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Last Updated: September 29, 2020

DrugPatentWatch Database Preview

Details for Patent: 8,685,998

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Which drugs does patent 8,685,998 protect, and when does it expire?

Patent 8,685,998 protects ENVARSUS XR and is included in one NDA.

This patent has thirty patent family members in sixteen countries.

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 Submissiondate
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y PROPHYLAXIS OF ORGAN REJECTION   Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT   Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS   Start 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

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

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Serving leading biopharmaceutical companies globally:

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