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Last Updated: March 28, 2024

Glycopyrrolate - Generic Drug Details


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What are the generic drug sources for glycopyrrolate and what is the scope of patent protection?

Glycopyrrolate is the generic ingredient in ten branded drugs 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, Hikma, Robins Ah, Novartis, Sumitomo Pharma Am, Exela Pharma, Merz Pharms, Annora Pharma, Par Pharm Inc, Suven Pharms, Edenbridge 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, Sun Pharm Inds Ltd, Casper Pharma Llc, and Slayback Pharma Llc, and is included in sixty-one NDAs. There are sixteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Glycopyrrolate has one hundred and seventy-five patent family members in thirty-two countries.

There are seventeen drug master file entries for glycopyrrolate. Fifty-five suppliers are listed for this compound.

Drug Prices for glycopyrrolate

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Recent Clinical Trials for glycopyrrolate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Trauma CenterN/A
Merck Sharp & Dohme LLCPhase 4
Ciusss de L'Est de l'Île de MontréalN/A

See all glycopyrrolate clinical trials

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
Robins Ah ROBINUL glycopyrrolate INJECTABLE;INJECTION 014764-001 Approved Prior to Jan 1, 1982 DISCN 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
Watson Labs GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 086947-001 Jun 24, 1983 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040821-001 Dec 29, 2008 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for glycopyrrolate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merz Pharms CUVPOSA glycopyrrolate SOLUTION;ORAL 022571-001 Jul 28, 2010 ⤷  Try a Trial ⤷  Try a Trial
Casper Pharma Llc ROBINUL FORTE glycopyrrolate TABLET;ORAL 012827-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for glycopyrrolate

Country Patent Number Title Estimated Expiration
European Patent Office 1613323 COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE L'APOMORPHINE POUR L'INHALATION PULMONAIRE (PHARMACEUTICAL COMPOSITIONS COMPRISING APOMORHINE FOR PULMONARY INHALATION) ⤷  Try a Trial
Spain 2434845 ⤷  Try a Trial
Australia 2009241628 Method and system for the treatment of chronic obstructive pulmonary disease with nebulized anticholinergic administrations ⤷  Try a Trial
Australia 2008249155 Disposable Ampoule for an Aerosol Generating Device ⤷  Try a Trial
Russian Federation 2006143840 ИНГАЛЯТОР ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for glycopyrrolate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 2190014-7 Sweden ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435025 19C1040 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220
2435025 LUC00124 Luxembourg ⤷  Try a Trial PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435024 21C1020 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024 SPC/GB21/029 United Kingdom ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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