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FDA Orange Book · active-ingredient family

Panobinostat lactate

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

Reference-listed drug:FARYDAK · NDA 205353

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
FARYDAKRLD×3SECURANDA 205353—Feb 23, 2015

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7989494Jan 17, 2028in 1 yr 7 mo
SubstanceProduct
8883842Jun 13, 2028in 2 yr
U-1669

Panobinostat lactate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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