EMERPHED Drug Patent Profile

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

Emerphed is a drug marketed by Nexus and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has twelve patent family members in nine countries.

The generic ingredient in EMERPHED 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 Emerphed

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

Summary for EMERPHED

International Patents:	12
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	418
Drug Prices:	Drug price information for EMERPHED
What excipients (inactive ingredients) are in EMERPHED?	EMERPHED excipients list
DailyMed Link:	EMERPHED at DailyMed

See drug prices for EMERPHED

Pharmacology for EMERPHED

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

Paragraph IV (Patent) Challenges for EMERPHED

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMERPHED	Injection	ephedrine sulfate	50 mg/10 mL	213407	1	2021-10-14

US Patents and Regulatory Information for EMERPHED

EMERPHED is protected by five US patents.

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
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,464,752		Y
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,090,278
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-002	Feb 28, 2023		RX	Yes	Yes	11,464,752		Y
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,478,436
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,241,400
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,571,398

International Patents for EMERPHED

See the table below for patents covering EMERPHED around the world.

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)
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
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.)
South Korea	102675027
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 EMERPHED

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

Market Dynamics and Financial Trajectory for EMERPHED (Ephedrine Sulfate Injection)

Introduction to EMERPHED

EMERPHED, developed by Nexus Pharmaceuticals, Inc., is an ephedrine sulfate injection available in pre-filled syringes. This product has garnered significant attention due to its innovative delivery system and the critical role it plays in addressing clinically significant hypotension, particularly in anesthesia settings.

Market Growth Drivers

The market for EMERPHED is driven by several key factors:

Increasing Prevalence of Hypotension and Asthma

The rising cases of spinal anesthesia-induced hypotension and bronchial asthma are significant drivers for the ephedrine sulfate market. As these conditions become more prevalent, the demand for effective treatments like EMERPHED increases[1].

Expansion of the Pharmaceutical Sector

The rapid growth of the pharmaceutical industry globally, especially in regions like North America, Europe, and Asia-Pacific, is bolstering the demand for ephedrine sulfate. The Indian pharmaceutical industry, for example, is expected to reach USD 130 billion by 2030, which will further propel the market[1].

FDA Approvals and Regulatory Support

The approval from the U.S. Food and Drug Administration (FDA) for EMERPHED in pre-filled syringes has been a crucial factor in its market growth. This approval, received in March 2023, highlights the regulatory support for innovative and safe medication delivery systems[3][4].

Financial Trajectory

Current Market Size and Forecast

The global ephedrine sulfate market, which includes products like EMERPHED, is projected to grow from USD 122.45 million in 2023 to USD 196.64 million by 2031, at a Compound Annual Growth Rate (CAGR) of 6.1%[1].

Revenue Contribution

EMERPHED, being a part of this market, contributes significantly to the revenue. The product's availability in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes caters to various clinical needs, enhancing its market share.

Competitive Landscape

The market for pre-filled syringes, which includes EMERPHED, is highly competitive. Key players like Becton, Dickinson and Company, Gerresheimer, and Schott AG are also investing heavily in this segment. However, Nexus Pharmaceuticals' innovative approach and FDA approvals give EMERPHED a competitive edge[4].

Technological and Regulatory Trends

Innovations in Delivery Systems

The introduction of pre-filled syringes like EMERPHED represents a significant innovation in drug delivery. These syringes offer convenience, safety, and precision in dosing, which are critical for healthcare professionals and patients alike[3].

Regulatory Compliance

The FDA's approval process and ongoing regulatory support are essential for the market growth of EMERPHED. Compliance with FDA standards ensures the product's safety and efficacy, further boosting its adoption[3][5].

Geographical Market Dynamics

North America and Europe

These regions are expected to dominate the market for pre-filled syringes, including EMERPHED. The strategic efforts of pharmaceutical companies in these regions, along with significant investments in research and development, drive the market forward[4].

Emerging Markets

Regions like Asia-Pacific are also showing promising growth due to the expanding pharmaceutical sector and increasing healthcare needs. The Indian pharmaceutical industry's projected growth to USD 130 billion by 2030 is a notable example[1].

Challenges and Opportunities

Healthcare Funding and Access

Despite the growth potential, challenges such as inadequate healthcare funding in emerging nations can impact the market. However, the increasing awareness and adoption of pre-filled syringes in these regions present opportunities for expansion[4].

Research and Development

The ongoing research and development activities to test the efficacy of ephedrine sulfate-based treatments will continue to drive the market. Innovations in connected and smart syringes, as well as biodegradable materials, will further enhance the product's appeal[2].

Key Takeaways

• Market Growth: The ephedrine sulfate market, including EMERPHED, is expected to grow at a CAGR of 6.1% from 2024 to 2031.
• Regulatory Support: FDA approvals are crucial for the market growth of EMERPHED.
• Innovative Delivery: Pre-filled syringes like EMERPHED offer significant advantages in terms of safety, convenience, and precision.
• Geographical Dominance: North America and Europe are expected to lead the market, with emerging markets showing promising growth.
• Challenges and Opportunities: While healthcare funding is a challenge, ongoing R&D and increasing adoption present opportunities.

FAQs

1. What is EMERPHED used for? EMERPHED (ephedrine sulfate injection) is used to treat clinically significant hypotension, particularly in anesthesia settings, and for reversible bronchospasm and bronchial asthma[3].

2. What are the available strengths of EMERPHED? EMERPHED is available in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes[3].

3. Who is the manufacturer of EMERPHED? EMERPHED is manufactured by Nexus Pharmaceuticals, Inc.[3].

4. What is the projected market size for the ephedrine sulfate market by 2031? The global ephedrine sulfate market is projected to reach USD 196.64 million by 2031[1].

5. What are the key drivers for the growth of the ephedrine sulfate market? The key drivers include the increasing prevalence of spinal anesthesia-induced hypotension and bronchial asthma, expansion of the pharmaceutical sector, and regulatory approvals[1].

Cited Sources

1. MarketsandData: Ephedrine Sulfate Market Size, Trends And Forecast To 2031
2. The Business Research Company: Global Pre Filled Syringes Market Report 2024
3. BioSpace: Nexus Pharmaceuticals, Inc. Receives FDA Approval for EMERPHED
4. GlobeNewswire: Prefilled Syringes Market Size & Share to Surpass $10.59 Billion by 2030
5. FDA: FY 2020 PDUFA Performance Report

Last updated: 2024-12-16