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, Endo Operations, 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, Rising, Sun Pharm Inds Ltd, Casper Pharma Llc, and Azurity, and is included in sixty-one NDAs. There are seventeen 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:	17
Tradenames:	10
Applicants:	50
NDAs:	61
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	55
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	153
Patent Applications:	6,826
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
Suven Pharms	GLYCOPYRROLATE	glycopyrrolate	SOLUTION;ORAL	212467-001	Jul 5, 2022	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	213238-001	Jul 8, 2020	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015	⤷ Sign Up	⤷ Sign Up
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015	⤷ Sign Up	⤷ Sign Up
>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
Japan	2014158978	DEVICES AND PHARMACEUTICAL COMPOSITIONS FOR ENHANCING DOSING EFFICIENCY	⤷ Sign Up
European Patent Office	1919542	DISPOSITIF DE THERAPIE PAR INHALATION POURVU D'UNE AMPOULE DESTINEE A CONTENIR UN MEDICAMENT A NEBULISER (INHALATION THERAPY DEVICE COMPRISING AN AMPOULE FOR HOLDING A DRUG TO BE ATOMIZED)	⤷ Sign Up
South Africa	200602747	Pharmaceutical compositions for treating premature ejaculation by pulmonary inhalation	⤷ Sign Up
>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	LUC00124	Luxembourg	⤷ Sign Up	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	⤷ Sign Up	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
2435024	21C1020	France	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.