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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 eight branded drugs marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal, Apotex, Aurobindo Pharma Ltd, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Piramal Critical, Prinston Inc, Riconpharma Llc, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Hikma, Robins Ah, Novartis, Sunovion Resp, Exela Pharma, Merz Pharms, Alembic Labs, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Lgm Pharma, Natco Pharma Ltd, Oxford Pharms, Par Pharm, Renata, Rising, Sun Pharm Inds Ltd, and Casper Pharma Llc, and is included in forty-six NDAs. There are thirty-two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Glycopyrrolate has four hundred and fifteen patent family members in forty-one countries.

There are seventeen drug master file entries for glycopyrrolate. There is one tentative approval for this compound.

Summary for glycopyrrolate

International Patents:	415
US Patents:	32
Tradenames:	8
Applicants:	39
NDAs:	46
Drug Master File Entries:	17
Bulk Api Vendors:	87
Clinical Trials:	133
Patent Applications:	4,255
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for glycopyrrolate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for glycopyrrolate
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
Temple University	Phase 4
Tanta University	Phase 1
Rajesh Deshar	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.

Medical Subject Heading (MeSH) Categories for glycopyrrolate

Adjuvants, Anesthesia

Muscarinic Antagonists

Paragraph IV (Patent) Challenges for GLYCOPYRROLATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
CUVPOSA	SOLUTION;ORAL	glycopyrrolate	022571	2012-06-20
ROBINUL	TABLET;ORAL	glycopyrrolate	012827	2010-10-12
ROBINUL FORTE	TABLET;ORAL	glycopyrrolate	012827	2010-10-12
ROBINUL FORTE	TABLET;ORAL	glycopyrrolate	012827	2009-08-14
ROBINUL	TABLET;ORAL	glycopyrrolate	012827	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
Watson Labs	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	086947-001	Jun 24, 1983		DISCN	No	No
Casper Pharma Llc	ROBINUL FORTE	glycopyrrolate	TABLET;ORAL	012827-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Watson Labs	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	086178-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015		DISCN	Yes	No			Y
Hospira	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	089393-001	Jun 15, 1988		DISCN	No	No
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015		DISCN	Yes	No
Aurolife Pharma Llc	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	202675-001	Apr 15, 2013	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
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

International Patents for glycopyrrolate

Country	Patent Number	Estimated Expiration
Czech Republic	20023437
United Kingdom	0029265
Germany	102005038619
Singapore	146648
Mexico	PA02010212
European Patent Office	2883564
European Patent Office	1274406

Supplementary Protection Certificates for glycopyrrolate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1267866	SPC/GB13/020	United Kingdom		PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTERED: UK EU/1/12/788/001 20120928; UK EU/1/12/788/002 20120928; UK EU/1/12/788/003 20120928; UK EU/1/12/788/004 20120928; UK EU/1/12/788/005 20120928; UK EU/1/12/788/006 20120928
1267866	122013000029	Germany		PRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866	132013902141564	Italy		PRODUCT NAME: GLICOPIRRONIO BROMURO(SEEBRI BREEZHALER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/788/001-006, 20120928
1267866	300583	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1267866	C300583	Netherlands		PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866	2014C/022	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), AUTRE, ADRESSE (NO SUPPRIME)
1267866	493	Finland