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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Express Scripts
Queensland Health
US Department of Justice
Moodys
Cantor Fitzgerald
Citi
Fuji

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,685,998

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Summary for Patent: 8,685,998
Title:Tacrolimus for improved treatment of transplant patients
Abstract: An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.
Inventor(s): Gordon; Robert D. (Sandy Springs, GA), Holm; Per (Vanlose, DK), Lademann; Anne-Marie (Klampenborg, DK), Norling; Tomas (Lyngby, DK)
Assignee: Veloxis Pharmaceuticals A/S (Horsholm, DK)
Application Number:12/499,034
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;

Drugs Protected by US Patent 8,685,998

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 Y 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 Y 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 Y 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: 8,685,998

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark2007 00783May 30, 2007
Denmark2007 01573Nov 7, 2007

Non-Orange Book US Patents Family Members for Patent 8,685,998

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
9,549,918 Stabilized tacrolimus composition ➤ Sign Up
2,014,038,998 ➤ Sign Up
8,664,239 Tacrolimus for improved treatment of transplant patients ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Argus Health
Farmers Insurance
Baxter
Cipla
Cerilliant
Daiichi Sankyo
Express Scripts
QuintilesIMS

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