ephedrine sulfate - Profile

What are the generic drug sources for ephedrine sulfate and what is the scope of patent protection?

Ephedrine sulfate is the generic ingredient in four branded drugs marketed by Exela Pharma, Ph Health, Nexus, Amneal, Caplin, Civica, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Mankind Pharma, Renew Pharms, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in twenty-two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ephedrine sulfate has fourteen patent family members in nine countries.

There is one tentative approval for this compound.

Summary for ephedrine sulfate

International Patents:	14
US Patents:	7
Tradenames:	4
Applicants:	17
NDAs:	22
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ephedrine sulfate

Generic filers with tentative approvals for EPHEDRINE SULFATE

Applicant	Application No.	Strength	Dosage Form
		50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for EPHEDRINE SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPHEDRINE SULFATE	Injection	ephedrine sulfate	25 mg/5 mL and 50 mg/10 mL	213994	1	2023-03-17
EMERPHED	Injection	ephedrine sulfate	50 mg/10 mL	213407	1	2021-10-14

US Patents and Regulatory Information for ephedrine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Exela Pharma	AKOVAZ	ephedrine sulfate	SOLUTION;INTRAVENOUS	208289-002	Aug 2, 2021	AP3	RX	Yes	Yes
Exela Pharma	AKOVAZ	ephedrine sulfate	SOLUTION;INTRAVENOUS	208289-001	Apr 29, 2016	AP	RX	Yes	Yes
Ph Health	CORPHEDRA	ephedrine sulfate	SOLUTION;INTRAVENOUS	208943-001	Jan 27, 2017	AP	RX	No	No
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-002	Feb 28, 2023		RX	Yes	Yes	11,571,398
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-002	Feb 28, 2023		RX	Yes	Yes	11,464,752		Y
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,478,436
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,090,278

International Patents for ephedrine sulfate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021150253
Australia	2020276619
Canada	3140043
China	113825500
European Patent Office	3968975
Israel	288044
Japan	2022532657

Supplementary Protection Certificates for ephedrine sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730