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Last Updated: March 29, 2024

Glycopyrrolate - Generic Drug Details


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What are the generic sources for glycopyrrolate and what is the scope of freedom to operate?

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

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

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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
Hikma Farmaceutica GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 090963-001 Sep 21, 2011 AP RX No Yes ⤷  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
Piramal Critical GLYCOPYRROLATE glycopyrrolate INJECTABLE;INJECTION 210842-001 Oct 25, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
>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
>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 3331650 PROCÉDÉ DE FABRICATION D'UNE TÊTE SUSCEPTIBLE DE VIBRER POUR UN GÉNÉRATEUR D'AÉROSOL ET TÊTE SUSCEPTIBLE DE VIBRER POUR UN GÉNÉRATEUR D'AÉROSOL (METHOD OF MANUFACTURING A VIBRATABLE HEAD FOR AN AEROSOL GENERATOR AND VIBRATABLE HEAD FOR AN AEROSOL GENERATOR) ⤷  Try a Trial
European Patent Office 2257172 PROCÉDÉ ET SYSTÈME PERMETTANT DE TRAITER LA BRONCHOPNEUMOPATHIE CHRONIQUE OBSTRUCTIVE AU MOYEN D'ADMINISTRATIONS D'ANTICHOLINERGIQUES PAR NÉBULISATION (METHOD AND SYSTEM FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH NEBULIZED ANTICHOLINERGIC ADMINISTRATIONS) ⤷  Try a Trial
South Korea 101170187 ⤷  Try a Trial
Brazil PI0805219 ampola descartável para uso em um dispositivo gerador de aerossol ⤷  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 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 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
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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