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Last Updated: September 21, 2020

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Details for Patent: 8,591,946

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Summary for Patent: 8,591,946
Title:Modified release compositions comprising tacrolimus
Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s): Holm; Per (Vanlose, DK)
Assignee: Veloxis Pharmaceuticals A/S (Horsholm, DK)
Application Number:10/569,862
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form; Compound;

Drugs Protected by US Patent 8,591,946

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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: 8,591,946

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark2003-01232Aug 29, 2003
Denmark2003-01837Dec 11, 2003
Denmark2004-00079Jan 21, 2004
Denmark2004-00463Mar 23, 2004
Denmark2004-00467Mar 23, 2004
PCT Information
PCT FiledAugust 30, 2004PCT Application Number:PCT/DK2004/000573
PCT Publication Date:March 10, 2005PCT Publication Number: WO2005/020993

International Family Members for US Patent 8,591,946

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 473003   Start Trial
Austria 531368   Start Trial
Australia 2004267909   Start Trial
Australia 2004267910   Start Trial
Brazil PI0413927   Start Trial
Brazil PI0414000   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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