GLYCOPYRROLATE Drug Patent Profile

When do Glycopyrrolate patents expire, and what generic alternatives are available?

Glycopyrrolate is a drug 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, Annora Pharma, Par Pharm Inc, Suven Pharms, Alembic Labs, Aurolife Pharma Llc, Chartwell Rx, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Lgm Pharma, Natco, Oxford Pharms, Par Pharm, Rising, and Sun Pharm Inds Ltd. and is included in forty-six NDAs.

The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Glycopyrrolate

A generic version of GLYCOPYRROLATE was approved as glycopyrrolate by AM REGENT on July 23^rd, 1986.

Summary for GLYCOPYRROLATE

US Patents:	0
Applicants:	39
NDAs:	46
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	145
Patent Applications:	3,766
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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
Tanta University	N/A
Emory University	Phase 4
Kangbuk Samsung Hospital	N/A

See all GLYCOPYRROLATE clinical trials

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

GLYCOPYRROLATE is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting GLYCOPYRROLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kenton	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	091182-002	Feb 3, 2014	AA	RX	No	No
Chartwell Rx	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	040568-001	Dec 22, 2004		DISCN	No	No
Par Pharm	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	040653-001	Aug 31, 2006	AA	RX	No	Yes
Natco	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	091413-001	Jun 20, 2016	AA	RX	No	No
Par Pharm	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	040653-002	Aug 31, 2006	AA	RX	No	Yes
Watson Labs	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	085562-001	Approved Prior to Jan 1, 1982		DISCN	No	No