PHENTOLAMINE MESYLATE Drug Patent Profile
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When do Phentolamine Mesylate patents expire, and when can generic versions of Phentolamine Mesylate launch?
Phentolamine Mesylate is a drug marketed by Hikma and Precision Dose Inc and is included in two NDAs.
The generic ingredient in PHENTOLAMINE MESYLATE 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 Phentolamine Mesylate
A generic version of PHENTOLAMINE MESYLATE 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 PHENTOLAMINE MESYLATE?
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Summary for PHENTOLAMINE MESYLATE
Recent Clinical Trials for PHENTOLAMINE MESYLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alberta | Phase 4 |
| Cairo University | Phase 3 |
| University of Alberta | N/A |
Pharmacology for PHENTOLAMINE MESYLATE
| Drug Class | alpha-Adrenergic Blocker |
| Mechanism of Action | Adrenergic alpha-Antagonists |
Medical Subject Heading (MeSH) Categories for PHENTOLAMINE MESYLATE
Anatomical Therapeutic Chemical (ATC) Classes for PHENTOLAMINE MESYLATE
Paragraph IV (Patent) Challenges for PHENTOLAMINE MESYLATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| RYZUMVI | Ophthalmic Solution | phentolamine mesylate | 0.75% | 217064 | 1 | 2024-12-16 |
US Patents and Regulatory Information for PHENTOLAMINE MESYLATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | PHENTOLAMINE MESYLATE | phentolamine mesylate | INJECTABLE;INJECTION | 040235-001 | Mar 11, 1998 | AP | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Precision Dose Inc | PHENTOLAMINE MESYLATE | phentolamine mesylate | INJECTABLE;INJECTION | 207686-001 | Jul 14, 2017 | AP | RX | 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 |


