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Last Updated: March 19, 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
Dr Reddys Labs Ltd GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 040847-002 Mar 21, 2008 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sumitomo Pharma Am LONHALA MAGNAIR KIT glycopyrrolate SOLUTION;INHALATION 208437-001 Dec 5, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Watson Labs GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 086900-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 214213-001 Nov 9, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Casper Pharma Llc ROBINUL glycopyrrolate TABLET;ORAL 012827-001 Approved Prior to Jan 1, 1982 AA RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Exela Pharma GLYRX-PF glycopyrrolate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 210997-003 Apr 9, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 210244-001 Nov 28, 2018 DISCN 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
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
Merz Pharms CUVPOSA glycopyrrolate SOLUTION;ORAL 022571-001 Jul 28, 2010 ⤷  Try a Trial ⤷  Try a Trial
Sumitomo Pharma Am LONHALA MAGNAIR KIT glycopyrrolate SOLUTION;INHALATION 208437-001 Dec 5, 2017 ⤷  Try a Trial ⤷  Try a Trial
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 ⤷  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
Merz Pharms CUVPOSA glycopyrrolate SOLUTION;ORAL 022571-001 Jul 28, 2010 ⤷  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
World Intellectual Property Organization (WIPO) 2007020073 ⤷  Try a Trial
Denmark 1663155 ⤷  Try a Trial
Hong Kong 1092068 DRY POWDER COMPOSITION COMPRISING CO-JET MILLED PARTICLES FOR PULMONARY INHALATION ⤷  Try a Trial
European Patent Office 1663155 PREPARATIONS PHARMACEUTIQUES ET DISPOSITIFS LES DISTRIBUANT (DRY POWDER COMPOSITION COMPRISING CO-JET MILLED PARTICLES FOR PULMONARY INHALATION) ⤷  Try a Trial
Mexico 2008014892 AMPOLLA DESECHABLE PARA UN DISPOSITIVO GENERADOR DE AEROSOL. (DISPOSABLE AMPOULE FOR AN AEROSOL GENERATING DEVICE.) ⤷  Try a Trial
Norway 20054767 ⤷  Try a Trial
Spain 2423956 ⤷  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
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
2435025 2019C/532 Belgium ⤷  Try a Trial PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); 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
2435024 2021C/518 Belgium ⤷  Try a Trial PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.