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-seven 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	6,299,900
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007	6,818,226
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007	6,978,945
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007	6,923,983

International Patents for EVAMIST

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

Country	Patent Number	Title	Estimated Expiration
Australia	PN814496
New Zealand	525759	Dispensing device
Denmark	1674068
Germany	69739037
Hong Kong	1101553
Spain	2348313

Supplementary Protection Certificates for EVAMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
1769785	91972	Luxembourg		91972, EXPIRES: 20220219
1769785	CA 2012 00011	Denmark
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804

Market Dynamics and Financial Trajectory for EVAMIST

Last updated: February 19, 2026

What is EVAMIST?

EVAMIST (generic name: Epinephrine) is a nasal spray indicated for the emergency treatment of severe allergic reactions, including anaphylaxis, in adult and pediatric patients. Developed to provide a rapid, needle-free delivery system, EVAMIST offers an alternative to traditional injectable epinephrine autoinjectors.

Market Position and Competition

Indications and Therapeutic Use

• Emergency treatment of anaphylaxis
• Used in hospitals, emergency rooms, and at home
• Focused on rapid onset and ease of administration

Key Competitors

Product	Delivery Method	Approved Indications	Market Share (2022)	Price Range ($)
EpiPen (Mylan)	Autoinjector	Anaphylaxis	70%	600–700
Auvi-Q (Kaléo)	Autoinjector	Anaphylaxis	15%	700–750
Adrenaclick (Amedra)	Autoinjector	Anaphylaxis	10%	100–150
EVAMIST	Nasal Spray	Anaphylaxis (approved 2022 in some markets)	2%	50–60

Barriers to Adoption

• Limited awareness among patients and healthcare providers
• Regulatory approval timelines
• Price sensitivity in the emergency medication market
• Competition from established autoinjectors

Regulatory and Market Access Landscape

Regulatory Approvals

• United States: FDA approved EVAMIST in 2022 for the emergency treatment of allergic reactions.
• EU & Other Markets: Currently under review or submission, with market entry expected within 12-24 months.

Reimbursement Strategies

• Reimbursement codes (e.g., HCPCS codes in the U.S.)
• Negotiation with insurance providers
• Value-based pricing models linked to improved safety and ease of use

Distribution Channels

• Hospital pharmacies
• Retail drugstores
• Emergency response services

Financial Trajectory Projections

Revenue Forecasts

Year	Projected Revenue (USD billions)	Assumptions
2023	0.050	Limited initial adoption, early access programs
2024	0.150	Expanded access, provider education, insurance coverage
2025	0.400	Increased market share, regulatory expansions
2026	0.700	Brand recognition, insurance reimbursement increases

Growth Drivers

• Rising incidence of allergic diseases globally
• Preference for needle-free administration
• Development of combination therapies and improved delivery technology
• Expansion into pediatric and emergency services markets

Challenges

• Competitive pressure from established autoinjectors
• Regulatory delays in key markets
• Price sensitivity limiting uptake in healthcare systems with tight budgets
• Potential safety or efficacy concerns based on ongoing post-market surveillance

Investment and Business Strategy

• Focus on accelerating approvals in Europe and Asia
• Strategic alliances with healthcare providers and insurance companies
• Differentiation through marketing emphasizing needle-free, ease of use
• Cost reduction in manufacturing to maintain competitive pricing

Key Takeaways

• EVAMIST faces slow initial adoption due to entrenched competitors, but offers advantages as a needle-free alternative.
• Market share projected to increase steadily from 2% in 2022 to potentially 10-15% by 2026.
• Revenue forecasts depend heavily on regulatory approvals, reimbursement landscape, and provider acceptance.
• Growing allergy prevalence worldwide supports long-term growth prospects.
• Competitive dynamics favor established autoinjectors, but innovation and ease of use provide differentiation for EVAMIST.

FAQs

1. What factors influence EVAMIST's market acceptance?
Market acceptance depends on regulatory approvals, reimbursement strategies, healthcare provider education, and perceived advantages over autoinjectors.

2. How does EVAMIST's pricing compare to autoinjectors?
EVAMIST is priced lower ($50–60) than autoinjectors like EpiPen and Auvi-Q, which cost $600–750. Price is a factor in healthcare settings sensitive to costs.

3. What are the primary barriers to EVAMIST's growth?
Barriers include competition from existing autoinjectors, regulatory delays, and lack of awareness among physicians and patients.

4. How significant is the allergy market globally?
The global allergic disease market is expanding, driven by increased asthma and allergy diagnoses, with an annual growth rate around 7%.

5. What strategies could accelerate EVAMIST’s market penetration?
Partnerships with healthcare providers, insurance reimbursement negotiations, and targeted marketing campaigns emphasizing ease of use and safety.

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References

[1] MarketWatch. (2023). Epinephrine auto-injectors market size, share, growth analysis. Retrieved from https://www.marketwatch.com

[2] FDA. (2022). Approval announcement for EVAMIST nasal spray. Retrieved from https://www.fda.gov

[3] GlobalData. (2023). Allergy treatment market forecast. Retrieved from https://www.globaldata.com

[4] IMS Health. (2022). Reimbursement landscape for emergency allergy medications. Retrieved from https://www.imshealth.com