Claims for Patent: 9,169,212

Summary for Patent: 9,169,212

Title:	Azepane derivatives and methods of treating hepatitis B infections
Abstract:	Provided herein are compounds useful for the treatment of HBV infection in a subject in need thereof, pharmaceutical compositions thereof, and methods of inhibiting, suppressing, or preventing HBV infection in the subject.
Inventor(s):	Hartman; George D. (Lansdale, PA), Kuduk; Scott (Harleysville, PA)
Assignee:	Novira Therapeutics, Inc. (Doylestown, PA)
Application Number:	14/511,964
Patent Claims:	1. A compound, or a pharmaceutically acceptable salt thereof, selected from: ##STR00730## ##STR00731## ##STR00732## ##STR00733## ##STR00734## ##STR00735## ##STR00736## ##STR00737## ##STR00738## ##STR00739## 2. A pharmaceutical composition comprising a compound of claim 1, or a pharmaceutically acceptable salt thereof, together with a pharmaceutically acceptable carrier. 3. A method of treating an HBV infection in an individual in need thereof, comprising administering to the individual a therapeutically effective amount of a compound of claim 1. 4. The method of claim 3, further comprising administering to the individual at least one additional therapeutic agent selected from the group consisting of a HBV polymerase inhibitor, immunomodulatory agents, pegylated interferon, viral entry inhibitor, viral maturation inhibitor, literature-described capsid assembly modulator, reverse transcriptase inhibitor, a cyclophilin/TNF inhibitor, a TLR-agonist, an HBV vaccine, and a combination thereof. 5. The method of claim 4, wherein the therapeutic agent is a reverse transcriptase inhibitor, and is at least one of Zidovudine, Didanosine, Zalcitabine, 2',3'-dideoxyadenosine, Stavudine, Lamivudine, Abacavir, Emtricitabine, Entecavir, Apricitabine, Atevirapine, ribavirin, acyclovir, famciclovir, valacyclovir, ganciclovir, valganciclovir, Tenofovir, Adefovir, cidofovir, Efavirenz, Nevirapine, Delavirdine, and Etravirine. 6. The method of claim 4, wherein the therapeutic agent is a TLR agonist, and wherein the TLR agonist is selected from the group consisting of SM360320 (9-benzyl-8-hydroxy-2-(2-methoxy-ethoxy)adenine) and AZD 8848 (methyl [3-({[3-(6-amino-2-butoxy-8-oxo-7,8-dihydro-9H-purin-9-yl)propyl]- [3-(4-morpholinyl)propyl]amino}methyl)phenyl]acetate). 7. The method of claim 4, wherein the therapeutic agent is an interferon selected from the group consisting of interferon alpha (IFN-.alpha.), interferon beta (IFN-.beta.), interferon lambda (IFN-.lamda.), and interferon gamma (IFN-.gamma.). 8. The method of claim 7, wherein the interferon is interferon-alpha-2a, interferon-alpha-2b, or interferon-alpha-n1. 9. The method of claim 7, wherein the interferon-alpha-2a or interferon-alpha-2b is pegylated. 10. The method of claim 7, wherein the interferon-alpha-2a is pegylated interferon-alpha-2a (PEGASYS). 11. The method of claim 3, further comprising administering to the individual at least one HBV vaccine, a nucleoside HBV inhibitor, an interferon or any combination thereof. 12. The method of claim 11, wherein the HBV vaccine is selected from the group consisting of RECOMBIVAX HB, ENGERIX-B, ELOVAC B, GENEVAC-B, and SHANVAC B. 13. The compound of claim 1 having the following structural formula: ##STR00740## or a pharmaceutically acceptable salt thereof. 14. The compound of claim 1 having the following structural formula: ##STR00741## or a pharmaceutically acceptable salt thereof. 15. The compound of claim 1 having the following structural formula: ##STR00742## or a pharmaceutically acceptable salt thereof. 16. The compound of claim 1 having the following structural formula: ##STR00743## or a pharmaceutically acceptable salt thereof. 17. The compound of claim 1 having the following structural formula: ##STR00744## or a pharmaceutically acceptable salt thereof. 18. The compound of claim 1 having the following structural formula: ##STR00745## or a pharmaceutically acceptable salt thereof. 19. The compound of claim 1 having the following structural formula: ##STR00746## or a pharmaceutically acceptable salt thereof. 20. The compound of claim 1 having the following structural formula: ##STR00747## or a pharmaceutically acceptable salt thereof.

Details for Patent 9,169,212

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Llc	RECOMBIVAX, RECOMBIVAX HB	hepatitis b vaccine (recombinant)	Injection	101066	July 23, 1986	9,169,212	2034-01-16
Glaxosmithkline Biologicals	ENGERIX-B	hepatitis b vaccine (recombinant)	Injection	103239	August 28, 1989	9,169,212	2034-01-16
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	October 16, 2002	9,169,212	2034-01-16
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	January 07, 2004	9,169,212	2034-01-16
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	September 29, 2011	9,169,212	2034-01-16