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Last Updated: April 19, 2024

Claims for Patent: 9,125,868


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Summary for Patent: 9,125,868
Title:Methods for administering weight loss medications
Abstract: Methods and systems for administration of pharmaceuticals using a unit dosage package that includes a first unit dosage that has a first drug and a second drug, a second unit dosage that has the first drug and the second drug, where the second unit dosage includes a different amount of the second drug than the first unit dosage and a unit dosage package is configured to hold the first unit dosage and the second unit dosage. In preferred embodiments the methods and systems are used for administration of weight loss medications.
Inventor(s): McKinney; Anthony A. (San Diego, CA), Tollefson; Gary (Indianapolis, IN), Weber; Eckard (San Diego, CA), Soltero; Rick (Holly Springs, NC)
Assignee: OREXIGEN THERAPEUTICS, INC. (La Jolla, CA)
Application Number:14/220,349
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,125,868
Patent Claims: 1. A method of administering a pharmaceutical formulation to an individual, comprising: administering a first amount of a pharmaceutical formulation every day for a first week, wherein the first amount of a pharmaceutical formulation comprises about 90 mg of bupropion and an amount of naltrexone selected from the group consisting of about 4 mg and about 8 mg; administering a second amount of a pharmaceutical formulation every day for a second week, wherein the second amount of a pharmaceutical formulation comprises bupropion and naltrexone, and wherein the second amount of a pharmaceutical formulation comprises about twice as much bupropion and about twice as much naltrexone as the first amount of a pharmaceutical formulation; administering a third amount of a pharmaceutical formulation every day for a third week, wherein the third amount of a pharmaceutical formulation comprises bupropion and naltrexone, and wherein the third amount of a pharmaceutical formulation comprises about three times as much bupropion and about three times as much naltrexone as the first amount of a pharmaceutical formulation; and administering a fourth amount of a pharmaceutical formulation every day for a fourth week, wherein the fourth amount of a pharmaceutical formulation comprises bupropion and naltrexone, and wherein the fourth amount of a pharmaceutical formulation comprises about four times as much bupropion and about four times as much naltrexone as the first amount of a pharmaceutical formulation.

2. The method of claim 1, wherein the first amount of a pharmaceutical formulation comprises about 8 mg naltrexone.

3. The method of claim 1, wherein the first amount of a pharmaceutical formulation comprises about 4 mg naltrexone.

4. The method of claim 1, wherein the first amount of a pharmaceutical formulation is in a single oral dosage form.

5. The method of claim 4, wherein the single oral dosage form is selected from the group consisting of a tablet, a pill and a capsule.

6. The method of claim 4, wherein the second amount of a pharmaceutical formulation comprises two of the single oral dosage forms.

7. The method of claim 6, wherein the third amount of a pharmaceutical formulation comprises three of the single oral dosage forms.

8. The method of claim 7, wherein the fourth amount of a pharmaceutical formulation comprises four of the single oral dosage forms.

9. The method of claim 1, wherein the bupropion is in a sustained release formulation and the naltrexone is in a sustained release formulation.

10. The method of claim 9, wherein the first amount of a pharmaceutical formulation is in a single oral dosage form, wherein the second amount of a pharmaceutical formulation comprises two of the single oral dosage forms, wherein the third amount of a pharmaceutical formulation comprises three of the single oral dosage forms, and wherein the fourth amount of a pharmaceutical formulation comprises four of the single oral dosage forms.

11. The method of claim 10, wherein the single oral dosage form is a multilayer tablet comprising a first pharmaceutical layer comprising the sustained release formulation of bupropion and a second pharmaceutical layer comprising the sustained release formulation of naltrexone, and an intermediate layer between the first and the second pharmaceutical layers, wherein the intermediate layer is configured to dissolve rapidly in vivo.

12. The method of claim 9, wherein the first amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion in a first single oral dosage form and the sustained release naltrexone in a second single oral dosage form, wherein the second amount of a pharmaceutical formulation consists of two of the first single oral dosage forms and two of the second single oral dosage forms, wherein the third amount of a pharmaceutical formulation consists of three of the first single oral dosage forms and three of the second single oral dosage forms, and wherein the fourth amount of a pharmaceutical formulation consists of four of the first single oral dosage forms and four of the second single oral dosage forms.

13. The method of claim 9, wherein the first amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion having a first single oral dosage form and the sustained release naltrexone having a second single oral dosage form, wherein the second amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion having a third single oral dosage form, and the sustained release naltrexone having a fourth single oral dosage form, and wherein the third amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion having the first single oral dosage form and the third single oral dosage form, and the sustained release naltrexone having the second single oral dosage form and the fourth single oral dosage form, wherein the fourth amount of a pharmaceutical formulation consists of two of the third single oral dosage forms and two of the fourth single oral dosage forms.

14. The method of claim 1, further comprising identifying said individual as obese, and said administering of said pharmaceutical formulation is for treatment of obesity.

15. The method of claim 10, further comprising identifying said individual as obese, and said administering of said pharmaceutical formulation is for treatment of obesity.

16. The method of claim 11, further comprising identifying said individual as obese, and said administering of said pharmaceutical formulation is for treatment of obesity.

17. A method of administering a pharmaceutical formulation to an obese individual, comprising: identifying an individual as obese; providing to the individual a first amount of a pharmaceutical formulation for daily administration during a first week, wherein the first amount of a pharmaceutical formulation comprises about 90 mg of bupropion and an amount of naltrexone selected from the group consisting of about 4 mg and about 8 mg, wherein the bupropion is in a sustained release formulation and the naltrexone is in a sustained release formulation, and wherein the first amount of a pharmaceutical formulation is in a single oral dosage form; providing to the individual a second amount of a pharmaceutical formulation for daily administration during a second week, and wherein the second amount of a pharmaceutical formulation comprises about twice as much bupropion and about twice as much naltrexone as the first amount of a pharmaceutical formulation; providing to the individual a third amount of a pharmaceutical formulation for daily administration during a third week, wherein the third amount of a pharmaceutical formulation comprises about three times as much bupropion and about three times as much naltrexone as the first amount of a pharmaceutical formulation; and providing to the individual a fourth amount of a pharmaceutical formulation for daily administration during a fourth week, wherein the fourth amount of a pharmaceutical formulation comprises about four times as much bupropion and about four times as much naltrexone as the first amount of a pharmaceutical formulation, and wherein the providing of the first amount of a pharmaceutical formulation, the second amount of a pharmaceutical formulation, the third amount of a pharmaceutical formulation and the fourth amount of a pharmaceutical formulation are for treatment of obesity.

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