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Last Updated: October 6, 2022

GLYCOPYRROLATE Drug Patent Profile


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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.

Drug patent expirations by year for GLYCOPYRROLATE
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Recent Clinical Trials for GLYCOPYRROLATE

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SponsorPhase
Tanta UniversityN/A
Emory UniversityPhase 4
Kangbuk Samsung HospitalN/A

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Pharmacology for GLYCOPYRROLATE
Drug ClassAnticholinergic
Mechanism of Action Cholinergic Antagonists
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

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

FDA Regulatory Exclusivity protecting GLYCOPYRROLATE

PATENT CHALLENGE
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Rx GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040568-001 Dec 22, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Par Pharm GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040653-001 Aug 31, 2006 AA RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Natco GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 091413-001 Jun 20, 2016 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Par Pharm GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040653-002 Aug 31, 2006 AA RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 085562-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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.