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Generated: September 26, 2017

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Title:Compositions comprising nebivolol
Abstract: Nebivolol has been shown to be beneficial in the treatment of cardiovascular diseases such hypertension, congestive heart failure, arterial stiffness and endothelial dysfunction. The present invention features a pharmaceutical composition comprising nebivolol and at least one other active agent, wherein the at least one other active agent is a cardiovascular agent.
Inventor(s): Davis; Eric (Morgantown, WV), O'Donnell; John P. (Morgantown, WV), Bottini; Peter Bruce (Morgantown, WV), Shaw; Andrew (Morgantown, WV), Mason; R. Preston (Manchester, MA)
Assignee: Forest Laboratories Holdings Limited (BM)
Application Number:11/273,992
Patent Claims: 1. A method of treating hypertension comprising administering to a subject in need thereof a composition comprising between about 0.125 mg to about 40 mg nebivolol or a pharmaceutically acceptable salt thereof and between about 1 mg to about 1200 mg of at least one other cardiovascular active agent selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof, wherein the effectiveness of the composition when administered to the subject is greater than treatment with nebivolol or a cardiovascular active agent selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof administered alone.

2. A method of treating a hypertension comprising administering to a subject in need thereof a composition comprising between about 0.125 mg to about 40 mg nebivolol or a pharmaceutically acceptable salt thereof, and between about 1 mg to about 1200 mg of an angiotensin II receptor antagonist (ARB), wherein the ARB is selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof, wherein the treatment is at least 10% more effective than treatment with nebivolol or an ARB selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof administered alone.

3. The method of claim 1 wherein the cardiovascular active agent is olmesartan or a pharmaceutically acceptable salt thereof.

4. The method of claim 1 wherein the cardiovascular active agent is valsartan or a pharmaceutically acceptable salt thereof.

5. The method of claim 1 wherein the cardiovascular active agent is losartan or a pharmaceutically acceptable salt thereof.

6. The method of claim 2 wherein the ARB is olmesartan or a pharmaceutically acceptable salt thereof.

7. The method of claim 2 wherein the ARB is valsartan or a pharmaceutically acceptable salt thereof.

8. The method of claim 2 wherein the ARB is losartan or a pharmaceutically acceptable salt thereof.

9. A method of treating hypertension comprising administering to a subject in need thereof a composition comprising between about 0.125 mg to about 40 mg nebivolol or a pharmaceutically acceptable salt thereof and between about 1 mg to about 1200 mg of a cardiovascular active agent selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof wherein the composition provides a higher therapeutic index than nebivolol or a cardiovascular active agent selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof administered alone.

10. The method of claim 9 wherein the cardiovascular active agent is olmesartan or a pharmaceutically acceptable salt thereof.

11. The method of claim 9 wherein the cardiovascular active agent is valsartan or a pharmaceutically acceptable salt thereof.

12. The method of claim 9 wherein the cardiovascular active agent is losartan or a pharmaceutically acceptable salt thereof.
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Federal Trade Commission
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US Department of Justice
Novartis
Dow
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Boehringer Ingelheim
McKesson
US Army

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