Claims for Patent: 10,548,846
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Summary for Patent: 10,548,846
Title: | Therapeutic compositions for treatment of human immunodeficiency virus |
Abstract: | A solid oral dosage form is provided, comprising a compound of Formula I or a pharmaceutically acceptable salt thereof, tenofovir alafenamide or a pharmaceutically acceptable salt thereof, and emtricitabine or a pharmaceutically acceptable salt thereof. |
Inventor(s): | Collman; Benjamin Micah (Foster City, CA), Hong; Lei (Cupertino, CA), Koziara; Joanna M. (Foster City, CA) |
Assignee: | Gilead Sciences, Inc. (Foster City, CA) |
Application Number: | 15/346,335 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 10,548,846 |
Patent Claims: |
1. A multilayer tablet comprising 50 mg of the compound of Formula I: ##STR00011## or a pharmaceutically acceptable salt thereof, 25 mg tenofovir alafenamide or a
pharmaceutically acceptable salt thereof, and 200 mg emtricitabine or a pharmaceutically acceptable salt thereof wherein the tablet has a total weight of less than about 1000 mg.
2. The tablet of claim 1, wherein the tablet comprises 50 mg of the compound of Formula I as a pharmaceutically acceptable salt thereof, 25 mg tenofovir alafenamide as a pharmaceutically acceptable salt thereof, and 200 mg emtricitabine. 3. The tablet of claim 1 or 2, wherein the tablet comprises 52 mg of the sodium salt of the compound of Formula I and 28 mg tenofovir alafenamide hemifumarate. 4. The tablet of claim 3, wherein the tablet has a total weight of less than about 800 mg. 5. The tablet of claim 3, wherein the tablet has a total weight of less than about 730 mg. 6. The tablet of claim 1 or 2, wherein the tablet contains less than about 15% of the compound of Formula I or a pharmaceutically acceptable salt thereof. 7. The tablet of claim 1 or 2, wherein the tablet contains less than about 11% of the compound of Formula I or a pharmaceutically acceptable salt thereof. 8. The tablet of claim 1 or 2, wherein the tablet is a coated tablet. 9. A tablet, comprising: ##STR00012## (i) a first layer including: 52.5 mg of the compound of Formula II, 246.3 mg microcrystalline cellulose, 19.4 mg croscarmellose sodium, and 4.9 mg magnesium stearate; and (ii) a second layer including: 200 mg emtricitabine, 28 mg tenofovir alafenamine hemifumarate, 113.2 mg microcrystalline cellulose, 30.2 mg croscarmellose sodium, and 5.7 mg magnesium stearate; and (iii) a film coating. 10. The tablet of claim 3, wherein the first layer comprises 52 mg of the compound of Formula II: ##STR00013## and is substantially free of tenofovir alafenamide or a pharmaceutically acceptable salt thereof, and the second layer comprises 28 mg tenofovir alafenamide hemifumarate and 200 mg emtricitabine and is substantially free of the compound of Formula I or a pharmaceutically acceptable salt thereof. |
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