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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Citi
Dow
Medtronic
Cerilliant
Accenture
Boehringer Ingelheim
Colorcon
Queensland Health

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for Patent: 6,576,259

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Summary for Patent: 6,576,259
Title: Sustained release formulations containing tacrolimus
Abstract:Sustained release formulation containing tacrolimus or its hydrate is provided. The time (T63.2%) required for 63.2% of the maximum amount of tacrolimus or its hydrate to be dissolved is 0.7 to 15 hours. The time is measured in accordance to the Japanese Pharmacopoeia, the 13-th edition, Dissolution Test, No. 2 (Puddle method, 50 rpm) using an aqueous 0.005% hydroxypropyl cellulose solution. This aqueous test solution is adjusted to pH 4.5, accordingly. The formulation further comprise a solid base which is a water-soluble polymer and/or wax. The formulation is in the form of a powder, fine powder, granule, tablet or capsule. Furthermore, the formulation is administered to a patient once a day for preventing organ or tissue rejection by transplantation or autoimmune diseases.
Inventor(s): Yamashita; Kazunari (Kyoto, JP), Hashimoto; Eiji (Wakayama, JP), Nomura; Yukihiro (Osaka, JP), Shimojo; Fumio (Hyogo, JP), Tamura; Shigeki (Osaka, JP), Hirose; Takeo (Kyoto, JP), Ueda; Satoshi (Hyogo, JP), Saitoh; Takashi (Osaka, JP), Ibuki; Rinta (Kyoto, JP), Ideno; Toshio (Osaka, JP)
Assignee: Fujisawa Pharmaceutical Co., Ltd. (Osaka, JP)
Application Number:09/978,025
Patent Claim Types:
see list of patent claims
Formulation; Composition; Dosage form; Use;

Drugs Protected by US Patent 6,576,259

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y METHOD OF ONCE A DAY ADMINISTRATION ➤ Try a Free Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y METHOD OF ONCE A DAY ADMINISTRATION ➤ Try a Free Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y METHOD OF ONCE A DAY ADMINISTRATION ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Foreign Priority and PCT Information for Patent: 6,576,259

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan10-79039Mar 26, 1998
Japan10-182963Jun 29, 1998

Non-Orange Book US Patents Family Members for Patent 6,576,259

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,551,522 Sustained-release formulation ➤ Try a Free Trial
6,440,458 Sustained release preparations ➤ Try a Free Trial
6,884,433 Sustained release formulation containing tacrolimus ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Family Members for US Patent 6,576,259

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Slovakia 286887 ➤ Try a Free Trial
Slovakia 14392000 ➤ Try a Free Trial
Slovenia 1064942 ➤ Try a Free Trial
Russian Federation 2214244 ➤ Try a Free Trial
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Harvard Business School
McKinsey
Colorcon
Cipla
Julphar
Fuji
Moodys
Boehringer Ingelheim

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