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Last Updated: December 12, 2025

Claims for Patent: 12,128,137

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Summary for Patent: 12,128,137

Title:	Topical compositions and methods for treating skin diseases
Abstract:	Topical pharmaceutical compositions include tazarotene or a pharmaceutically acceptable salt of tazarotenic acid and an oil-in-water emulsion vehicle that forms a lotion. The compositions are used to treat skin diseases, such as acne vulgaris.
Inventor(s):	Arturo Angel, Radhakrishnan Pillai
Assignee:	Bausch Health Ireland Ltd
Application Number:	US17/719,278
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,128,137
Patent Claims:	1. A method of treating acne vulgaris, the method comprising topically applying a pharmaceutical composition to an affected area of a body of a subject suffering from acne vulgaris, wherein the composition consists essentially of: tazarotene or a pharmaceutically acceptable tazarotenic acid salt present in the composition at a concentration of about 0.045 percent by weight of the composition; a liquid oil component; and an aqueous component; wherein said composition is an oil-in-water emulsion and is formulated as a lotion, and wherein the tazarotene or tazarotenic acid salt is dissolved in the liquid oil component. 2. The method of claim 1, wherein said aqueous component comprises water, a carbomer homopolymer, and a polymeric emulsifier; and wherein said oil component comprises a dicarboxylic acid ester, a monocarboxylic acid ester, or a combination thereof. 3. The method of claim 2, wherein the oil component comprises a dicarboxylic acid ester. 4. The method of claim 2, wherein the oil component further comprises mineral oil or light mineral oil. 5. The method of claim 4, wherein the oil component comprises diethyl sebacate and light mineral oil. 6. The method of claim 4, wherein the oil component of the emulsion consists of diethyl sebacate and mineral oil. 7. The method of claim 1, wherein said applying is carried out once per day for at least eight weeks. 8. The method of claim 1, wherein said applying is carried out once per day for at least twelve weeks. 9. The method of claim 1, wherein said applying is carried out once per day for twelve weeks. 10. The method of claim 1, wherein the composition has a pH of about 4 to about 6. 11. A pharmaceutical composition for treating acne vulgaris, the composition consisting essentially of: tazarotene or a pharmaceutically acceptable tazarotenic acid salt present in the composition at a concentration of 0.045 percent by weight of the composition; a liquid oil component; and an aqueous component; wherein said composition is an oil-in-water emulsion and is formulated as a lotion, and wherein the tazarotene or tazarotenic acid salt is dissolved in the liquid oil component.

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