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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

ProductApplicantApplicationTEApproved
OMONTYS×8TAKEDA PHARMS USANDA 202799Mar 27, 2012

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7550433Jun 02, 202617 d ago
U-1238
7919461Jun 02, 202617 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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.