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GLYCOPYRROLATE Drug Profile
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When do Glycopyrrolate patents expire, and what generic alternatives are available?
Glycopyrrolate is a drug marketed by Abraxis Pharm, Am Regent, Amneal, Apotex, Aurobindo Pharma Ltd, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Piramal Critical, Prinston Inc, Riconpharma Llc, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Natco Pharma Ltd, Nexgen Pharma, Orit Labs Llc, Oxford Pharms, Par Pharm, Renata, Rising, and Sun Pharm Inds Ltd. and is included in thirty-seven NDAs.
The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
US ANDA 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
Recent Clinical Trials for GLYCOPYRROLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rajesh Deshar | N/A |
| King Saud University | Phase 4 |
| Wonkwang University Hospital | Phase 4 |
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 | NDA | Submissiondate |
|---|---|---|---|---|
| CUVPOSA | SOLUTION;ORAL | glycopyrrolate | 022571 | 2012-06-20 |
| ROBINUL FORTE | TABLET;ORAL | glycopyrrolate | 012827 | 2010-10-12 |
| ROBINUL | TABLET;ORAL | glycopyrrolate | 012827 | 2010-10-12 |
| ROBINUL FORTE | TABLET;ORAL | glycopyrrolate | 012827 | 2009-08-14 |
| ROBINUL | TABLET;ORAL | glycopyrrolate | 012827 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Renata | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 040568-002 | Dec 22, 2004 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Natco Pharma Ltd | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 091413-002 | Jun 20, 2016 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Watson Labs | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 086178-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sun Pharm Inds Ltd | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 040844-002 | Aug 18, 2009 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
