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Generated: January 18, 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 ➤ Subscribe ➤ Subscribe Y PROPHYLAXIS OF ORGAN REJECTION ➤ Subscribe
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y PROPHYLAXIS OF ORGAN REJECTION ➤ Subscribe
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y PROPHYLAXIS OF ORGAN REJECTION ➤ Subscribe
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
2,014,038,998 ➤ Subscribe
8,664,239 Tacrolimus for improved treatment of transplant patients ➤ Subscribe
9,549,918 Stabilized tacrolimus composition ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,685,998

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Spain 2634153 ➤ Subscribe
Hungary E028847 ➤ Subscribe
Denmark 2167033 ➤ Subscribe
Denmark 2575769 ➤ Subscribe
Eurasian Patent Organization 201390412 ➤ Subscribe
Eurasian Patent Organization 027869 ➤ Subscribe
European Patent Office 2167033 ➤ Subscribe
European Patent Office 2575769 ➤ Subscribe
Hungary E033011 ➤ Subscribe
South Korea 20110033262 ➤ Subscribe
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving leading biopharmaceutical companies globally:

Julphar
Johnson and Johnson
Boehringer Ingelheim
Harvard Business School
Covington
Cipla
Accenture
Mallinckrodt
Teva

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