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, Endo Operations, Nexus, Amneal, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Mankind Pharma, Renew Pharms, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in seventeen NDAs. There are seven 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. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for EPHEDRINE SULFATE

International Patents:	11
US Patents:	7
Tradenames:	4
Applicants:	16
NDAs:	17
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	14
Patent Applications:	891
Drug Prices:	Drug price trends 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
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

Anatomical Therapeutic Chemical (ATC) Classes for EPHEDRINE SULFATE

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Endo Operations	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	213994-002	Apr 22, 2022		RX	Yes	Yes
Endo Operations	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	213994-001	Oct 16, 2020		RX	Yes	Yes			Y
Sagent Pharms Inc	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	214528-001	Mar 9, 2023	AP	RX	No	No
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020		RX	Yes	Yes

International Patents for EPHEDRINE SULFATE

Country	Patent Number	Title	Estimated Expiration
Japan	2023091072	エフェドリンまたはエフェドリン塩を含む組成物ならびにその組成物を作製する方法および使用する方法 (COMPOSITIONS COMPRISING EPHEDRINE OR EPHEDRINE SALT AND METHODS OF MAKING AND USING THOSE COMPOSITIONS)
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.)
Japan	2022532657	エフェドリンまたはエフェドリン塩を含む組成物ならびにその組成物を作製する方法および使用する方法
Australia	2020276619	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	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