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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, Accord Hlthcare, 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, Alembic Labs, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Lgm Pharma, Natco Pharma Ltd, Oxford Pharms, Par Pharm, Renata, Rising, and Sun Pharm Inds Ltd. and is included in thirty-eight NDAs.
The generic ingredient in GLYCOPYRROLATE is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty-three 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
| US Patents: | 0 |
| Applicants: | 32 |
| NDAs: | 38 |
| Suppliers / Packagers: | 37 |
| Bulk Api Vendors: | 87 |
| Clinical Trials: | 133 |
| Patent Applications: | 2,592 |
| 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 |
|---|---|
| Temple University | Phase 4 |
| Tanta University | Phase 1 |
| Rajesh Deshar | N/A |
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 | TABLET;ORAL | glycopyrrolate | 012827 | 2010-10-12 |
| ROBINUL FORTE | 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 | 040568-001 | Dec 22, 2004 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Leading Pharma Llc | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 090195-001 | Sep 21, 2012 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Watson Labs | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 085563-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sun Pharm Inds Ltd | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 040844-001 | Aug 18, 2009 | 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 | ||||
| Hikma Intl Pharms | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 040836-001 | Mar 5, 2009 | DISCN | 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 |
