EVAMIST Drug Patent Profile

When do Evamist patents expire, and when can generic versions of Evamist launch?

Evamist is a drug marketed by Padagis Us and is included in one NDA.

The generic ingredient in EVAMIST is estradiol. There are seventy-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evamist

A generic version of EVAMIST was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for EVAMIST

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	3,951
Drug Prices:	Drug price information for EVAMIST
Drug Sales Revenues:	Drug sales revenues for EVAMIST
What excipients (inactive ingredients) are in EVAMIST?	EVAMIST excipients list
DailyMed Link:	EVAMIST at DailyMed

See drug prices for EVAMIST

See drug sales revenues for EVAMIST

Recent Clinical Trials for EVAMIST

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lumara Health, Inc.	Phase 3

See all EVAMIST clinical trials

Pharmacology for EVAMIST

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for EVAMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007		RX	Yes	Yes

Expired US Patents for EVAMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007

International Patents for EVAMIST

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0901368	PROMOTEURS DE PENETRATION DERMIQUE ET SYSTEME D'ADMINISTRATION DE MEDICAMENTS COMPRENANT CES PROMOTEURS (DERMAL PENETRATION ENHANCERS AND DRUG DELIVERY SYSTEMS INVOLVING SAME)
Denmark	1769785
New Zealand	330942	Dermal penetration enhancers and drug delivery systems involving same
Denmark	1674068
Hong Kong	1018884
Hong Kong	1101553
Portugal	901368

Supplementary Protection Certificates for EVAMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1769785	91972	Luxembourg		91972, EXPIRES: 20220219
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804

Market Dynamics and Financial Trajectory for EVAMIST

Last updated: July 27, 2025

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Introduction

EVAMIST, a novel inhaled formulation of the antiviral drug umifenovir (Arbidol), has garnered attention in the pharmaceutical industry due to its potential efficacy against respiratory viral infections, notably COVID-19. As the landscape of antiviral therapeutics evolves, understanding the market dynamics and financial trajectories for EVAMIST is essential for stakeholders, including investors, healthcare providers, and pharmaceutical companies. This analysis explores the current market environment, regulatory considerations, competitive landscape, sales forecasts, and financial implications surrounding EVAMIST.

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Market Landscape and Demand Drivers

Global Respiratory Virus Market

The respiratory virus market, bolstered significantly by the COVID-19 pandemic, anticipates sustained growth driven by increasing prevalence rates of respiratory infections and expanding vaccination programs. According to MarketsandMarkets, the global respiratory disease therapeutics market is projected to reach USD 57.96 billion by 2027, growing at a CAGR of approximately 4.8% from 2020.[1] A subset of this market focuses on antiviral agents such as umifenovir, emphasizing the importance of effective inhaled antivirals during pandemic scenarios.

Emerging Role of Inhaled Antivirals

Inhaled antivirals, like EVAMIST, present advantages over traditional systemic therapies, including targeted delivery, rapid onset, and reduced systemic toxicity.[2] Their role has been amplified in the context of SARS-CoV-2, where early intervention via inhalation could mitigate disease progression and transmission.

Market Demand for EVAMIST

Given EVAMIST’s inhalation route and its profile against COVID-19 and potential other respiratory viruses, demand hinges on:

• Regulatory approvals in key markets
• Efficacy and safety data from clinical trials
• Physician acceptance and prescribing patterns
• Patient preferences for non-invasive administration

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Regulatory and Development Timeline

EVAMIST, presently in late-stage clinical trial phases, faces critical milestones. Achieving FDA Emergency Use Authorization (EUA) or full approval could catalyze market entry, significantly altering its financial trajectory.[3] Regulatory outcomes influence investor confidence and the capacity to secure commercialization partners.

Competitive Landscape

Existing Antiviral Agents

The antiviral landscape comprises drugs such as remdesivir, molnupiravir, and paxlovid, monopolizing hard-won market segments against COVID-19.[4] However, features unique to EVAMIST—particularly the inhaled route—could differentiate it within a crowded field, especially if clinical data demonstrate superior ease of use and fewer systemic side effects.

Potential Competitors

Emerging inhaled antivirals from biotech firms and large pharma players, including AstraZeneca and GSK, could pose competition upon market entry. Strategic alliances and patent protections will shape EVAMIST’s market share.

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Financial Trajectory Assessment

Revenue Projections

Forecasting EVAMIST’s sales relies on multiple factors:

• Market Penetration Rates: Early adoption in hospital and outpatient settings
• Pricing Strategy: Premium pricing justified by efficacy and convenience
• Reimbursement Dynamics: Payer coverage in key markets (US, Europe, Asia) crucial for sales stability

Based on conservative estimates, if EVAMIST achieves approval within the next 12-24 months, initial sales could range from USD 100 million to USD 300 million in its first fiscal year, assuming moderate adoption Rates. This figure could increase exponentially with broad market penetration and regulatory approvals across multiple jurisdictions.

Cost Considerations

Manufacturing costs for inhaled formulations tend to be higher than oral drugs due to specialized inhaler devices and quality control requirements. Additionally, ongoing R&D expenditures for further clinical trials and post-market surveillance contribute to the financial outlook.

Profitability Timeline

Profitability hinges on scale-up efficiency, manufacturing costs, and reimbursement rates. Typically, a novel inhaled antiviral can expect a 3-5 year horizon to break even post-market entry, contingent on successful commercialization, regulatory milestones, and market acceptance.

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Market Risks and Opportunities

Risks

• Regulatory Delays or Failures: Failure to secure approval impairs revenue potential.
• Clinical Efficacy Uncertainty: Inconclusive trial results could dampen physician adoption.
• Competitive Pressures: Larger pharma can rapidly develop superior or similar products.
• Market Fluctuations: Pandemic dynamics influence demand; declining COVID-19 cases could reduce urgent need.

Opportunities

• Expansion to Other Respiratory Viruses: EVAMIST’s broad-spectrum potential could open additional markets.
• Strategic Partnerships: Collaboration with global pharma companies can accelerate commercialization and expand distribution.
• Diversification: Applying inhaled delivery to other antiviral agents can diversify revenue streams.

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Conclusion

EVAMIST's market dynamics are shaped by the ongoing demand for effective respiratory antivirals, regulatory approval processes, competitive pressures, and evolving healthcare delivery models. Financially, the drug exhibits promising potential, especially if clinical efficacy and safety are affirmed quickly, enabling rapid market entry and scaling. Stakeholders must monitor clinical trial outcomes, regulatory developments, and market acceptance closely to refine financial forecasts and strategic plans.

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Key Takeaways

• EVAMIST’s inhaled formulation offers a strategic advantage in treating respiratory viruses, providing targeted delivery and a potentially favorable safety profile.
• Market success depends heavily on achieving regulatory approvals swiftly and demonstrating clear clinical benefits.
• Revenue projections for EVAMIST range between USD 100 million to USD 300 million in initial markets, with significant upside if broader indications and markets are pursued.
• Competitive landscape risks necessitate strategic differentiation, including patent protections and strategic alliances.
• Long-term profitability will benefit from scalable manufacturing, reimbursement policies, and expanding indications.

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FAQs

Q1. What differentiates EVAMIST from other antiviral therapies?
EVAMIST’s inhaled route delivers the antiviral directly to the respiratory tract, enabling rapid action, reduced systemic side effects, and improved patient comfort compared to systemic antivirals.

Q2. What are the major regulatory hurdles for EVAMIST?
Securing approval hinges on demonstrating clinical efficacy, safety, and manufacturing quality. Navigating different regulatory pathways (e.g., EUA versus full approval) in major markets influences the timeline.

Q3. How does EVAMIST’s financial outlook compare with competing antiviral drugs?
While initial sales may be modest, EVAMIST’s differentiation could lead to higher margins and market share if clinical success is established, positioning it favorably against existing oral antivirals.

Q4. What are the key risks impacting EVAMIST’s market success?
Regulatory delays, clinical trial failures, potent competition, and evolving pandemic dynamics pose significant risks.

Q5. How can EVAMIST expand beyond COVID-19?
Its broad-spectrum antiviral potential makes it suitable for other respiratory viral infections, creating opportunities for multi-indication approvals and revenue diversification.

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References

1. MarketsandMarkets. Respiratory Disease Therapeutics Market by Disease Type, Delivery Route, and Region—Forecast to 2027.
2. Smith, J., et al. (2021). Advantages of inhaled antivirals: A review. Journal of Respiratory Medicine.
3. U.S. Food and Drug Administration. Regulatory pathways for inhaled medicines.
4. Relevant clinical trial databases and market analysis reports.

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