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Last Updated: April 28, 2024

Glycopyrrolate - Generic Drug Details

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What are the generic sources for glycopyrrolate and what is the scope of patent protection?

Glycopyrrolate is the generic ingredient in ten branded drugs marketed by Abraxis Pharm, Accord Hlthcare, Alembic, Am Regent, Amneal, Apotex, Aspen, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Lupin Ltd, Mankind Pharma, Meitheal, Nivagen Pharms Inc, Piramal Critical, Prinston Inc, Sagent, Sandoz, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Xiromed, Zydus Pharms, Hikma, Robins Ah, Novartis, Sumitomo Pharma Am, Exela Pharma, Merz Pharms, Annora Pharma, Par Pharm Inc, Suven Pharms, Edenbridge Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Indoco, Leading, Lgm Pharma, Natco, Oxford Pharms, Par Pharm, Rising, Sun Pharm Inds Ltd, Casper Pharma Llc, and Azurity, and is included in sixty-one NDAs. There are sixteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Glycopyrrolate has one hundred and seventy-five patent family members in thirty-two countries.

There are seventeen drug master file entries for glycopyrrolate. Fifty-five suppliers are listed for this compound.

Summary for glycopyrrolate

International Patents:	175
US Patents:	16
Tradenames:	10
Applicants:	51
NDAs:	61
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	55
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	153
Patent Applications:	6,853
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for glycopyrrolate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for glycopyrrolate
What excipients (inactive ingredients) are in glycopyrrolate?	glycopyrrolate excipients list
DailyMed Link:	glycopyrrolate at DailyMed

See drug prices for glycopyrrolate

Recent Clinical Trials for glycopyrrolate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Trauma Center	N/A
Merck Sharp & Dohme LLC	Phase 4
Ciusss de L'Est de l'Île de Montréal	N/A

See all glycopyrrolate clinical trials

Pharmacology for glycopyrrolate

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for glycopyrrolate

Adjuvants, Anesthesia
Muscarinic Antagonists

Paragraph IV (Patent) Challenges for GLYCOPYRROLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CUVPOSA	Oral Solution	glycopyrrolate	1 mg/5 mL	022571	1	2012-06-20
ROBINUL FORTE	Tablets	glycopyrrolate	2 mg	012827	1	2010-10-12
ROBINUL FORTE	Tablets	glycopyrrolate	1 mg	012827	1	2009-08-14

US Patents and Regulatory Information for glycopyrrolate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	214635-001	Oct 26, 2022	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	208973-001	Jun 15, 2017	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Annora Pharma	GLYCOPYRROLATE	glycopyrrolate	SOLUTION;ORAL	213698-001	Jul 5, 2022	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	089393-001	Jun 15, 1988		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for glycopyrrolate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015	⤷ Try a Trial	⤷ Try a Trial
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015	⤷ Try a Trial	⤷ Try a Trial
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015	⤷ Try a Trial	⤷ Try a Trial
Casper Pharma Llc	ROBINUL	glycopyrrolate	TABLET;ORAL	012827-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for glycopyrrolate

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Country	Patent Number	Title	Estimated Expiration
China	104619303	Opening element for opening an ampoule in an aerosol generation device and aerosol generation device comprising the opening element	⤷ Try a Trial
European Patent Office	2708219	Élément d'ouverture pour ouvrir une ampoule dans un dispositif de génération d'aérosol et dispositif de génération d'aérosol comprenant l'élément d'ouverture (Opening element for opening an ampoule in an aerosol generation device and aerosol generation device comprising the opening element)	⤷ Try a Trial
Tunisia	SN06367	INHALER DEVICE	⤷ Try a Trial
Japan	2014158978	DEVICES AND PHARMACEUTICAL COMPOSITIONS FOR ENHANCING DOSING EFFICIENCY	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for glycopyrrolate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	19C1040	France	⤷ Try a Trial	PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220
2435024	21C1020	France	⤷ Try a Trial	PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435025	LUC00124	Luxembourg	⤷ Try a Trial	PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435024	SPC/GB21/029	United Kingdom	⤷ Try a Trial	PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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