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Last Updated: May 20, 2022

Glycopyrrolate - Generic Drug Details


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

Glycopyrrolate is the generic ingredient in nine branded drugs 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, Hikma, Robins Ah, Novartis, Sunovion Resp, Exela Pharma, Merz Pharms, Par Pharm Inc, Edenbridge Pharms, Alembic Labs, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Lgm Pharma, Natco, Oxford Pharms, Par Pharm, Renata, Rising, Sun Pharm Inds Ltd, and Casper Pharma Llc, and is included in fifty-two NDAs. There are eighteen 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 eighty-two patent family members in thirty-two countries.

There are seventeen drug master file entries for glycopyrrolate. Forty-three suppliers are listed for this compound. There is one tentative approval 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
Emory UniversityPhase 4
Kangbuk Samsung HospitalN/A
SMG-SNU Boramae Medical CenterN/A

See all glycopyrrolate clinical trials

Generic filers with tentative approvals for GLYCOPYRROLATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1MG/5MLSOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Caplin GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 211705-001 Mar 20, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sunovion Resp LONHALA MAGNAIR KIT glycopyrrolate SOLUTION;INHALATION 208437-001 Dec 5, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Exela Pharma GLYRX-PF glycopyrrolate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 210997-003 Apr 9, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sunovion Resp LONHALA MAGNAIR KIT glycopyrrolate SOLUTION;INHALATION 208437-001 Dec 5, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Meitheal GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 212802-001 Jul 6, 2021 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kenton GLYCOPYRROLATE glycopyrrolate TABLET;ORAL 091182-001 Feb 3, 2014 AA RX 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

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 See Plans and Pricing See Plans and Pricing
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 See Plans and Pricing See Plans and Pricing
Sunovion Resp LONHALA MAGNAIR KIT glycopyrrolate SOLUTION;INHALATION 208437-001 Dec 5, 2017 See Plans and Pricing See Plans and Pricing
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 See Plans and Pricing See Plans and Pricing
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 See Plans and Pricing See Plans and Pricing
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for glycopyrrolate

Country Patent Number Title Estimated Expiration
Norway 20065718 See Plans and Pricing
European Patent Office 1663164 PROCEDES DE PREPARATION DE COMPOSITIONS PHARMACEUTIQUES (METHODS FOR PREPARING PHARMACEUTICAL COMPOSITIONS) See Plans and Pricing
United Kingdom 201008994 See Plans and Pricing
European Patent Office 1613323 COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE L'APOMORPHINE POUR L'INHALATION PULMONAIRE (PHARMACEUTICAL COMPOSITIONS COMPRISING APOMORHINE FOR PULMONARY INHALATION) See Plans and Pricing
China 1882318 Dry powder composition comprising co-jet milled particles for pulmonary inhalation See Plans and Pricing
Singapore 146648 PHARMACEUTICAL COMPOSITIONS FOR TREATING PREMATURE EJACULATION BY PULMONARY INHALATION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for glycopyrrolate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 2021C/518 Belgium See Plans and Pricing 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 LUC00124 Luxembourg See Plans and Pricing 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 See Plans and Pricing 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
2435025 19C1040 France See Plans and Pricing 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 2019C/532 Belgium See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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