FDA Orange Book · active-ingredient family
Peginesatide acetate
Peginesatide acetate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:OMONTYS · NDA 202799
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OMONTYS×8 | TAKEDA PHARMS USA | NDA 202799 | — | Mar 27, 2012 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7550433 | Jun 02, 2026 | 17 d ago | U-1238 |
| 7919461 | Jun 02, 2026 | 17 d ago | U-1238 |
Peginesatide acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

