GLYCOPYRROLATE - Generic Drug Details

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What are the generic sources for glycopyrrolate and what is the scope of freedom to operate?

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:	156
Patent Applications:	6,908
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
University of California, Irvine	Phase 4
Clayton Petro	Phase 4
Jie Chen	Phase 1/Phase 2

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	TABLET;ORAL	203657-002	Nov 30, 2018	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Oxford Pharms	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	090020-001	Oct 19, 2011	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	040844-002	Aug 18, 2009	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017	⤷ 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
Hong Kong	1092068	DRY POWDER COMPOSITION COMPRISING CO-JET MILLED PARTICLES FOR PULMONARY INHALATION	⤷ Sign Up
Spain	2673821		⤷ Sign Up
Russian Federation	2005135133	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ	⤷ 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
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
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
2435025	19C1040	France	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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