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Generated: May 26, 2019

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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
Prior Art and Litigation SupportOrder Prior Art and Litigation support for Patent 6,576,259
Patent Claim Types:
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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 Submissiondate
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 Submissiondate

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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

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