Details for Patent: 12,083,103

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Which drugs does patent 12,083,103 protect, and when does it expire?

Patent 12,083,103 protects ENVARSUS XR and is included in one NDA.

This patent has thirty patent family members in sixteen countries.

Summary for Patent: 12,083,103

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):	Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
Assignee:	Veloxis Pharmaceuticals Inc
Application Number:	US17/444,402
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,083,103
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Drugs Protected by US Patent 12,083,103

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						PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No						PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes						PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

International Family Members for US Patent 12,083,103

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	081520
Canada	2688381
Canada	2729948