REGITINE Drug Patent Profile
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When do Regitine patents expire, and when can generic versions of Regitine launch?
Regitine is a drug marketed by Novartis and is included in one NDA.
The generic ingredient in REGITINE is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Regitine
A generic version of REGITINE was approved as phentolamine mesylate by HIKMA on March 11th, 1998.
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Questions you can ask:
- What is the 5 year forecast for REGITINE?
- What are the global sales for REGITINE?
- What is Average Wholesale Price for REGITINE?
Summary for REGITINE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 2 |
| Patent Applications: | 3,808 |
| DailyMed Link: | REGITINE at DailyMed |
Recent Clinical Trials for REGITINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institutes of Health (NIH) | Early Phase 1 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Early Phase 1 |
| University of Pennsylvania | Early Phase 1 |
US Patents and Regulatory Information for REGITINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | REGITINE | phentolamine mesylate | INJECTABLE;INJECTION | 008278-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
