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Last Updated: January 29, 2022

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Claims for Patent: 10,206,939


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Summary for Patent: 10,206,939
Title:Treatment of papulopustular rosacea with ivermectin
Abstract: Methods and compositions for safe and effective treatment of papulopustular rosacea in a subject are described. The methods involve topically applying to an affected skin area a topical composition containing ivermectin and a pharmaceutically acceptable carrier. Treatment with ivermectin represents an innovative therapy that is more robust and effective than the conventional treatments.
Inventor(s): Jacovella; Jean (Antibes, FR), Chappuis; Jean-Paul (Valbonne, FR), Kaoukhov; Alexandre (Newport Beach, CA), Graeber; Michael (Lawrenceville, NJ), Poncet; Michel (Mougins, FR), Briantais; Philippe (Antibes, FR), Salin; Laurence (La Roquette sur Siagne, FR)
Assignee: Galderma S.A. (Cham, CH)
Application Number:15/988,368
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,206,939
Patent Claims: 1. A method of treating papulopustular rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the papulopustular rosacea a therapeutically effective amount of a pharmaceutical composition comprising ivermectin and a pharmaceutically acceptable carrier without co-administration of another active pharmaceutical ingredient, wherein the pharmaceutical composition comprises 0.5% to 1% by weight ivermectin, and a reduction in inflammatory lesion count in the subject is observed 2 weeks after the initial administration of the pharmaceutical composition.

2. The method of claim 1, wherein the subject has moderate to severe papulopustular rosacea before the treatment.

3. The method of claim 1, wherein the subject has 15 or more inflammatory lesions of the papulopustular rosacea before the treatment.

4. The method of claim 1, wherein the subject is treated once daily for 12 weeks or more.

5. The method of claim 1, wherein at least about 27.3% reduction of inflammatory lesion counts in the subject is observed by 2 weeks after the initial administration of the pharmaceutical composition.

6. The method of claim 5, wherein the pharmaceutical composition comprises about 1% by weight ivermectin.

7. The method of claim 1, wherein the pharmaceutical composition further comprises one or more ingredients selected from the group consisting of: an oily phase comprising dimethicone, cyclomethicone, isopropyl palmitate and/or isopropyl myristate, the oily phase further comprising fatty substances selected from the group consisting of cetyl alcohol, cetostearyl alcohol, stearyl alcohol, palmitostearic acid, stearic acid and self-emulsifiable wax; at least one surfactant-emulsifier selected from the group consisting of glyceryl/PEG100 stearate, sorbitan monostearate, sorbitan palmitate, Steareth-20, Steareth-2, Steareth-21 and Ceteareth-20; a mixture of solvents and/or propenetrating agents selected from the group consisting of propylene glycol, oleyl alcohol, phenoxyethanol and glyceryl triacetate; one or more gelling agents selected from the group consisting of carbomers, cellulose gelling agents, xanthan gums, aluminum magnesium silicates but excluding aluminum magnesium silicate/titanium dioxide/silica, guar gums, polyacrylamides and modified starches; and water.

8. The method of claim 1, wherein the subject has no adverse reaction, and the adverse reaction is skin burning sensation or skin irritation.

9. The method of claim 4, wherein the subject has no adverse reaction, and the adverse reaction is skin burning sensation or skin irritation.

10. A method of treating inflammatory lesions of rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the inflammatory lesions of rosacea a pharmaceutical composition comprising ivermectin and a pharmaceutically acceptable carrier, without co-administration of another active pharmaceutical ingredient, wherein the pharmaceutical composition comprises 1% by weight ivermectin, wherein a reduction in inflammatory lesion count in the subject is observed 2 weeks after the initial administration of the pharmaceutical composition.

11. The method of claim 10, wherein the subject has moderate to severe papulopustular rosacea before the treatment.

12. The method of claim 10, wherein the subject has 15 or more of the inflammatory lesions before the treatment.

13. The method of claim 10, wherein the subject is treated once daily for 12 weeks or more.

14. The method of claim 13, wherein at least about 27.3% reduction of inflammatory lesion counts in the subject is observed by 2 weeks after the initial administration of the pharmaceutical composition.

15. The method of claim 10, wherein the pharmaceutical composition further comprises one or more ingredients selected from the group consisting of: an oily phase comprising dimethicone, cyclomethicone, isopropyl palmitate and/or isopropyl myristate, the oily phase further comprising fatty substances selected from the group consisting of cetyl alcohol, cetostearyl alcohol, stearyl alcohol, palmitostearic acid, stearic acid and self-emulsifiable wax; at least one surfactant-emulsifier selected from the group consisting of glyceryl/PEG100 stearate, sorbitan monostearate, sorbitan palmitate, Steareth-20, Steareth-2, Steareth-21 and Ceteareth-20; a mixture of solvents and/or propenetrating agents selected from the group consisting of propylene glycol, oleyl alcohol, phenoxyethanol and glyceryl triacetate; one or more gelling agents selected from the group consisting of carbomers, cellulose gelling agents, xanthan gums, aluminum magnesium silicates but excluding aluminum magnesium silicate/titanium dioxide/silica, guar gums, polyacrylamides and modified starches; and water.

16. The method of claim 15, wherein the subject has moderate to severe papulopustular rosacea before the treatment.

17. The method of claim 15, wherein the subject has 15 or more of the inflammatory lesions before the treatment.

18. The method of claim 15, wherein the pharmaceutical composition comprises about 1% by weight ivermectin.

19. The method of claim 15, wherein about 27.3% or more reduction in inflammatory lesion counts in the subject is observed by 2 weeks after the initial administration of the pharmaceutical composition.

20. The method of claim 10, wherein the subject has no adverse reaction and the adverse reaction is skin burning sensation or skin irritation.

21. The method of claim 13, wherein the subject has no adverse reaction, wherein the adverse reaction is skin burning sensation or skin irritation.

22. A method of treating inflammatory lesions of rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the inflammatory lesions of rosacea a pharmaceutical composition comprising 1.0% by weight ivermectin and a pharmaceutically acceptable carrier, without co-administration of another active pharmaceutical ingredient, wherein the subject has no adverse reaction and the adverse reaction is skin burning sensation or skin irritation.

23. The method of claim 22, wherein a reduction in inflammatory lesion count in the subject is observed 2 weeks after the initial administration of the pharmaceutical composition.

24. The method of claim 23, wherein the subject has 15 or more inflammatory lesions of the papulopustular rosacea before the treatment.

25. The method of claim 24, wherein the pharmaceutical composition further comprises one or more ingredients selected from the group consisting of: an oily phase comprising dimethicone, cyclomethicone, isopropyl palmitate and/or isopropyl myristate, the oily phase further comprising fatty substances selected from the group consisting of cetyl alcohol, cetostearyl alcohol, stearyl alcohol, palmitostearic acid, stearic acid and self-emulsifiable wax; at least one surfactant-emulsifier selected from the group consisting of glyceryl/PEG100 stearate, sorbitan monostearate, sorbitan palmitate, Steareth-20, Steareth-2, Steareth-21 and Ceteareth-20; a mixture of solvents and/or propenetrating agents selected from the group consisting of propylene glycol, oleyl alcohol, phenoxyethanol and glyceryl triacetate; one or more gelling agents selected from the group consisting of carbomers, cellulose gelling agents, xanthan gums, aluminum magnesium silicates but excluding aluminum magnesium silicate/titanium dioxide/silica, guar gums, polyacrylamides and modified starches; and water.

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