Details for Patent: 12,564,565

Which drugs does patent 12,564,565 protect, and when does it expire?

Patent 12,564,565 protects TIROSINT and TIROSINT-SOL and is included in two NDAs.

This patent has three patent family members in three countries.

Summary for Patent: 12,564,565

Title:	Stable pharmaceutical formulations of amino acids, peptides or proteins
Abstract:	The present disclosure relates to pharmaceutical formulations comprising an active ingredient belonging to the amino acid, peptide or protein classes and glycerin as excipient, characterized in that the glycerin has an iron content ≤0.2 ppm and an aldehyde and/or ketone species content ≤5 ppm.
Inventor(s):	Tiziano Fossati, Alessandro Di Maria
Assignee:	IBSA Institut Biochimique SA
Application Number:	US19/209,056
Patent Claim Types: see list of patent claims	Composition; Process; Dosage form;

Drugs Protected by US Patent 12,564,565

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-013	Aug 1, 2007		RX	Yes	No			Y
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-002	Oct 13, 2006		RX	Yes	No			Y
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-014	Jun 22, 2022		RX	Yes	No			Y
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-015	Jun 22, 2022		RX	Yes	No			Y
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-003	Oct 13, 2006		RX	Yes	No			Y
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-016	Jun 22, 2022		RX	Yes	No			Y
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-004	Oct 13, 2006		RX	Yes	No			Y

International Family Members for US Patent 12,564,565

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	121909021
Italy	202300020130
World Intellectual Property Organization (WIPO)	2025068935