Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

• Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
• Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
• As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N207999

Product 001
OBETICHOLIC ACID (OCALIVA) TABLET 5MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	9238673	06/17/2033		DP			06/22/2016
001	10047117	09/06/2033			U-1854		11/14/2018
001	10052337	04/26/2036		DP			11/08/2018
001	10174073	06/17/2033	DS				01/15/2019
001	10751349	04/26/2036		DP			08/28/2020
001	10758549	04/26/2036			U-2945		09/10/2020
001	RE48286	02/21/2027	DS	DP			10/28/2020

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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