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Last Updated: March 29, 2024

Claims for Patent: 10,398,641


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Summary for Patent: 10,398,641
Title:Compositions and methods for treating rosacea and acne
Abstract: Provided are compositions and methods for treating rosacea and acne. Specifically, a gel or foam composition having a tetracycline antibiotic and uses thereof for treating rosacea and acne are provided.
Inventor(s): Tamarkin; Dov (Ness Ziona, IL), Eini; Meir (Ness Ziona, IL), Hazot; Yohan (Rehovot, IL), Shirvan; Mitchell (Kfar Saba, IL), Kedem; Tal Hetzroni (Rehovot, IL), Keynan; Rita (Rehovot, IL)
Assignee: Foamix Pharmaceuticals Ltd. (Rehovot, IL)
Application Number:15/699,692
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,398,641
Patent Claims: 1. A method for treating acne vulgaris in a subject in need thereof, comprising topically administering to the subject a therapeutically effective amount of a breakable foam obtained from a foamable composition once daily for at least seven consecutive days, wherein the foamable composition comprises: (a) a hydrophobic vehicle comprising: (i) about 70% to about 90% by weight of a hydrophobic solvent comprising: about 50% w/w of soybean oil; about 16.5% w/w to about 30.7% w/w of coconut oil; about 3.5% w/w to about 6.5% w/w of cyclomethicone; and about 1% w/w to about 6% w/w of light mineral oil; and (ii) about 10% to about 22% by weight of a foamer complex comprising: about 3.5% w/w of cetostearyl alcohol; about 2% w/w to about 4% w/w of stearic acid; about 1.8% w/w to about 3.3% w/w of myristyl alcohol; about 1% w/w to about 3% w/w of hydrogenated castor oil; about 1% w/w to about 3% w/w of beeswax; about 1% w/w to about 2% w/w of stearyl alcohol; and about 0.5% w/w to about 1.5% w/w of behenyl alcohol; (iii) minocycline in an amount ranging from about 1% w/w to about 4% w/w; and (b) a propellant in an amount ranging from about 3% to about 25% w/w; and wherein the foamable composition does not comprises silicon dioxide (SiO.sub.2), wherein seven days of topical treatment with the breakable foam at the therapeutically effective amount results in a maximum concentration of minocycline in plasma from the subject of about 2 ng/mL, as measured during a 24 hour period following the last topical administration, and wherein the subject is between 15 years old and 16 years and 11 months old.

2. The method of claim 1, wherein seven days of topical treatment with the therapeutically effective amount results in a concentration of minocycline in plasma from the subjects of about 1.4 ng/mL to about 3.7 ng/mL, as measured 24 hours after the last topical administration.

3. The method of claim 1, wherein the area under a concentration-time curve of the amount of the minocycline in the plasma of the subjects is determined during a 24 hour period following the last topical administration.

4. The method of claim 3, wherein the area under the concentration-time curve of the minocycline in the plasma is about 40.8 ng/mL*hour.

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