FDA Orange Book
Is there a generic for Ryzumvi?
Ryzumvi contains phentolamine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ryzumvi (phentolamine). The Orange Book shows its last listed patent expires October 25, 2039 and its last listed exclusivity ends September 25, 2026.
Run it in Rivvi
Map Ryzumvi and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Ryzumvi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, ophthalmic | EQ 0.75% BASE | Marketed (Rx) | None | 0 | None |
NDA 217064, held by FAMYGEN LIFE SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ryzumvi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12734126 | January 31, 2034 | Method of use | U-4604 | 217064 |
| 12350366 | January 31, 2034 | Drug product | None | 217064 |
| 11844858 | January 31, 2034 | Drug product | None | 217064 |
| 9795560 | January 31, 2034 | Drug product | None | 217064 |
| 11090261 | January 31, 2034 | Drug product | None | 217064 |
| 10278918 | January 31, 2034 | Drug product | None | 217064 |
| 10772829 | January 31, 2034 | Drug product | None | 217064 |
| 12721810 | January 31, 2034 | Drug product | None | 217064 |
| 12201616 | October 25, 2039 | Method of use | U-3804 | 217064 |
| 12201615 | October 25, 2039 | Method of use | U-3804 | 217064 |
| 11400077 | October 25, 2039 | Method of use | U-3804 | 217064 |
| 12576067 | October 25, 2039 | Method of use | U-3804 | 217064 |
| 12576066 | October 25, 2039 | Method of use | U-3804 | 217064 |
Ryzumvi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | September 25, 2026 | 217064 |
Ryzumvi NDC codes
Questions
Is there a generic for Ryzumvi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ryzumvi (phentolamine). The Orange Book shows its last listed patent expires October 25, 2039 and its last listed exclusivity ends September 25, 2026.
What is the generic name for Ryzumvi?
The active ingredient in Ryzumvi is phentolamine, per the FDA Orange Book.
When does the Ryzumvi patent expire?
The last patent listed for Ryzumvi in the Orange Book expires October 25, 2039. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.