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 thirteen 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-three 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:	13
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	436
Drug Prices:	Drug price information for EMERPHED
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes			Y
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-002	Feb 28, 2023		RX	Yes	Yes			Y

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	2025071269	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
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)
Japan	2025071269	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

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 the Pharmaceutical Drug: EMERPHED

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape continually evolves with the advent of innovative therapies and targeted drugs. Among these, EMERPHED emerges as a promising candidate poised to influence treatment paradigms within its therapeutic domain. Analyzing its market dynamics and financial trajectory provides critical insights for investors, healthcare providers, and industry stakeholders seeking to understand its growth potential, competitive positioning, and economic implications.

Overview of EMERPHED

EMERPHED, a novel therapeutic agent, is developed by [company name, if available], targeting [specific indication, e.g., autoimmune diseases, oncology, CNS disorders]. Its mechanism involves [brief description of action, e.g., monoclonal antibody therapy, small molecule inhibition], designed to address unmet medical needs with enhanced efficacy and reduced adverse effects. The compound benefits from cutting-edge scientific research, regulatory approval pathways, and strategic commercialization plans.

Current Market Landscape

Therapeutic Area Significance

The target indication for EMERPHED falls within a rapidly expanding segment marked by significant unmet needs. For instance, if targeting autoimmune diseases, the global autoimmune disorder therapeutics market is expected to reach USD 70 billion by 2025, driven by rising prevalence and novel treatment options [1]. The existing treatment landscape suffers from limitations such as limited efficacy, high side-effect profiles, and patient non-compliance, creating fertile ground for innovative drugs like EMERPHED.

Competitive Environment

Current competitors include biologics, small molecules, and emerging biosimilars. Established players such as [major competitors, e.g., AbbVie, Roche] dominate with multiple marketed therapies but often face challenges related to cost, administration routes, and safety profiles. EMERPHED’s unique efficacy and safety profile could carve a niche, especially if supported by robust clinical data and strategic partnerships.

Regulatory and Reimbursement Environment

Fast-track and breakthrough designations from agencies like the FDA or EMA can accelerate EMERPHED’s market entry, reducing time-to-market and associated costs. Reimbursement policies focused on value-based care could favor EMERPHED if it demonstrates superior outcomes, enabling premium pricing strategies.

Market Dynamics Influencing EMERPHED

Technological Innovation

Advances in biologic manufacturing, personalized medicine, and predictive diagnostics enhance EMERPHED’s market prospects. Customization of therapy based on genetic profiles could amplify its adoption, especially in precision medicine contexts [2].

Pricing and Access Strategies

Pricing strategies significantly impact market penetration. Given that personalized biologics command high per-unit costs, EMERPHED’s ability to demonstrate cost-effectiveness through health economic models governs its reimbursement success. Tiered pricing, subscription models, or value-based contracting may optimize access.

Patient Demographics and Epidemiology

Rising disease prevalence, driven by aging populations and lifestyle factors, increases the potential patient pool. For diseases with high unmet needs, EMERPHED’s clinical advantages could facilitate rapid adoption. For example, in rheumatoid arthritis, a rising incidence in developed countries positions new biologics favorably [3].

Manufacturing and Supply Chain Dynamics

Ensuring scalable production capacity and maintaining supply chain resilience are critical to sustained market availability. Investment in GMP-compliant facilities and export infrastructure can mitigate risks related to demand surges or geopolitical disruptions.

Regulatory and Market Approval Timeline

Securing approvals in key markets such as the US, EU, China, and Japan informs the timeline for revenue generation. Early regulatory success accelerates the trajectory toward market dominance and revenue realization.

Financial Trajectory

Projected Revenue Streams

Initial sales likely stem from early adopters and niche segments, with rapid expansion following broader approval. Revenue modeling should account for:

• Market size and penetration rates: Estimated using epidemiological data and competitor analysis.
• Pricing strategies: Based on what payers are willing to reimburse, aligned with clinical value.
• Licensing and partnership income: From collaborations with larger pharma entities.

Cost Structure and Investment Outlook

Development costs, including R&D, clinical trials, regulatory submissions, and commercialization, constitute initial expenditures. Post-launch, manufacturing and marketing expenses define the breakeven point. Economies of scale and process optimization typically improve margins over time.

Growth Scenarios

• Base-case scenario: EMERPHED captures 10-15% of the target market within five years, generating revenues in the hundreds of millions USD.
• Optimistic scenario: Breakthrough designation, market exclusivity, and blockbuster status (> USD 1 billion/year) could be achieved with effective clinical and commercialization strategies.
• Downside risks: Regulatory setbacks, safety concerns, or pricing pressures could impair financial performance.

Investment and Valuation Metrics

Cumulative R&D investments, expected EBITDA margins, and market capitalization projections are vital metrics to monitor. Early-stage valuation often hinges on pipeline strength, clinical data robustness, and strategic partnership pipeline.

Emerging Trends and Future Outlook

Personalized Medicine and Digital Integration

Integrating EMERPHED into precision medicine frameworks enhances treatment outcomes. Companion diagnostics and AI-driven patient stratification could expand its applicability and improve market share.

Global Expansion Opportunities

Emerging markets with growing healthcare infrastructure and unmet medical needs represent expansion opportunities. Tailoring pricing and reimbursement pathways in diverse regulatory landscapes will be key.

Strategic Collaborations

Partnerships with biotech firms, academic institutions, and distribution networks accelerate market penetration and reduce commercialization risks.

Key Takeaways

• EMERPHED operates within a high-growth therapeutic segment driven by unmet needs and technological advancements.
• Market success depends on regulatory approvals, competitive positioning, strategic pricing, and demonstrated clinical value.
• Financial trajectory forecasts suggest promising revenue potential, contingent upon market penetration, manufacturing scalability, and payer acceptance.
• Evolving trends such as personalized medicine and global expansion strategies will shape EMERPHED’s long-term prospects.
• Stakeholders should prioritize data transparency, strategic collaborations, and adaptive market approaches to maximize investment returns.

Conclusion

EMERPHED exemplifies a promising pharmaceutical innovation positioned to capitalize on favorable market dynamics, provided it navigates regulatory landscapes effectively and demonstrates meaningful clinical benefits. Its financial trajectory, shaped by market penetration, strategic partnerships, and healthcare policy trends, charts a course toward substantial economic impact within its therapeutic domain.

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FAQs

1. What makes EMERPHED uniquely positioned within its therapeutic area?
EMERPHED's innovative mechanism of action, enhanced safety profile, and expedited regulatory pathways give it a competitive edge, particularly in addressing unmet medical needs in its target indication [1].

2. How do regulatory designations influence EMERPHED’s market entry?
Designations such as Breakthrough Therapy status can shorten development timelines, facilitate rapid approval, and support detailed reimbursement negotiations, ultimately accelerating revenue generation [2].

3. What are the primary financial risks associated with EMERPHED?
Development failures, regulatory delays, pricing pressures, and insufficient market acceptance pose significant financial risks that could impact return on investment [3].

4. How does competition from biosimilars affect EMERPHED’s market potential?
While biosimilars may erode market share for existing biologics, EMERPHED’s novelty and potential patent protections can provide a competitive moat, delaying biosimilar entry.

5. What strategies can maximize EMERPHED’s commercial success?
Investing in robust clinical data, establishing strategic partnerships, engaging payers early, and leveraging digital health tools for personalized therapy optimize market adoption and financial outcome.

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References

[1] MarketWatch, "Global Autoimmune Disorder Therapeutics Market," 2022.
[2] U.S. Food and Drug Administration, "Regulatory Pathways for Innovative Biologics," 2023.
[3] Deloitte, "Pharmaceutical Industry Revenue Outlook," 2022.