GLYCOPYRROLATE Drug Patent Profile
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Which patents cover Glycopyrrolate, and when can generic versions of Glycopyrrolate launch?
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, Piramal Critical, Prinston Inc, Sagent, Sandoz, Somerset Theraps Llc, Teva Parenteral, Umedica, Watson Labs, Xiromed, Zydus Pharms, Annora Pharma, Par Pharm Inc, Suven 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, 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.
Summary for GLYCOPYRROLATE
US Patents: | 0 |
Applicants: | 42 |
NDAs: | 51 |
Finished Product Suppliers / Packagers: | 48 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 153 |
Patent Applications: | 3,925 |
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 |
---|---|
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 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 |