FDA Orange Book · active-ingredient family
Bremelanotide acetate
Bremelanotide acetate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VYLEESI (AUTOINJECTOR) · NDA 210557
1
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VYLEESI (AUTOINJECTOR)RLD | COSETTE | NDA 210557 | — | Jun 21, 2019 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9352013 | Nov 05, 2033 | in 7 yr 6 mo | U-2568 |
| 9700592 | Nov 05, 2033 | in 7 yr 6 mo | U-2568 |
| 10286034 | Nov 05, 2033 | in 7 yr 6 mo | U-2568 |
| 11590209 | Apr 29, 2041 | in 15 yr 1 mo | U-3539 |
Bremelanotide acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
