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Last Updated: December 13, 2025

Claims for Patent: 11,571,425

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Summary for Patent: 11,571,425

Title:	Topical formulation for a JAK inhibitor
Abstract:	This invention relates to pharmaceutical formulations for topical skin application comprising (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, or a pharmaceutically acceptable salt thereof, and use in the treatment of skin disorders.
Inventor(s):	Bhavnish Parikh, Bhavesh Shah, Krishnaswamy Yeleswaram
Assignee:	Incyte Corp , Incyte Holdings Corp
Application Number:	US17/704,168
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,571,425
Patent Claims:	1. A pharmaceutical composition, suitable for topical skin application to a human patient with a skin disorder, comprising: (1) a therapeutic agent present in an amount ranging from about 0.5% to about 1.5% by weight of the composition, wherein the therapeutic agent is (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile or a pharmaceutically acceptable salt thereof, and (2) a means for effecting skin permeation of (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile to the patient. 2. The composition according to claim 1, wherein the composition is suitable for application to the patient's skin for up to 84 consecutive days. 3. The composition according to claim 1, wherein the skin disorder is an autoimmune skin disorder. 4. The composition according to claim 1, wherein the skin disorder is associated with JAK1 and/or JAK2. 5. The composition according to claim 1, wherein the skin disorder is chosen from pemphigus vulgaris (PV), bullous pemphigoid (BP), psoriasis, psoriasis vulgaris, atopic dermatitis, and combinations thereof. 6. The composition according to claim 1, wherein the skin disorder is atopic dermatitis. 7. The composition according to claim 1, wherein the therapeutic agent is (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt. 8. A pharmaceutical composition, suitable for topical skin application to a human patient with a skin disorder, comprising: (1) a therapeutic agent present in an amount of about 0.5% by weight of the composition, wherein the therapeutic agent is (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile or a pharmaceutically acceptable salt thereof, and (2) a means for effecting skin permeation of (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile to the patient. 9. The composition according to claim 8, wherein the composition is suitable for application to the patient's skin for up to 84 consecutive days. 10. The composition according to claim 8, wherein the skin disorder is an autoimmune skin disorder. 11. The composition according to claim 8, wherein the skin disorder is associated with JAK1 and/or JAK2. 12. The composition according to claim 8, wherein the skin disorder is chosen from pemphigus vulgaris (PV), bullous pemphigoid (BP), psoriasis, psoriasis vulgaris, atopic dermatitis, and combinations thereof. 13. The composition according to claim 8, wherein the skin disorder is atopic dermatitis. 14. The composition according to claim 8, wherein the therapeutic agent is (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt. 15. A pharmaceutical composition, suitable for topical skin application to a human patient with a skin disorder, comprising: (1) a therapeutic agent present in an amount of about 1.0% by weight of the composition, wherein the therapeutic agent is (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile or a pharmaceutically acceptable salt thereof, and (2) a means for effecting skin permeation of (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile to the patient. 16. The composition according to claim 15, wherein the composition is suitable for application to the patient's skin for up to 84 consecutive days. 17. The composition according to claim 15, wherein the skin disorder is an autoimmune skin disorder. 18. The composition according to claim 15, wherein the skin disorder is associated with JAK1 and/or JAK2. 19. The composition according to claim 15, wherein the skin disorder is chosen from pemphigus vulgaris (PV), bullous pemphigoid (BP), psoriasis, psoriasis vulgaris, atopic dermatitis, and combinations thereof. 20. The composition according to claim 15, wherein the skin disorder is atopic dermatitis. 21. The composition according to claim 15, wherein the therapeutic agent is (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt. 22. A pharmaceutical composition, suitable for topical skin application to a human patient with a skin disorder, comprising: (1) a therapeutic agent present in an amount of about 1.5% by weight of the composition, wherein the therapeutic agent is (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile or a pharmaceutically acceptable salt thereof, and (2) a means for effecting skin permeation of (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile to the patient. 23. The composition according to claim 22, wherein the composition is suitable for application to the patient's skin for up to 84 consecutive days. 24. The composition according to claim 22, wherein the skin disorder is an autoimmune skin disorder. 25. The composition according to claim 22, wherein the skin disorder is associated with JAK1 and/or JAK2. 26. The composition according to claim 22, wherein the skin disorder is chosen from pemphigus vulgaris (PV), bullous pemphigoid (BP), psoriasis, psoriasis vulgaris, atopic dermatitis, and combinations thereof. 27. The composition according to claim 22, wherein the skin disorder is atopic dermatitis. 28. The composition according to claim 22, wherein the therapeutic agent is (R)-3-cyclopentyl-3-[4 (7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid salt.

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