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Serving leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
McKinsey
Fuji
Boehringer Ingelheim
Cerilliant
Cipla
Medtronic
US Army
Julphar

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,623,411

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Summary for Patent: 8,623,411
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), Norling; Tomas (Lyngby, DK)
Assignee: Veloxis Pharmaceuticals A/S (Horsholm, DK)
Application Number:13/167,334
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;

Drugs Protected by US Patent 8,623,411

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 ➤ Sign Up ➤ Sign Up PROPHYLAXIS OF ORGAN REJECTION ➤ Sign Up
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ➤ Sign Up ➤ Sign Up PROPHYLAXIS OF ORGAN REJECTION ➤ Sign Up
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up PROPHYLAXIS OF ORGAN REJECTION ➤ 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: 8,623,411

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

Non-Orange Book US Patents Family Members for Patent 8,623,411

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
7,994,214 Solid dispersions comprising tacrolimus ➤ Sign Up
8,591,946 Modified release compositions comprising tacrolimus ➤ Sign Up
9,161,907 Modified release compositions comprising tacrolimus ➤ Sign Up
8,617,599 Modified release compositions comprising tacrolimus ➤ Sign Up
8,889,185 Modified release compositions comprising tacrolimus ➤ Sign Up
9,757,362 Modified release compositions comprising tacrolimus ➤ Sign Up
8,889,186 Modified release compositions comprising tacrolimus ➤ Sign Up
8,623,410 Modified release compositions comprising tacrolimus ➤ Sign Up
8,486,993 Solid dispersions comprising tacrolimus ➤ Sign Up
8,586,084 Modified release compositions comprising tacrolimus ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,623,411

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 473003 ➤ Sign Up
Austria 531368 ➤ Sign Up
Australia 2004267909 ➤ Sign Up
Australia 2004267910 ➤ Sign Up
Brazil PI0413927 ➤ Sign Up
Brazil PI0414000 ➤ Sign Up
Canada 2537041 ➤ Sign Up
Canada 2537044 ➤ Sign Up
China 101869561 ➤ Sign Up
China 1859909 ➤ Sign Up
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Deloitte
Cantor Fitzgerald
Cerilliant
Healthtrust
QuintilesIMS
Medtronic
Argus Health
Fuji

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