Glycopyrrolate - Generic Drug Details

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

Glycopyrrolate is the generic ingredient in nine branded drugs marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal, Apotex, Athenex Inc, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Meitheal, Nivagen Pharms Inc, Piramal Critical, Prinston Inc, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Xiromed, Zydus Pharms, Hikma, Robins Ah, Novartis, Sunovion Resp, Exela Pharma, Merz Pharms, Par Pharm Inc, Edenbridge Pharms, Alembic Labs, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Lgm Pharma, Natco, Oxford Pharms, Par Pharm, Renata, Rising, Sun Pharm Inds Ltd, and Casper Pharma Llc, and is included in fifty-two NDAs. There are eighteen 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 eighty-two patent family members in thirty-two countries.

There are seventeen drug master file entries for glycopyrrolate. Forty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for glycopyrrolate

International Patents:	182
US Patents:	18
Tradenames:	9
Applicants:	45
NDAs:	52
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	144
Patent Applications:	6,761
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
Emory University	Phase 4
Kangbuk Samsung Hospital	N/A
SMG-SNU Boramae Medical Center	N/A

See all glycopyrrolate clinical trials

Generic filers with tentative approvals for GLYCOPYRROLATE

Applicant	Application No.	Strength	Dosage Form
		1MG/5ML	SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for glycopyrrolate

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic 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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Caplin	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	211705-001	Mar 20, 2019	AP	RX	No	No
Sunovion Resp	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		RX	Yes	Yes			Y
Exela Pharma	GLYRX-PF	glycopyrrolate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	210997-003	Apr 9, 2020		RX	Yes	Yes
Sunovion Resp	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		RX	Yes	Yes			Y
Meitheal	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	212802-001	Jul 6, 2021	AP	RX	No	No
Kenton	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	091182-001	Feb 3, 2014	AA	RX	No	No

Expired US Patents for glycopyrrolate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Sunovion Resp	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015

International Patents for glycopyrrolate

Country	Patent Number	Title	Estimated Expiration
Norway	20065718
European Patent Office	1663164	PROCEDES DE PREPARATION DE COMPOSITIONS PHARMACEUTIQUES (METHODS FOR PREPARING PHARMACEUTICAL COMPOSITIONS)
United Kingdom	201008994
European Patent Office	1613323	COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE L'APOMORPHINE POUR L'INHALATION PULMONAIRE (PHARMACEUTICAL COMPOSITIONS COMPRISING APOMORHINE FOR PULMONARY INHALATION)
China	1882318	Dry powder composition comprising co-jet milled particles for pulmonary inhalation
Singapore	146648	PHARMACEUTICAL COMPOSITIONS FOR TREATING PREMATURE EJACULATION BY PULMONARY INHALATION

Supplementary Protection Certificates for glycopyrrolate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435025	LUC00124	Luxembourg		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	21C1020	France		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	19C1040	France		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
2435025	2019C/532	Belgium		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220