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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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Queensland Health
Mallinckrodt
Covington
Dow
Fish and Richardson
Harvard Business School
Chinese Patent Office

Generated: May 23, 2018

DrugPatentWatch Database Preview

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 Patent Submitted
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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: 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
PCT Information
PCT FiledAugust 30, 2004PCT Application Number:PCT/DK2004/000573
PCT Publication Date:March 10, 2005PCT Publication Number: WO2005/020993

Non-Orange Book US Patents Family Members for Patent 8,591,946

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
8,889,185 Modified release compositions comprising tacrolimus ➤ Try a Free Trial
8,586,084 Modified release compositions comprising tacrolimus ➤ Try a Free Trial
7,994,214 Solid dispersions comprising tacrolimus ➤ Try a Free Trial
8,623,411 Modified release compositions comprising tacrolimus ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Family Members for US Patent 8,591,946

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Slovenia 1663217 ➤ Try a Free Trial
Slovenia 1663216 ➤ Try a Free Trial
Portugal 1663217 ➤ Try a Free Trial
Portugal 1663216 ➤ 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:

Medtronic
Mallinckrodt
Farmers Insurance
Moodys
Federal Trade Commission
Dow
McKinsey
Chinese Patent Office
US Army

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