RYZUMVI Drug Patent Profile
Which patents cover Ryzumvi, and when can generic versions of Ryzumvi launch?
Ryzumvi is a drug marketed by Famygen Life Sci and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in RYZUMVI 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 Ryzumvi
A generic version of RYZUMVI was approved as phentolamine mesylate by HIKMA on March 11th, 1998.
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Summary for RYZUMVI
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 1,267 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RYZUMVI |
| What excipients (inactive ingredients) are in RYZUMVI? | RYZUMVI excipients list |
| DailyMed Link: | RYZUMVI at DailyMed |
Pharmacology for RYZUMVI
| Drug Class | alpha-Adrenergic Blocker |
| Mechanism of Action | Adrenergic alpha-Antagonists |
Paragraph IV (Patent) Challenges for RYZUMVI
| 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 RYZUMVI
RYZUMVI is protected by thirteen US patents and one FDA Regulatory Exclusivity.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Famygen Life Sci | RYZUMVI | phentolamine mesylate | SOLUTION;OPHTHALMIC | 217064-001 | Sep 25, 2023 | RX | Yes | Yes | 12,201,616 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Famygen Life Sci | RYZUMVI | phentolamine mesylate | SOLUTION;OPHTHALMIC | 217064-001 | Sep 25, 2023 | RX | Yes | Yes | 12,350,366 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Famygen Life Sci | RYZUMVI | phentolamine mesylate | SOLUTION;OPHTHALMIC | 217064-001 | Sep 25, 2023 | RX | Yes | Yes | 12,734,126 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Famygen Life Sci | RYZUMVI | phentolamine mesylate | SOLUTION;OPHTHALMIC | 217064-001 | Sep 25, 2023 | RX | Yes | Yes | 10,772,829 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Famygen Life Sci | RYZUMVI | phentolamine mesylate | SOLUTION;OPHTHALMIC | 217064-001 | Sep 25, 2023 | RX | Yes | Yes | 11,844,858 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Famygen Life Sci | RYZUMVI | phentolamine mesylate | SOLUTION;OPHTHALMIC | 217064-001 | Sep 25, 2023 | RX | Yes | Yes | ⤷ 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 |
International Patents for RYZUMVI
See the table below for patents covering RYZUMVI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2014212274 | Aqueous ophthalmic solutions of phentolamine and medical uses thereof | ⤷ Start Trial |
| Australia | 2018200566 | AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF | ⤷ Start Trial |
| Canada | 2899339 | SOLUTIONS OPHTALMIQUES AQUEUSES DE PHENTOLAMINE ET UTILISATIONS MEDICALES ASSOCIEES (AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF) | ⤷ Start Trial |
| Denmark | 2950648 | ⤷ Start Trial | |
| European Patent Office | 2950648 | SOLUTIONS OPHTALMIQUES AQUEUSES DE PHENTOLAMINE ET UTILISATIONS MÉDICALES ASSOCIÉES (AQUEOUS OPHTHALMIC SOLUTIONS OF PHENTOLAMINE AND MEDICAL USES THEREOF) | ⤷ Start Trial |
| Spain | 2762153 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |

