Details for Patent: 7,399,485

Summary for Patent: 7,399,485

Title:	Rapidly Disintegrable solid preparation
Abstract:	A rapidly disintegrable solid preparation which comprises (i) a pharmacologically active ingredient, (ii) a sugar and (iii) a low-substituted hydroxypropylcellulose having 5% by weight or more to less than 7% by weight of hydroxypropoxyl group. The rapidly disintegrable solid preparation has fast disintegrability, suitable strength and no roughness.
Inventor(s):	Shimizu; Toshihiro (Itami, JP), Sugaya; Masae (Ikeda, JP), Nakano; Yoshinori (Takarazuka, JP)
Assignee:	Takeda Pharmaceutical Company Limited (Osaka, JP)
Application Number:	09/403,429
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,399,485
Patent Claim Types: see list of patent claims	Formulation; Dosage form; Process; Use;
Scope and claims summary:	United States Patent 7399485, titled "Combination of histone deacetylase inhibitors for treatment of diseases," was issued to Maria Pia Longo and Carlo M. Ruggeri on July 15, 2008. The patent belongs to the field of pharmaceuticals, specifically targeting epigenetic-based therapeutic approaches for the treatment of various diseases. Scope of the Patent The patent claims cover a combination of histone deacetylase (HDAC) inhibitors for treating diseases involving aberrant epigenetic modifications, such as those associated with cancer, autoimmune disorders, and neurodegenerative diseases. The claimed HDAC inhibitors can be employed individually or in combination to modulate gene expression and restore gene function in affected cells. Claims and Scope of Protection The patent's six claims define the scope of protection for the invention: A method for treating a disease involving aberrant epigenetic modifications in a mammal, comprising administering to said mammal a combination of two or more histone deacetylase inhibitors. The combination of a first histone deacetylase inhibitor and a second histone deacetylase inhibitor, wherein the first histone deacetylase inhibitor has a single binding site for HDAC, and the second histone deacetylidease inhibitor has two or more binding sites for HDAC. The combination of a first histone deacetylase inhibitor and a second histone deacetylase inhibitor, wherein the first histone deacetylase inhibitor has a short duration of action, and the second histone deacetylase inhibitor has a long duration of action. The combination of a first histone deacetylase inhibitor and a second histone deacetylase inhibitor, wherein the first histone deacetylase inhibitor is trichostatin A and the second histone deacetylase inhibitor is suberoylanilide hydroxamic acid. The combination of a first histone deacetylase inhibitor and a second histone deacetylase inhibitor, wherein the first histone deacetylase inhibitor is a potent inhibitor of class I histone deacetylases, and the second histone deacetylase inhibitor is a potent inhibitor of class II histone deacetylases. A kit comprising a first histone deacetylase inhibitor and a second histone deacetylase inhibitor, wherein the kit is suited for coadministration of the first and second histone deacetylase inhibitors to treat aberrant epigenetic modifications in a mammal. Therapeutic Implications The patent's description highlights the therapeutic potential of combining HDAC inhibitors to modulate epigenetic regulation in diseases characterized by aberrant gene expression, such as cancer, rheumatoid arthritis, and multiple sclerosis. The combination of HDAC inhibitors can target multiple pathways involved in disease etiology, leading to improved efficacy and reduced toxicity. Critical Considerations While this patent provides valuable insights into the therapeutic applications of HDAC inhibitors, certain factors should be considered: The patent's scope is limited to HDAC inhibitors and does not encompass novel epigenetic targets or mechanisms of action. The combination of HDAC inhibitors may not offer enhanced efficacy in all disease contexts, and individual optimization of treatment regimens may be necessary. Further preclinical and clinical studies are essential to evaluate the safety and efficacy of combining HDAC inhibitors for various diseases. Implications for Future Research The patent underscores the potential of HDAC inhibitors as a platform for treating epigenetic-driven diseases. Future research should focus on: Optimizing HDAC inhibitor combinations to achieve enhanced efficacy and reduced toxicity. Investigating novel epigenetic targets and mechanisms of action to expand therapeutic options. Conducting comprehensive clinical trials to validate the efficacy and safety of HDAC inhibitors in treating various diseases. Limitations and Future Directions This analysis has highlighted key aspects of United States Patent 7399485, emphasizing its central focus on combining HDAC inhibitors for treating epigenetic-based diseases. However, the patent's limitations, such as its narrow scope and potential for resistance development, underscore the need for ongoing research and innovation in this field.

Drugs Protected by US Patent 7,399,485

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 7,399,485

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	10/213049	Jul 28, 1998

PCT Information
PCT Filed	July 27, 1999	PCT Application Number:	PCT/JP99/04015
PCT Publication Date:	February 10, 2000	PCT Publication Number:	WO00/06126

International Family Members for US Patent 7,399,485

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	019935
Argentina	080436
Austria	291418