EPHEDRINE SULFATE Drug Patent Profile

When do Ephedrine Sulfate patents expire, and what generic alternatives are available?

Ephedrine Sulfate is a drug marketed by Amneal, Caplin, Dr Reddys, Endo Operations, 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 fifteen NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in EPHEDRINE SULFATE is ephedrine sulfate. There are sixty-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ephedrine Sulfate

A generic version of EPHEDRINE SULFATE was approved as ephedrine sulfate by SANDOZ on August 23^rd, 2017.

Summary for EPHEDRINE SULFATE

International Patents:	1
US Patents:	2
Applicants:	14
NDAs:	15
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	14
Patent Applications:	551
Drug Prices:	Drug price information 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

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

EPHEDRINE SULFATE is protected by two US patents.

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
Eugia Pharma	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	214579-001	Jun 14, 2021	AP	RX	No	No
Endo Operations	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	213994-002	Apr 22, 2022		RX	Yes	Yes	12,029,710
Mankind Pharma	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	216129-001	Apr 14, 2022	AP	RX	No	No
Fresenius Kabi Usa	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	209646-001	Aug 4, 2020	AP	RX	No	No
Xiromed	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	215825-001	Apr 21, 2022	AP	RX	No	No
Sagent Pharms Inc	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	214528-001	Mar 9, 2023	AP	RX	No	No

International Patents for EPHEDRINE SULFATE

See the table below for patents covering EPHEDRINE SULFATE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021150253

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].