Details for Patent: 11,123,331

Which drugs does patent 11,123,331 protect, and when does it expire?

Patent 11,123,331 protects ENVARSUS XR and is included in one NDA.

This patent has thirty patent family members in sixteen countries.

Summary for Patent: 11,123,331

Scope and claims summary:

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, INC. (Cary, NC)
Application Number:	17/085,379
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Drugs Protected by US Patent 11,123,331

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	11,123,331					PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No	11,123,331					PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes	11,123,331					PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

International Family Members for US Patent 11,123,331

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	081520
Canada	2688381
Canada	2729948
Denmark	2167033
Denmark	2575769