FDA Orange Book
Is there a generic for Vyleesi (autoinjector)?
Vyleesi (autoinjector) contains bremelanotide acetate. 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 Vyleesi (autoinjector) (bremelanotide acetate). The Orange Book shows its last listed patent expires April 29, 2041.
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Vyleesi (autoinjector) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) | Marketed (Rx) | None | 0 | None |
NDA 210557, held by COSETTE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vyleesi (autoinjector) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9352013 | November 5, 2033 | Method of use | U-2568 | 210557 |
| 9700592 | November 5, 2033 | Method of use | U-2568 | 210557 |
| 10286034 | November 5, 2033 | Method of use | U-2568 | 210557 |
| 11590209 | April 29, 2041 | Method of use | U-3539 | 210557 |
Vyleesi (autoinjector) NDC codes
Questions
Is there a generic for Vyleesi (autoinjector)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vyleesi (autoinjector) (bremelanotide acetate). The Orange Book shows its last listed patent expires April 29, 2041.
What is the generic name for Vyleesi (autoinjector)?
The active ingredient in Vyleesi (autoinjector) is bremelanotide acetate, per the FDA Orange Book.
When does the Vyleesi (autoinjector) patent expire?
The last patent listed for Vyleesi (autoinjector) in the Orange Book expires April 29, 2041. 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.