Last Updated: November 8, 2026

EPHEDRINE SULFATE - Generic Drug Details

Name: EPHEDRINE SULFATE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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, Baxter Hlthcare Corp, 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-three NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for EPHEDRINE SULFATE

International Patents:	14
US Patents:	7
Tradenames:	4
Applicants:	18
NDAs:	23
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	17
Patent Applications:	689
Drug Prices:	Drug price trends for EPHEDRINE SULFATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPHEDRINE SULFATE
What excipients (inactive ingredients) are in EPHEDRINE SULFATE?	EPHEDRINE SULFATE excipients list
DailyMed Link:	EPHEDRINE SULFATE at DailyMed

See drug prices for EPHEDRINE SULFATE

Recent Clinical Trials for EPHEDRINE SULFATE

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

Sponsor	Phase
The Second People's Hospital of Huai'an	PHASE1
Instituto Mexicano del Seguro Social	Phase 4
Medical University of Lodz	NA

See all EPHEDRINE SULFATE clinical trials

Generic filers with tentative approvals for EPHEDRINE SULFATE

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	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

Anatomical Therapeutic Chemical (ATC) Classes for EPHEDRINE SULFATE

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ph Health	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	213994-002	Apr 22, 2022	AP2	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Fresenius Kabi Usa	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	219991-001	Mar 19, 2026	AP2	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for EPHEDRINE SULFATE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021150253		⤷ Start Trial
Australia	2020276619		⤷ Start Trial
Canada	3140043		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EPHEDRINE SULFATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	SPC/GB08/005	United Kingdom	⤷ Start Trial	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	⤷ Start Trial	PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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