Details for Patent: 12,357,643

Which drugs does patent 12,357,643 protect, and when does it expire?

Patent 12,357,643 protects KYZATREX and is included in one NDA.

This patent has twenty patent family members in eleven countries.

Summary for Patent: 12,357,643

Title:	Emulsion formulations
Abstract:	A SEDDS or SMEDDS or SNEDDS formulation for drug delivery of a lipophilic therapeutic agent, providing enhanced modulation of solubility, stability, absorption, metabolism, and/or pharmacokinetic profile of the therapeutic agent by formulation with a lipophilic surfactant, a hydrophilic surfactant, one or more solubilizers and, optionally, digestible oils, resulting in higher bioavailability of the therapeutic agent administered to a subject in need of such therapeutic agent. Also described are pharmaceutical compositions containing the formulations and methods of making and methods of using the formulations and pharmaceutical compositions. Formulations of the disclosure can be constituted to minimize the synthesis of dihydrotestosterone when the therapeutic agent includes testosterone or testosterone esters.
Inventor(s):	Om Dhingra, James S. Bernstein
Assignee:	Marius Pharmaceuticals LLC
Application Number:	US18/389,167
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Drugs Protected by US Patent 12,357,643

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Marius	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-001	Jul 27, 2022		DISCN	Yes	No	12,357,643		Y			METHOD OF TREATING TESTOSTERONE DEFICIENCY
Marius	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-002	Jul 27, 2022		RX	Yes	No	12,357,643		Y			METHOD OF TREATING TESTOSTERONE DEFICIENCY
Marius	KYZATREX	testosterone undecanoate	CAPSULE;ORAL	213953-003	Jul 27, 2022		RX	Yes	Yes	12,357,643		Y			METHOD OF TREATING TESTOSTERONE DEFICIENCY

International Family Members for US Patent 12,357,643

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2822435
China	105188670
European Patent Office	2519230
European Patent Office	2682111