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FDA Orange Book · active-ingredient family

Obeticholic acid

Obeticholic acid is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:OCALIVA · NDA 207999

1

Brand (NDA)

3

Generics (ANDA)

7

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
OCALIVARLD×2INTERCEPTNDA 207999—May 27, 2016

Generic (ANDA) products (3)

ProductApplicantApplicationTEApproved
OBETICHOLIC ACID×2APOTEXANDA 214862—May 30, 2023
OBETICHOLIC ACID×2LUPINANDA 214980—May 30, 2023
OBETICHOLIC ACID×2MSNANDA 215017—May 30, 2023

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
RE48286Feb 21, 2027in 8 mo
SubstanceProduct
10174073Jun 17, 2033in 7 yr 1 mo
Substance
9238673Jun 17, 2033in 7 yr 1 mo
Product
10047117Sep 06, 2033in 7 yr 4 mo
U-1854
10758549Apr 26, 2036in 10 yr
U-2945
10751349Apr 26, 2036in 10 yr
Product
10052337Apr 26, 2036in 10 yr
Product

Obeticholic acid — frequently asked questions

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

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