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Serving leading biopharmaceutical companies globally:

UBS
Julphar
Accenture
Dow
US Department of Justice
Fish and Richardson
QuintilesIMS
Cantor Fitzgerald
Express Scripts
Argus Health

Generated: January 18, 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 ➤ Subscribe ➤ Subscribe Y METHOD OF ONCE A DAY ADMINISTRATION ➤ Subscribe
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y METHOD OF ONCE A DAY ADMINISTRATION ➤ Subscribe
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y METHOD OF ONCE A DAY ADMINISTRATION ➤ Subscribe
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
6,440,458 Sustained release preparations ➤ Subscribe
6,884,433 Sustained release formulation containing tacrolimus ➤ Subscribe
8,551,522 Sustained-release formulation ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 6,576,259

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 023299 ➤ Subscribe
Austria 269075 ➤ Subscribe
Austria 464900 ➤ Subscribe
Austria 514419 ➤ Subscribe
Australia 2856399 ➤ Subscribe
Australia 749623 ➤ Subscribe
Brazil 9909201 ➤ Subscribe
Canada 2322516 ➤ Subscribe
China 1229111 ➤ Subscribe
China 1301157 ➤ Subscribe
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving leading biopharmaceutical companies globally:

Chubb
Express Scripts
Cantor Fitzgerald
Accenture
Argus Health
Cipla
Cerilliant
McKinsey
Chinese Patent Office

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