ZILXI Drug Patent Profile

When do Zilxi patents expire, and what generic alternatives are available?

Zilxi is a drug marketed by Journey and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in ten countries.

The generic ingredient in ZILXI is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zilxi

A generic version of ZILXI was approved as minocycline hydrochloride by WATSON LABS on December 30^th, 1991.

Summary for ZILXI

International Patents:	22
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Patent Applications:	2,826
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZILXI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZILXI
What excipients (inactive ingredients) are in ZILXI?	ZILXI excipients list
DailyMed Link:	ZILXI at DailyMed

See drug prices for ZILXI

Pharmacology for ZILXI

Drug Class	Tetracycline-class Drug
Physiological Effect	Decreased Prothrombin Activity

Anatomical Therapeutic Chemical (ATC) Classes for ZILXI

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ZILXI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZILXI	Topical Aerosol Foam	minocycline hydrochloride	1.50%	213690	1	2022-02-28

US Patents and Regulatory Information for ZILXI

ZILXI is protected by eight US patents.

Patents protecting ZILXI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes			Y
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes			Y
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes			Y
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes			Y
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes			Y
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes			Y

International Patents for ZILXI

See the table below for patents covering ZILXI around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112012007473	composições tópicas de tetraciclina e respectivo método de uso
World Intellectual Property Organization (WIPO)	2011138678
Canada	2776474	COMPOSITIONS DE TETRACYCLINE A USAGE TOPIQUE (TOPICAL TETRACYCLINE COMPOSITIONS)
Canada	2776366	COMPOSITIONS MOUSSANTES SANS EAU ET SANS SURFACTANT, MOUSSES ET GELS FRIABLES, AINSI QUE LEURS UTILISATIONS (SURFACTANT-FREE WATER-FREE FOAMABLE COMPOSITIONS, BREAKABLE FOAMS AND GELS AND THEIR USES)
Canada	2867419	UTILISATION DE COMPOSITIONS DE TETRACYCLINE POUR LE TRAITEMENT DES BLESSURES ET LA RESTAURATION DE LA PEAU (USE OF TETRACYCLINE COMPOSITIONS FOR WOUND TREATMENT AND SKIN RESTORATION)
World Intellectual Property Organization (WIPO)	2011064631