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, Ph Health, Nexus, Amneal, Caplin, 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 NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ephedrine sulfate has fourteen patent family members in nine countries.

There are thirteen drug master file entries for ephedrine sulfate. Twenty-three 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:	16
NDAs:	20
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	17
Patent Applications:	671
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
		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
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-002	Feb 28, 2023		RX	Yes	Yes	11,571,398
Xiromed	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	215825-001	Apr 21, 2022	AP	RX	No	No
Caplin	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	219050-001	Jul 18, 2024	AP	RX	No	No

International Patents for EPHEDRINE SULFATE

Country	Patent Number	Title	Estimated Expiration
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)
China	113825500
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.

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Ephedrine Sulfate

Last updated: July 28, 2025

---

Introduction

Ephedrine sulfate is a sympathomimetic agent primarily used as a bronchodilator and vasopressor in clinical settings. Its historical significance, along with evolving regulatory, competitive, and market factors, shape its current and future financial trajectory. As a key component in anesthesia, emergency medicine, and respiratory care, understanding the market dynamics surrounding ephedrine sulfate is vital for stakeholders aiming to capitalize on or mitigate risks within the pharmaceutical landscape.

---

Market Overview

The global ephedrine sulfate market is characterized by its niche application scope, regulatory oversight, supply chain intricacies, and competitive landscape. Despite being over half a century old, ephedrine sulfate maintains relevance in anesthetic and emergency protocols, especially in regions where alternative agents are limited or more expensive.

In 2022, the global demand for ephedrine sulfate was estimated to be valued at approximately USD 75 million, with an expected compound annual growth rate (CAGR) of around 3-4% over the next five years [1]. The steady demand is driven by its continued use in healthcare settings, particularly in anesthesiology, coupled with its role in pseudoephendrine formulations for nasal decongestion.

---

Driving Factors in Market Dynamics

1. Regulatory Landscape

Regulatory frameworks significantly influence market dynamics, especially concerning production, distribution, and usage. Ephedrine sulfate is classified as a controlled substance in various jurisdictions owing to its potential for misuse in methamphetamine synthesis [2]. The Drug Enforcement Administration (DEA) in the U.S. classifies ephedrine as a List I chemical, imposing stringent record-keeping and handling requirements. Such regulations constrain supply chains and elevate compliance costs, impacting profitability.

Conversely, in regions with more permissive regulations, such as certain Asian markets, production and distribution are comparatively less restrictive, fostering regional market growth.

2. Manufacturing and Supply Chain Factors

Major manufacturers of ephedrine sulfate are primarily in India and China, leveraging cost advantages and established chemical manufacturing expertise. However, dependency on a limited number of producers raises concerns about supply security and price volatility. Additionally, environmental regulations governing chemical manufacturing impact production costs, influencing market pricing.

3. Technological and Formulation Developments

While traditional injectable formulations dominate, advancements in drug delivery systems and alternative agents for vasopressor and bronchodilator therapy restrict demand growth. The emergence of selective adrenergic agonists with improved safety profiles, such as norepinephrine and phenylephrine, marginally encroach on ephedrine sulfate's market segment.

4. Competitive Landscape

The market is concentrated, with a handful of global pharmaceutical companies supplying ephedrine sulfate. Patent expirations for related analogs have reduced R&D barriers for generics, leading to increased availability and competitive pricing. Nonetheless, patent protections for formulations or derivatives remain a potential barrier for certain players.

5. Regional Market Trends

Developed markets, including North America and Western Europe, show stable but mature demand, primarily driven by hospital inventories and regulatory approvals. Emerging markets in Asia-Pacific exhibit higher growth potential driven by expanding healthcare infrastructure and less restrictive regulations.

---

Financial Trajectory Projections

Historical Performance

Historically, the ephedrine sulfate market has experienced modest, steady growth aligned with global pharmaceutical consumption trends. Price fluctuations have been minimal due to its staple status in specific therapeutic areas; however, regulatory constraints and supply chain issues occasionally induce price spikes.

Future Outlook

The projected CAGR of 3-4% reflects a relatively stable market with potential upside from increased production efficiencies and regional market expansion. Nonetheless, factors such as regulatory tightening, the advent of alternative therapies, and potential shifts in clinical guidelines could temper growth.

In particular, increased regulatory scrutiny may restrict supply or hike compliance costs, potentially reducing profitability for producers. Conversely, the re-emergence of ephedrine sulfate in emerging markets or as a fallback in supply shortages could sustain or boost demand.

Pricing Dynamics

Pricing strategies will depend heavily on regulatory compliance and manufacturing costs. In highly regulated markets, prices could stabilize or decline due to competition among generics, whereas supply constraints or increased regulation could push prices upward temporarily.

Market Entrants and Investment

Given its status as a generic, entry barriers are moderate, primarily tied to regulatory approval processes and maintaining supply chain integrity. Investment in manufacturing capacity, especially within emerging markets, presents opportunities for margin gains, provided compliance challenges are effectively managed.

---

Regulatory and Ethical Considerations

Stakeholders must continuously monitor regulatory developments, as tightening controls gradually impact manufacturing licenses and distribution channels. Ethical considerations concerning misuse potential demand strict oversight, which may influence market accessibility and profitability.

---

Emerging Trends and Challenges

• Regulatory Restrictions: Stricter controls could lead to market contraction or production shifts.
• Supply Chain Disruptions: Political, environmental, or economic factors impacting chemical manufacturing countries could threaten supply stability.
• Alternative Agents: Increased use of safer vasopressors may diminish demand.
• Regional Growth Opportunities: Countries with less restrictive regulations could emerge as future growth centers.

---

Conclusion

The financial trajectory of ephedrine sulfate hinges on regulatory policies, regional manufacturing capabilities, competitive pressures, and technological advancements. While projections indicate stable, moderate growth driven by ongoing clinical use and regional demand, factors such as potential regulatory restrictions and technological shifts must be vigilantly monitored.

---

Key Takeaways

• Market Size & Growth: Estimated USD 75 million in 2022 with a CAGR of 3-4%; growth driven by regional demand and healthcare infrastructure development.
• Regulatory Impact: Stringent controls limit supply and increase compliance costs, influencing profitability.
• Supply Chain: Predominantly Asian manufacturing, with vulnerability to geopolitical and environmental factors.
• Competitive Dynamics: Limited players dominate, with increasing generics leading to price competition.
• Future Opportunities: Emerging markets and potential formulation innovations offer growth prospects; however, advancements in alternative therapies pose risks.

---

FAQs

Q1: How do regulatory restrictions influence the global availability of ephedrine sulfate?
Regulatory restrictions, particularly in the U.S. and Europe, impose control measures that limit manufacturing, distribution, and use, leading to supply constraints and higher compliance costs. These measures often restrict non-medical use but can also impact legitimate medical supply chains.

Q2: What role do emerging markets play in the future growth of ephedrine sulfate?
Emerging markets, such as India, China, and Southeast Asian countries, are becoming key growth drivers due to less restrictive regulations, expanding healthcare infrastructure, and lower manufacturing costs, providing opportunities for increased regional supply and consumption.

Q3: Are there technological innovations that could impact ephedrine sulfate’s market?
Yes. Advances in drug delivery systems and the development of newer vasopressor agents with improved safety profiles could reduce reliance on ephedrine sulfate, potentially diminishing its market share over time.

Q4: What environmental or geopolitical factors could threaten supply stability?
Environmental regulations in chemical manufacturing hubs, geopolitical tensions, and export restrictions can disrupt supply chains, leading to shortages and increased prices.

Q5: How do patent laws and intellectual property rights affect ephedrine sulfate formulations?
Since ephedrine sulfate itself is a generic compound, patent protections are primarily on specific formulations or delivery mechanisms. This facilitates market entry for generics, intensifying competition but also shaping innovation opportunities.

---

Sources

[1] MarketWatch, “Ephedrine Sulfate Market Size & Trends,” 2022.
[2] U.S. DEA, “Controlled Substance Act – Regulation of Ephedrine,” 2021.