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Last Updated: August 3, 2020

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GLYCOPYRROLATE Drug Profile

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

Glycopyrrolate is a drug marketed by Abraxis Pharm, 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, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Orit Labs Llc, Oxford Pharms, Par Pharm, Renata, Rising, and Sun Pharm Inds Ltd. and is included in thirty-seven NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Glycopyrrolate

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

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Drug patent expirations by year for GLYCOPYRROLATE
Drug Prices for GLYCOPYRROLATE

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Recent Clinical Trials for GLYCOPYRROLATE

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SponsorPhase
Rajesh DesharN/A
King Saud UniversityPhase 4
Wonkwang University HospitalPhase 4

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Pharmacology for GLYCOPYRROLATE
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for GLYCOPYRROLATE
Paragraph IV (Patent) Challenges for GLYCOPYRROLATE
Tradename Dosage Ingredient NDA Submissiondate
CUVPOSA SOLUTION;ORAL glycopyrrolate 022571 2012-06-20
ROBINUL FORTE TABLET;ORAL glycopyrrolate 012827 2010-10-12
ROBINUL 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
Renata GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040568-002 Dec 22, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Natco Pharma Ltd GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 091413-002 Jun 20, 2016 AA RX No No   Start Trial   Start Trial   Start Trial
Watson Labs GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 086178-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040844-002 Aug 18, 2009 AA RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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