You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: October 31, 2024

Glycopyrrolate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic 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, Chartwell Rx, Endo Operations, Granules, Suven Pharms, Edenbridge Pharms, Adaptis, Aurobindo Pharma, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Lgm Pharma, Natco, Oxford Pharms, Quagen, Rising, Sun Pharm Inds Ltd, Velzen Pharma Pvt, Casper Pharma Llc, and Azurity, and is included in sixty-four NDAs. There are seventeen 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-six suppliers are listed for this compound.

Drug Prices for glycopyrrolate

See drug prices for glycopyrrolate

Recent Clinical Trials for glycopyrrolate

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

SponsorPhase
University of California, IrvinePhase 4
Clayton PetroPhase 4
Jie ChenPhase 1/Phase 2

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
Fresenius Kabi Usa GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 209024-001 Oct 31, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx GLYCOPYRROLATE glycopyrrolate SOLUTION;ORAL 216368-001 Aug 28, 2024 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Granules GLYCOPYRROLATE glycopyrrolate SOLUTION;ORAL 214735-001 Aug 19, 2024 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meitheal GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 212802-001 Jul 6, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sumitomo Pharma Am LONHALA MAGNAIR KIT glycopyrrolate SOLUTION;INHALATION 208437-001 Dec 5, 2017 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Sumitomo Pharma Am LONHALA MAGNAIR KIT glycopyrrolate SOLUTION;INHALATION 208437-001 Dec 5, 2017 ⤷  Sign Up ⤷  Sign Up
Casper Pharma Llc ROBINUL glycopyrrolate TABLET;ORAL 012827-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Merz Pharms CUVPOSA glycopyrrolate SOLUTION;ORAL 022571-001 Jul 28, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for glycopyrrolate

Country Patent Number Title Estimated Expiration
Spain 2377205 ⤷  Sign Up
Germany 102005038619 Inhalationstherapievorrichtung mit einer Ampulle für die Bevorratung eines zu vernebelnden Medikaments ⤷  Sign Up
United Kingdom 0321612 ⤷  Sign Up
Cyprus 1111555 ⤷  Sign Up
European Patent Office 2062608 Ampoule unidirectionnelle pour un dispositif de production d'aérosols (Single use ampoule for a device to create aerosols) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for glycopyrrolate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435025 2019C/532 Belgium ⤷  Sign Up 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 ⤷  Sign Up 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 2021C/518 Belgium ⤷  Sign Up 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 ⤷  Sign Up 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 ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.