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FDA Orange Book · active-ingredient family

Alogliptin benzoate; pioglitazone hydrochloride

Alogliptin benzoate; pioglitazone hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:OSENI · NDA 022426

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
OSENIRLD×6TAKEDA PHARMS USANDA 022426Jan 25, 2013

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7807689Jun 27, 2028in 2 yr 1 mo
SubstanceProductU-1337
8637079Jun 04, 2029in 3 yr
Product

Alogliptin benzoate; pioglitazone hydrochloride — 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.