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.
Summary for glycopyrrolate
International Patents: | 182 |
US Patents: | 18 |
Tradenames: | 9 |
Applicants: | 45 |
NDAs: | 52 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 43 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 144 |
Patent Applications: | 6,761 |
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 |
---|---|
Emory University | Phase 4 |
Kangbuk Samsung Hospital | N/A |
SMG-SNU Boramae Medical Center | N/A |
Generic filers with tentative approvals for GLYCOPYRROLATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 1MG/5ML | SOLUTION;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 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
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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