Details for Patent: 10,532,049

Which drugs does patent 10,532,049 protect, and when does it expire?

Patent 10,532,049 protects BREKIYA (AUTOINJECTOR) and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,532,049

Title:	Parenteral unit dosage form of dihydroergotamine
Abstract:	A parenteral unit dosage form comprising an aqueous solution of dihydroergotamine or pharmaceutically acceptable salt thereof as a sole active ingredient, one or more pH adjusting agents, and optionally one or more co-solvents, wherein the pH of the aqueous solution is such that it contains substantially lower amount of impurity of Formula I and impurity of Formula II as compared to aqueous solution having a pH of 4.0 or less, when the parenteral unit dosage form is stored at 25° C. and 60% relative humidity for at least three months.
Inventor(s):	Alpesh Goyani, Deepak Singodia, Bhaskar Pallerla, Sudeep Kumar Agrawal, Subhas Balaram Bhowmick, Rajamannar Thennati
Assignee:	PHARMACEUTICAL INDUSTRIES Ltd , Sun Pharmaceutical Industries Ltd
Application Number:	US16/285,495
Patent Claim Types: see list of patent claims	Formulation; Compound; Device; Dosage form;

Drugs Protected by US Patent 10,532,049

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amneal	BREKIYA (AUTOINJECTOR)	dihydroergotamine mesylate	SOLUTION;SUBCUTANEOUS	215400-001	May 14, 2025		RX	Yes	Yes	10,532,049		Y

International Family Members for US Patent 10,532,049

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3826614
World Intellectual Property Organization (WIPO)	2020044367