	AP	Sep 30, 2019
GLYCOPYRROLATE	SANDOZ	ANDA 211334	AP	May 14, 2019
GLYCOPYRROLATE	CAPLIN	ANDA 211705	AP	Mar 20, 2019
GLYCOPYRROLATE×2	ALEMBIC	ANDA 203657	AA	Nov 30, 2018
GLYCOPYRROLATE	EUGIA PHARMA	ANDA 210244	—	Nov 28, 2018
GLYCOPYRROLATE	FRESENIUS KABI USA	ANDA 209024	AP	Oct 31, 2018
GLYCOPYRROLATE	PRINSTON INC	ANDA 210927	AP	Oct 31, 2018
GLYCOPYRROLATE	PIRAMAL CRITICAL	ANDA 210842	AP	Oct 25, 2018
GLYCOPYRROLATE	FRESENIUS KABI USA	ANDA 209328	AP	Oct 27, 2017
GLYCOPYRROLATE	SOMERSET THERAPS LLC	ANDA 207639	AP	Jun 23, 2017
GLYCOPYRROLATE	AMNEAL	ANDA 208973	AP	Jun 15, 2017
GLYCOPYRROLATE×2	APPCO	ANDA 207201	AA	Jan 03, 2017
GLYCOPYRROLATE×2	NATCO	ANDA 091413	AA	Jun 20, 2016
GLYCOPYRROLATE×2	REGCON HOLDINGS	ANDA 091182	AA	Feb 03, 2014
GLYCOPYRROLATE×2	AUROBINDO PHARMA	ANDA 202675	AA	Apr 15, 2013
GLYCOPYRROLATE×2	VELZEN PHARMA PVT	ANDA 090195	AA	Sep 21, 2012
GLYCOPYRROLATE	LGM PHARMA	ANDA 091522	—	Mar 12, 2012
GLYCOPYRROLATE×2	OXFORD PHARMS	ANDA 090020	AA	Oct 19, 2011
GLYCOPYRROLATE	HIKMA FARMACEUTICA	ANDA 090963	AP	Sep 21, 2011
GLYCOPYRROLATE×2	SUN PHARM INDS LTD	ANDA 040844	AA	Aug 18, 2009
GLYCOPYRROLATE×2	HIKMA INTL PHARMS	ANDA 040836	—	Mar 05, 2009
GLYCOPYRROLATE×2	RISING	ANDA 040821	AA	Dec 29, 2008
GLYCOPYRROLATE×2	CHARTWELL RX	ANDA 040847	AA	Mar 21, 2008
GLYCOPYRROLATE×2	PH HEALTH	ANDA 040653	AA	Aug 31, 2006
GLYCOPYRROLATE×2	CHARTWELL RX	ANDA 040568	—	Dec 22, 2004
GLYCOPYRROLATE	TEVA PARENTERAL	ANDA 081169	—	Sep 10, 1991
GLYCOPYRROLATE	HOSPIRA	ANDA 089393	—	Jun 15, 1988
GLYCOPYRROLATE	AM REGENT	ANDA 089335	AP	Jul 23, 1986
GLYCOPYRROLATE	ABRAXIS PHARM	ANDA 088475	—	Jun 12, 1984
GLYCOPYRROLATE	WATSON LABS	ANDA 086947	—	Jun 24, 1983
GLYCOPYRROLATE	WATSON LABS	ANDA 085562	—	Approved Prior to Jan 1, 1982
GLYCOPYRROLATE	WATSON LABS	ANDA 086902	—	Approved Prior to Jan 1, 1982
GLYCOPYRROLATE	WATSON LABS	ANDA 085563	—	Approved Prior to Jan 1, 1982
GLYCOPYRROLATE	WATSON LABS	ANDA 086178	—	Approved Prior to Jan 1, 1982
GLYCOPYRROLATE	WATSON LABS	ANDA 086900	—	Approved Prior to Jan 1, 1982

Listed patents (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11278683	Aug 16, 2026	in 2 mo	Product
8479730	Oct 11, 2028	in 2 yr 4 mo	Product
8182838	Oct 20, 2028	in 2 yr 4 mo	Product
9265900	Dec 07, 2028	in 2 yr 6 mo	Product
10940110	Feb 26, 2029	in 2 yr 9 mo	ProductU-1773
9789270	Oct 30, 2030	in 4 yr 5 mo	Product
9168556	Sep 01, 2032	in 6 yr 4 mo	Product
9604018	May 16, 2033	in 7 yr	Product
10376661	Sep 14, 2035	in 9 yr 4 mo	Product
10688518	Nov 12, 2036	in 10 yr 7 mo	Product
10744277	Dec 07, 2036	in 10 yr 7 mo	ProductU-2941

Glycopyrrolate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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