ROBINUL FORTE Drug Patent Profile
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When do Robinul Forte patents expire, and when can generic versions of Robinul Forte launch?
Robinul Forte is a drug marketed by Casper Pharma Llc and is included in one NDA.
The generic ingredient in ROBINUL FORTE 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 Robinul Forte
A generic version of ROBINUL FORTE was approved as glycopyrrolate by AM REGENT on July 23rd, 1986.
Summary for ROBINUL FORTE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 6 |
| Patent Applications: | 3,883 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ROBINUL FORTE |
| DailyMed Link: | ROBINUL FORTE at DailyMed |
Recent Clinical Trials for ROBINUL FORTE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | N/A |
| McGill University Health Center | N/A |
| University of Oulu | Phase 4 |
Pharmacology for ROBINUL FORTE
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
Paragraph IV (Patent) Challenges for ROBINUL FORTE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| 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 ROBINUL FORTE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Casper Pharma Llc | ROBINUL FORTE | glycopyrrolate | TABLET;ORAL | 012827-002 | Approved Prior to Jan 1, 1982 | AA | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ROBINUL FORTE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Casper Pharma Llc | ROBINUL FORTE | glycopyrrolate | TABLET;ORAL | 012827-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
