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: N212379

Product 001
MINOCYCLINE HYDROCHLORIDE (AMZEEQ) AEROSOL, FOAM EQ 4% BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8865139	10/01/2030		DP	U-2647		11/15/2019
001	8945516	10/01/2030		DP			11/15/2019
001	8992896	10/01/2030		DP	U-2647		11/15/2019
001	9675700	10/01/2030		DP	U-2647		11/15/2019
001	10086080	10/01/2030			U-2647		11/15/2019
001	10137200	10/01/2030			U-2647		11/15/2019
001	10213512	10/01/2030		DP	U-2647		11/15/2019
001	10265404	10/01/2030		DP			11/15/2019
001	10398641	09/08/2037			U-2647		11/15/2019
001	10517882	10/01/2030			U-2647		01/10/2020
001	10821187	10/01/2030			U-2647		11/16/2020
001	10849847	09/08/2037			U-2647		12/09/2020

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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