EPHEDRINE SULFATE - Generic Drug Details

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, Par Sterile Products, Nexus, Amneal, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Mankind Pharma, Operand Pharms, Renew Pharms, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in sixteen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ephedrine sulfate has eleven patent family members in nine countries.

There are thirteen drug master file entries for ephedrine sulfate. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for EPHEDRINE SULFATE

International Patents:	11
US Patents:	6
Tradenames:	4
Applicants:	16
NDAs:	16
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	14
Patent Applications:	984
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in EPHEDRINE SULFATE?	EPHEDRINE SULFATE excipients list
DailyMed Link:	EPHEDRINE SULFATE at DailyMed

Recent Clinical Trials for EPHEDRINE SULFATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Instituto Mexicano del Seguro Social	Phase 4
Fayoum University	Phase 1
Ain Shams University	N/A

See all EPHEDRINE SULFATE clinical trials

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.

Pharmacology for EPHEDRINE SULFATE

Drug Class	Norepinephrine Releasing Agent alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Increased Norepinephrine Activity

Medical Subject Heading (MeSH) Categories for EPHEDRINE SULFATE

Adrenergic Agents

Central Nervous System Stimulants

Sympathomimetics

Vasoconstrictor Agents

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
Amneal	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	212932-001	Oct 23, 2019	AP	RX	No	No
Xiromed	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	215825-001	Apr 21, 2022	AP	RX	No	No
Sandoz	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	209784-001	Aug 23, 2017	AP	RX	No	No
Zydus Pharms	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	217276-001	May 16, 2023		DISCN	No	No
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-002	Feb 28, 2023		RX	Yes	Yes			Y

International Patents for EPHEDRINE SULFATE

Country	Patent Number	Title	Estimated Expiration
Mexico	2021013888	COMPOSICIONES QUE COMPRENDEN EFEDRINA O UNA SAL DE EFEDRINA Y METODOS DE FABRICACION Y USO DE LAS MISMAS. (COMPOSITIONS COMPRISING EPHEDRINE OR AN EPHEDRINE SALT AND METHODS OF MAKING AND USING SAME.)
European Patent Office	3968975	COMPOSITIONS COMPRENANT DE L'ÉPHÉDRINE OU UN SEL D'ÉPHÉDRINE ET LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (COMPOSITIONS COMPRISING EPHEDRINE OR AN EPHEDRINE SALT AND METHODS OF MAKING AND USING SAME)
World Intellectual Property Organization (WIPO)	2020232424
World Intellectual Property Organization (WIPO)	2021150253
Canada	3140043	COMPOSITIONS COMPRENANT DE L'EPHEDRINE OU UN SEL D'EPHEDRINE ET LEURS PROCEDES DE FABRICATION ET D'UTILISATION (COMPOSITIONS COMPRISING EPHEDRINE OR AN EPHEDRINE SALT AND METHODS OF MAKING AND USING SAME)

Supplementary Protection Certificates for EPHEDRINE SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
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.