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Last Updated: March 29, 2024

Claims for Patent: 10,034,873


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Summary for Patent: 10,034,873
Title:C-met modulator pharmaceutical compositions
Abstract: Pharmaceutical compositions and unit dosage forms comprising Compound I are disclosed. ##STR00001##
Inventor(s): Wilson; Jo Ann (San Francisco, CA), Shah; Khalid (South San Francisco, CA)
Assignee: Exelixis, Inc. (Alameda, CA)
Application Number:15/612,703
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,034,873
Patent Claims: 1. A method of treating liver cancer, comprising administering to a patient in need of such treatment a tablet pharmaceutical composition comprising: 30-32 percent by weight of Compound I, L-malate salt wherein Compound I is: ##STR00005## 38-40 percent by weight of microcrystalline cellulose; 18-22 percent by weight of lactose; 2-4 percent by weight of hydroxypropyl cellulose; 4-8 percent by weight of croscarmellose sodium; 0.2-0.6 percent by weight of colloidal silicon dioxide; and 0.5-1 percent by weight of magnesium stearate; alone or in combination with another therapeutic agent.

2. The method of claim 1, wherein the lactose in the tablet pharmaceutical composition is lactose anhydrous.

3. The method of claim 1, wherein the tablet pharmaceutical composition further comprises a film coating containing hypromellose, titanium dioxide, triacetin, and iron oxide yellow.

4. The method of claim 1, wherein the tablet pharmaceutical composition contains 20 to 100 mg of Compound I.

5. The method of claim 1, wherein the tablet pharmaceutical composition contains 20, 25, 50, 60, 75, 80, or 100 mg of Compound I.

6. The method of claim 1, wherein the liver cancer is hepatocellular carcinoma.

7. A method of treating liver cancer, comprising administering to a patient in need of such treatment a tablet pharmaceutical composition comprising, based on 100 weight/weight percent: 30-32 percent by weight of Compound I, L-malate salt wherein Compound I is: ##STR00006## 38-40 percent by weight of microcrystalline cellulose; 18-22 percent by weight of lactose; 2-4 percent by weight of hydroxypropyl cellulose; 4-8 percent by weight of croscarmellose sodium; 0.2-0.6 percent by weight of colloidal silicon dioxide; and 0.5-1 percent by weight of magnesium stearate; and further comprising a film coating containing hypromellose, titanium dioxide, triacetin, and iron oxide yellow.

8. The method of claim 7, wherein the lactose in the tablet pharmaceutical composition is lactose anhydrous.

9. The method of claim 7, wherein the tablet pharmaceutical composition contains 20 to 100 mg of Compound I.

10. The method of claim 7, wherein the tablet pharmaceutical composition contains 20, 25, 50, 60, 75, 80, or 100 mg of Compound I.

11. The method of claim 7, wherein the liver cancer is hepatocellular carcinoma.

12. A method of treating liver cancer, comprising administering to a patient in need of such treatment a tablet pharmaceutical composition comprising about: TABLE-US-00008 Ingredient (% w/w) Compound I, L-malate salt 31.68 Microcrystalline Cellulose 38.85 Lactose anhydrous 19.42 Hydroxypropyl Cellulose 3.00 Croscarmellose Sodium 6.00 Silicon dioxide, Colloidal 0.30 Magnesium Stearate 0.75 Total 100.00

wherein Compound I is: ##STR00007##

13. The method of claim 12, wherein the tablet pharmaceutical composition contains 20 to 100 mg of Compound I.

14. The method of claim 12, wherein the tablet pharmaceutical composition contains 20, 25, 50, 60, 75, 80, or 100 mg of Compound I.

15. The method of claim 12, wherein the liver cancer is hepatocellular carcinoma.

16. A method of treating liver cancer, comprising administering to a patient in need of such treatment a tablet pharmaceutical composition comprising about: TABLE-US-00009 Ingredient (% w/w) Compound I, L-malate salt 31.68 Microcrystalline Cellulose 38.85 Lactose anhydrous 19.42 Hydroxypropyl Cellulose 3.00 Croscarmellose Sodium 3.00 Total Intra-granular 95.95 Silicon dioxide, Colloidal 0.30 Croscarmellose Sodium 3.00 Magnesium Stearate 0.75 Total 100.00

wherein Compound I is: ##STR00008##

17. The method of claim 16, wherein the tablet pharmaceutical composition contains 20 to 100 mg of Compound I.

18. The method of claim 16, wherein the tablet pharmaceutical composition contains 20, 25, 50, 60, 75, 80,or 100 mg of Compound I.

19. The method of claim 16, wherein the liver cancer is hepatocellular carcinoma.

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