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FDA Orange Book · active-ingredient family

Omacetaxine mepesuccinate

Omacetaxine mepesuccinate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SYNRIBO · NDA 203585

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · powder

ProductApplicantApplicationTEApproved
SYNRIBORLDTEVA PHARMS INTLNDA 203585Oct 26, 2012

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
6987103Oct 26, 2026in 4 mo
U-1300

Omacetaxine mepesuccinate — 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.