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Generated: December 15, 2018

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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 Submissiondate
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 PROPHYLAXIS OF ORGAN REJECTION ➤ 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 PROPHYLAXIS OF ORGAN REJECTION ➤ 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 PROPHYLAXIS OF ORGAN REJECTION ➤ 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 Submissiondate

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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

International Family Members for US Patent 8,623,411

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 473003 ➤ Try a Free Trial
Austria 531368 ➤ Try a Free Trial
Australia 2004267909 ➤ Try a Free Trial
Australia 2004267910 ➤ 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:

Johnson and Johnson
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Fuji
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Daiichi Sankyo
Argus Health
Medtronic
McKesson

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