GLYCOPYRROLATE Drug Patent Profile
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When do Glycopyrrolate patents expire, and what generic alternatives are available?
Glycopyrrolate is a drug 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, Nivagen Pharms Inc, Piramal Critical, Prinston Inc, Sagent, Sandoz, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Xiromed, Zydus Pharms, Annora Pharma, Endo Operations, Suven Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Indoco, Leading, Lgm Pharma, Natco, Oxford Pharms, Rising, and Sun Pharm Inds Ltd. and is included in fifty-one NDAs.
The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Glycopyrrolate
A generic version of GLYCOPYRROLATE was approved as glycopyrrolate by AM REGENT on July 23rd, 1986.
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Summary for GLYCOPYRROLATE
US Patents: | 0 |
Applicants: | 41 |
NDAs: | 51 |
Finished Product Suppliers / Packagers: | 49 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 156 |
Patent Applications: | 4,571 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
---|---|
University of California, Irvine | Phase 4 |
Clayton Petro | Phase 4 |
Jie Chen | Phase 1/Phase 2 |
Pharmacology for GLYCOPYRROLATE
Drug Class | Anticholinergic Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Endo Operations | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 040653-001 | Aug 31, 2006 | AA | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Suven Pharms | GLYCOPYRROLATE | glycopyrrolate | SOLUTION;ORAL | 212467-001 | Jul 5, 2022 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Leading | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 090195-001 | Sep 21, 2012 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Watson Labs | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 085562-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma Intl Pharms | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 040836-001 | Mar 5, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Leading | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 090195-002 | Sep 21, 2012 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Oxford Pharms | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 090020-002 | Oct 19, 2011 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |