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ROBINUL Drug Profile
» See Plans and Pricing
Which patents cover Robinul, and when can generic versions of Robinul launch?
Robinul is a drug marketed by Hikma, Robins Ah, and Casper Pharma Llc. and is included in three NDAs.
The generic ingredient in ROBINUL is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
US ANDA Litigation and Generic Entry Outlook for Robinul
A generic version of ROBINUL was approved as glycopyrrolate by AM REGENT on July 23rd, 1986.
Summary for ROBINUL
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 87 |
| Clinical Trials: | 4 |
| Patent Applications: | 2,592 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ROBINUL |
| What excipients (inactive ingredients) are in ROBINUL? | ROBINUL excipients list |
| DailyMed Link: | ROBINUL at DailyMed |
Recent Clinical Trials for ROBINUL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McGill University Health Center | N/A |
| University of Oulu | Phase 4 |
| Oulu University Hospital | Phase 4 |
Pharmacology for ROBINUL
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
Paragraph IV (Patent) Challenges for ROBINUL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ROBINUL FORTE | TABLET;ORAL | glycopyrrolate | 012827 | 2010-10-12 |
| ROBINUL | TABLET;ORAL | glycopyrrolate | 012827 | 2010-10-12 |
| ROBINUL | TABLET;ORAL | glycopyrrolate | 012827 | 2009-08-14 |
| ROBINUL FORTE | TABLET;ORAL | glycopyrrolate | 012827 | 2009-08-14 |
US Patents and Regulatory Information for ROBINUL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | ROBINUL | glycopyrrolate | INJECTABLE;INJECTION | 017558-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Casper Pharma Llc | ROBINUL FORTE | glycopyrrolate | TABLET;ORAL | 012827-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Robins Ah | ROBINUL | glycopyrrolate | INJECTABLE;INJECTION | 014764-001 | Approved Prior to Jan 1, 1982 | 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 |
