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Julphar
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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for Patent: 6,884,433

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Summary for Patent: 6,884,433
Title: Sustained release formulation 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 Japanes Pharmacopocia, the 13-th edition, Dissolution Test, No. 2 (Puddles 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 comprises a solid base which is a water-soluble or water-insoluble polymer. The formulation is in the form of a powder, fine powder, granule, tablet or capsule. The formulation is administered to a patient once a day for preventing organ or tissue rejection by transplantation or autoimmune disease. In addition, a solid dispersion composition is provided. The solid dispersion comprises tacrolimus or its hydrate in a mixture containing water-soluble or water-insoluble polymer and an excipient.
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:10/412,281
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;

Drugs Protected by US Patent 6,884,433

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 ➤ Sign Up ➤ Sign Up Y METHOD OF ONCE A DAY ADMINISTRATION ➤ Sign Up
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y METHOD OF ONCE A DAY ADMINISTRATION ➤ Sign Up
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y METHOD OF ONCE A DAY ADMINISTRATION ➤ Sign Up
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: 6,884,433

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 6,884,433

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 ➤ Sign Up
6,440,458 Sustained release preparations ➤ Sign Up
6,576,259 Sustained release formulations containing tacrolimus ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Harvard Business School
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US Department of Justice

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