Ephedrine sulfate - Generic Drug Details

What are the generic 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 eighteen 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:	18
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	10,869,845		Y
Endo Operations	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	213994-002	Apr 22, 2022		RX	Yes	Yes	12,029,710
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-002	Feb 28, 2023		RX	Yes	Yes	11,571,398
Hikma	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	214334-001	Dec 15, 2020	AP	RX	No	No
Dr Reddys	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	212649-001	Oct 3, 2020	AP	RX	No	No
Xiromed	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	215825-001	Apr 21, 2022	AP	RX	No	No
Fresenius Kabi Usa	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	209646-001	Aug 4, 2020	AP	RX	No	No

International Patents for ephedrine sulfate

Country	Patent Number	Title	Estimated Expiration
China	113825500	包含麻黄碱或麻黄碱盐的组合物及其制备和使用方法 (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)	2021150253
Israel	288044	תכשירים המכילים אפהרדין או מלח אפהרדין ושיטות להכנתם ולשימוש בהם (Compositions comprising ephedrine or an ephedrine salt and methods of making and using same)
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)
World Intellectual Property Organization (WIPO)	2020232424
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.

Ephedrine sulfate Market Analysis and Financial Projection Experimental

Ephedrine Sulfate Market Dynamics and Financial Trajectory

Market Overview

The global ephedrine sulfate market is poised for significant growth, driven by several key factors. Here is a comprehensive look at the market dynamics and financial trajectory of ephedrine sulfate.

Market Size and Growth

The global ephedrine sulfate market is projected to witness a Compound Annual Growth Rate (CAGR) of 6.1% during the forecast period from 2024 to 2031. The market is expected to grow from USD 122.45 million in 2023 to USD 196.64 million by 2031[1][4].

Drivers of Market Growth

Increasing Prevalence of Spinal Anesthesia-Induced Hypotension

One of the major drivers of the ephedrine sulfate market is the rising incidence of hypotension during spinal anesthesia. A prospective observational study published in 2021 reported that hypotension occurred in 76% of cases where spinal anesthesia was provided during cesarean sections. Ephedrine is the agent of choice for managing and treating this condition, thereby increasing its demand[1][4].

Rising Cases of Bronchial Asthma

The increase in the number of individuals suffering from bronchial asthma is another significant factor. Approximately 7.7% of Americans, or 24.9 million people, had asthma in 2023, with 4.6 million being children and 20.2 million being adults. Ephedrine sulfate is used to relieve acute bronchospasm, making it a crucial component in asthma management[1][4].

Expansion of the Pharmaceutical Sector

The rapid expansion of the pharmaceutical sector globally is also driving the demand for ephedrine sulfate. For instance, the Indian pharmaceutical industry is expected to reach USD 130 billion by 2030, and the UK pharmaceutical industry has a turnover of USD 51.7 billion. This growth in the pharmaceutical sector increases the requirement for ephedrine sulfate due to its various applications[1][4].

Regional Market Analysis

North America

North America holds a significant market share, accounting for 49.1% of global pharmaceutical sales in 2021. The high demand for pharmaceutical products in this region, particularly those requiring ephedrine sulfate with above 99% purity, is a key factor in the market's growth[1].

Asia Pacific

The Asia Pacific region also plays a crucial role, holding around 23% of the global ephedrine market revenue. This region is expected to grow at a CAGR of 7.00% from 2024 to 2031, driven by the increasing demand for pharmaceutical products[3].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global market, with Latin America growing at a CAGR of 4.4% and the Middle East & Africa at a CAGR of 4.7% from 2024 to 2031[3].

Applications and Uses

Ephedrine sulfate is a versatile drug with multiple applications:

Spinal Anesthesia-Induced Hypotension

Ephedrine is used to manage and treat clinically significant hypotension induced by spinal or epidural anesthesia. Its efficacy in preventing hypotension during cesarean sections makes it a critical component in obstetric care[1][4].

Bronchial Asthma

Ephedrine sulfate oral tablets are indicated for providing temporary relief from mild symptoms of intermittent asthma, such as shortness of breath, episodic wheezing, and tightness of the chest[1][4].

Other Medical Conditions

It is also used for treating urinary incontinence, heart failure, rhinitis, depression, and narcolepsy due to its central nervous system stimulatory effects[1][4].

Key Players and Market Leadership

Companies like Avadel Pharmaceuticals play a significant role in the ephedrine sulfate market. Avadel’s product, Akovaz® (ephedrine sulfate), is a market leader in the sterile injectable segment. Despite increased competition, Avadel has maintained market leadership and strong gross margins across its portfolio[2].

Research and Development

The increase in research and development activities to test the efficacy of treatment solutions derived from ephedrine sulfate is expected to further boost market expansion. For example, ongoing studies at institutions like KK Women's and Children's Hospital are exploring new applications and treatment protocols involving ephedrine sulfate[1][4].

Regulatory Environment

The use of ephedrine sulfate is regulated due to its potential for misuse. The Combat Methamphetamine Epidemic Act has implemented strict controls on the sale of products containing ephedrine and pseudoephedrine to prevent diversion for illicit purposes[5].

Financial Trajectory

The financial outlook for the ephedrine sulfate market is positive, with projected revenues increasing significantly over the forecast period. Here are some key financial highlights:

• Market Size: Expected to grow from USD 122.45 million in 2023 to USD 196.64 million by 2031[1][4].
• CAGR: 6.1% from 2024 to 2031[1][4].
• Regional Growth: North America, Asia Pacific, Latin America, and the Middle East & Africa are expected to contribute significantly to the market growth[1][3][4].

Key Takeaways

• The global ephedrine sulfate market is driven by the increasing prevalence of spinal anesthesia-induced hypotension and rising cases of bronchial asthma.
• The rapid expansion of the pharmaceutical sector globally is a significant factor in market growth.
• North America and Asia Pacific are key regions contributing to the market's growth.
• Ephedrine sulfate has multiple medical applications, including managing hypotension and treating asthma.
• Research and development activities are expected to further boost market expansion.
• Regulatory controls are in place to prevent misuse of ephedrine sulfate.

FAQs

What is the projected CAGR of the global ephedrine sulfate market from 2024 to 2031?

The global ephedrine sulfate market is projected to witness a CAGR of 6.1% during the forecast period from 2024 to 2031[1][4].

What are the primary drivers of the ephedrine sulfate market?

The primary drivers include the increasing prevalence of spinal anesthesia-induced hypotension, rising cases of bronchial asthma, and the rapid expansion of the pharmaceutical sector[1][4].

Which regions are expected to contribute significantly to the market growth?

North America, Asia Pacific, Latin America, and the Middle East & Africa are expected to contribute significantly to the market growth[1][3][4].

What are the main applications of ephedrine sulfate?

Ephedrine sulfate is used to manage and treat clinically significant hypotension, relieve acute bronchospasm in asthma, and treat other conditions such as urinary incontinence, heart failure, rhinitis, depression, and narcolepsy[1][4].

Which company is a key player in the ephedrine sulfate market?

Avadel Pharmaceuticals, with its product Akovaz® (ephedrine sulfate), is a key player in the market[2].

What regulatory measures are in place for ephedrine sulfate?

The Combat Methamphetamine Epidemic Act has implemented strict controls on the sale of products containing ephedrine to prevent diversion for illicit purposes[5].

Sources

1. Market Xcel - Markets and Data, "Ephedrine Sulfate Market Assessment, By Purity, By Mode of Administration, By Application, By End-User, and By Region – Global Forecast to 2031" [1].
2. Avadel Pharmaceuticals PLC, "Financial Expectations for the Fiscal Year 2018" [2].
3. Cognitive Market Research, "Global Ephedrine Market Report" [3].
4. Markets and Data, "Global Ephedrine Sulfate Market Assessment, Opportunities and Forecast, 2017-2031F" [4].
5. U.S. Department of Justice, "CMEA General Information - Diversion Control Division" [5].