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Last Updated: March 28, 2024

GLYCOPYRROLATE Drug Patent Profile


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Which patents cover Glycopyrrolate, and when can generic versions of Glycopyrrolate launch?

Glycopyrrolate is a drug 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, Piramal Critical, Prinston Inc, Sagent, Sandoz, Somerset Theraps Llc, Teva Parenteral, Umedica, Watson Labs, Xiromed, Zydus Pharms, Annora Pharma, Par Pharm Inc, Suven Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Indoco, Leading, Lgm Pharma, Natco, Oxford Pharms, Par Pharm, Rising, and Sun Pharm Inds Ltd. and is included in fifty-one NDAs.

The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-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 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
National Trauma CenterN/A
Merck Sharp & Dohme LLCPhase 4
Ciusss de L'Est de l'Île de MontréalN/A

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Medical Subject Heading (MeSH) Categories for GLYCOPYRROLATE
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
Heritage Pharms Inc GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 207201-001 Jan 3, 2017 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Suven Pharms GLYCOPYRROLATE glycopyrrolate SOLUTION;ORAL 212467-001 Jul 5, 2022 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lgm Pharma GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 091522-001 Mar 12, 2012 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 085562-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Indoco GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 091182-001 Feb 3, 2014 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Natco GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 091413-001 Jun 20, 2016 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040653-002 Aug 31, 2006 AA RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.