GLYCOPYRROLATE Drug Patent Profile
✉ Email this page to a colleague
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, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Lupin Ltd, Mankind Pharma, Meitheal, Omnivium Pharms, Piramal Critical, Prinston Inc, Sagent, Sandoz, Somerset Theraps Llc, Teva Parenteral, Umedica, Watson Labs, Xiromed, Zydus Pharms, Annora Pharma, Chartwell Rx, Endo Operations, Granules, Saptalis Pharms, Suven Pharms, Adaptis, Aurobindo Pharma, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Lgm Pharma, Natco, Oxford Pharms, Quagen, Rising, Sun Pharm Inds Ltd, and Velzen Pharma Pvt. and is included in fifty-five NDAs.
The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-six 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for GLYCOPYRROLATE?
- What are the global sales for GLYCOPYRROLATE?
- What is Average Wholesale Price for GLYCOPYRROLATE?
Summary for GLYCOPYRROLATE
| US Patents: | 0 |
| Applicants: | 44 |
| NDAs: | 55 |
| Finished Product Suppliers / Packagers: | 50 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 156 |
| Patent Applications: | 3,886 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 202675-002 | Oct 30, 2018 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Endo Operations | GLYCOPYRROLATE | glycopyrrolate | SOLUTION;ORAL | 204438-001 | Aug 9, 2021 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Heritage Pharms Inc | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 207201-002 | Jan 3, 2017 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 040821-002 | Dec 29, 2008 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys Labs Ltd | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 040847-002 | Mar 21, 2008 | AA | RX | 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 | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
