Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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.

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
003	7888362	04/12/2026	DS			Y	07/23/2015
003	7888362*PED	10/12/2026
003	8349840	04/12/2026		DP	U-1529		07/23/2015
003	8349840*PED	10/12/2026
003	8618109	04/12/2026			U-543 U-3281		07/23/2015
003	8618109*PED	10/12/2026
003	9839637	04/12/2026		DP	U-543 U-1529 U-3281		01/09/2018
003	9839637*PED	10/12/2026
003	10307419	10/12/2032		DP			06/14/2019
003	10307419*PED	04/12/2033
003	RE48059	12/23/2028	DS				07/20/2020
003	RE48059*PED	06/23/2029