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: N204308

Product 001
ENALAPRIL MALEATE (EPANED KIT) FOR SOLUTION 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8568747	11/06/2032		DP			10/31/2013
001	8778366	11/06/2032			U-3 U-71 U-185 U-1723 U-1892		07/16/2014
001	9855214	11/06/2032		DP			01/10/2018
001	9968553	11/06/2032			U-3 U-71 U-185 U-1723 U-1892		06/01/2018

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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