REGITINE Drug Patent Profile
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 is one drug master file entry for this compound. Four 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.
AI Deep Research
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: | 48 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,698 |
| DailyMed Link: | REGITINE at DailyMed |
Recent Clinical Trials for REGITINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Pennsylvania | Early Phase 1 |
| National Institutes of Health (NIH) | Early Phase 1 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 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 | ⤷ 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 |
