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 ten branded drugs marketed by Abraxis Pharm, Accord Hlthcare, Alembic, Am Regent, Amneal, Apotex, Aspen, Athenex Inc, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Lupin Ltd, Mankind Pharma, Meitheal, Nivagen Pharms Inc, Piramal Critical, Prinston Inc, Sandoz, Somerset Theraps Llc, Teva Parenteral, 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, Kenton, 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 nineteen 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-eight suppliers are listed for this compound.
Summary for glycopyrrolate
International Patents: | 175 |
US Patents: | 19 |
Tradenames: | 10 |
Applicants: | 51 |
NDAs: | 61 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 58 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 153 |
Patent Applications: | 6,853 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for glycopyrrolate |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for glycopyrrolate |
What excipients (inactive ingredients) are in glycopyrrolate? | glycopyrrolate excipients list |
DailyMed Link: | glycopyrrolate at DailyMed |
Recent Clinical Trials for glycopyrrolate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Trauma Center | N/A |
Merck Sharp & Dohme LLC | Phase 4 |
Ciusss de L'Est de l'Île de Montréal | N/A |
Pharmacology for glycopyrrolate
Drug Class | Anticholinergic |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amneal | GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 215333-001 | Oct 21, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Watson Labs | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 086178-001 | Approved Prior to Jan 1, 1982 | DISCN | 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 | |||
Oxford Pharms | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 090020-002 | Oct 19, 2011 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Lgm Pharma | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 091522-001 | Mar 12, 2012 | 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 |
---|---|---|---|---|---|---|---|
Novartis | SEEBRI | glycopyrrolate | POWDER;INHALATION | 207923-001 | Oct 29, 2015 | ⤷ 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 |
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 | 2895136 | ÉLÉMENT D'OUVERTURE POUR OUVRIR UNE AMPOULE DANS UN DISPOSITIF DE GÉNÉRATION D'AÉROSOL ET DISPOSITIF DE GÉNÉRATION D'AÉROSOL COMPRENANT L'ÉLÉMENT D'OUVERTURE (OPENING ELEMENT FOR OPENING AN AMPOULE IN AN AEROSOL GENERATION DEVICE AND AEROSOL GENERATION DEVICE COMPRISING THE OPENING ELEMENT) | ⤷ Try a Trial |
Argentina | 051353 | INHALADOR PARA MEDICAMENTOS EN POLVO. | ⤷ Try a Trial |
China | 100569238 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2005113042 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2009134524 | ⤷ 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 |
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 |
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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