Claims for Patent: 9,492,423

Summary for Patent: 9,492,423

Title:	Formulations of histone deacetylase inhibitor in combination with bendamustine and uses thereof
Abstract:	Dosing regimens, methods of treatment, controlled release formulations, and combination therapies that include bendamustine, or a pharmaceutically acceptable salt thereof and an HDAC inhibitor, or a pharmaceutically acceptable salt thereof, are described.
Inventor(s):	Loury; David J. (San Jose, CA), Buggy; Joseph J. (Mountain View, CA), Mody; Tarak D. (Sunnyvale, CA), Verner; Erik J. (Belmont, CA), Purro; Norbert (Los Gatos, CA), Balasubramanian; Sriram (San Carlos, CA), Kloos; Ioana (Rueil Malmaison, FR), Depil; Stephane (Issy les Moulineaux, FR)
Assignee:	PHARMACYCLICS LLC (Sunnyvale, CA)
Application Number:	14/344,314
Patent Claims:	1. A pharmaceutical composition, comprising: (a) Compound 1: ##STR00006## or a pharmaceutically acceptable salt thereof; (b) bendamustine or a pharmaceutically acceptable ester, salt or solvate thereof; and (c) at least one pharmaceutically acceptable excipient; wherein (a) and (b) are present in synergistically apoptotic amounts. 2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a solid oral dosage form. 3. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a controlled release pharmaceutical composition. 4. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable salt of Compound 1 is an HCl salt. 5. A method of treating a cancer in an individual in need thereof, comprising administering to the individual (a) bendamustine, or a pharmaceutically acceptable ester, salt or solvate thereof; and (b) Compound 1: ##STR00007## or pharmaceutically acceptable salt thereof, wherein (a) and (b) are present in synergistically apoptotic amounts and the cancer is selected from the group consisting of colon cancer, multiple myeloma, and lymphoma. 6. The method of claim 5, wherein bendamustine and Compound 1, or pharmaceutically acceptable salt of Compound 1, are administered simultaneously. 7. The method of claim 5, wherein bendamustine and Compound 1, or a pharmaceutically acceptable salt of Compound 1, are administered sequentially. 8. The method of claim 5, wherein the pharmaceutically acceptable salt of Compound 1 is an HCl salt. 9. The method of claim 5, further comprising administering to the individual rituximab.

Details for Patent 9,492,423

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2039-02-26
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2039-02-26
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2039-02-26