Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

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: N202107

Product 001
MIFEPRISTONE (KORLYM) TABLET 300MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8921348	08/27/2028			U-1643		01/27/2015
001	9829495	08/15/2036			U-1643		11/28/2017
001	9943526	04/20/2036			U-1643		04/17/2018
001	10006924	08/12/2036			U-1643		07/10/2018
001	10151763	01/18/2037			U-1643		12/12/2018
001	10166242	04/20/2036			U-1643		01/02/2019
001	10166243	04/20/2036			U-1643		01/02/2019
001	10195214	06/19/2037			U-1643		02/05/2019
001	10231983	08/22/2038			U-1643		04/03/2019
001	10314850	08/22/2038			U-1643		06/14/2019
001	10495650	08/12/2036			U-1643		12/03/2019
001	10500216	03/05/2033			U-1643		12/10/2019
001	10660904	04/20/2036			U-1643		05/29/2020
001	10780097	08/22/2038			U-1643		09/24/2020
001	10842800	06/19/2037			U-1643		11/24/2020
001	10842801	11/15/2032			U-1643		11/24/2020

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

View a list of all patent use codes
View a list of all exclusivity codes