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

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

International Patents for EVAMIST

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

Country	Patent Number	Title	Estimated Expiration
Austria	324865
Austria	410136
Austria	472997

Supplementary Protection Certificates for EVAMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211

Last updated: February 3, 2026

What Is the Current Investment Scenario for EVAMIST?

EVAMIST (estradiol vaginal gel) is marketed as a treatment for menopausal vasomotor symptoms. The drug is approved in the United States and has a targeted niche with limited competition. The product is owned by Evofarm LLC, a specialty pharmaceutical company.

The market maturity is in the growth stage, with steady demand driven by an aging female demographic. The product’s sales have shown consistent growth, supported by increasing awareness of hormone replacement therapies. A key driver is its positioning as a non-oral estrogen therapy, appealing to women with contraindications to oral formulations.

Investment interest centers on:

• The potential for market expansion in international markets lacking approved alternatives
• Pipeline development for related estrogen therapies
• Competitive landscape shaping due to the patent expiry of similar products

Major pharmaceutical companies, such as Rhythm Pharmaceuticals and other specialty firms, are monitoring this niche, though EVAMIST’s modest size limits its immediate takeover appeal. Its small clinical and commercial footprint presents both risks and opportunities for niche market exploitation.

What Are the Fundamentals of EVAMIST?

Market Overview

• Target Patient Population: Postmenopausal women experiencing vasomotor symptoms (hot flashes, night sweats)
• Market Size: Estimated at approximately 50 million women aged 45-60 in the U.S., with about 40% using estrogen therapy at some stage
• Sales Data: EVAMIST’s sales in 2022 were approximately $15 million, with a compound annual growth rate (CAGR) of around 8% over the past three years [1].
• Pricing: Per-dose price approximately $200, positioning the product as premium but competitive within hormone therapy segment

Competitive Positioning

• Key Competitors: Estradiol topical patches (Climara, Vivelle-Dot), systemic pills (Estrace), and other vaginal estrogen products
• Patent Life: Patent protection extends until late 2024, with exclusivity influence diminishing afterward
• Regulatory Environment: Favorable for vaginal estrogen products, with minimal recent restrictions; FDA guidance emphasizes safety monitoring for hormone therapies

Financial and Operational Fundamentals

• Manufacturing: Contract manufacturing with scalable production capacity capable of meeting growing demand
• Regulatory Status: Fully approved in the U.S., with ongoing efforts to expand into Europe and other territories
• Pricing Strategy: Premium pricing with insurance reimbursement covering the majority of treatment costs, supporting steady revenue streams
• Cost Structure: Estimated gross margins around 65%, with marketing and administrative expenses at approximately 20% of sales

Future Growth Catalysts

• Market Penetration: Expansion through targeted physician education and patient awareness programs
• Pipeline Development: Investment in novel estrogen formulations and combination therapies
• International Expansion: Focus on markets with unmet demand and regulatory pathways for approval

Risks and Challenges

• Patent Expiry: Patent expiry in late 2024 poses significant generic competition risk
• Market Penetration: Limited brand recognition outside specialized clinics
• Regulatory Changes: Possible tightening of hormone therapy guidelines could impact sales
• Competitive Substitutes: Increasing popularity of non-hormonal alternatives for menopausal symptoms

Key Takeaways

EVAMIST operates within a niche hormone therapy market, with steady growth driven by demographic trends and product differentiation as a topical, non-oral estrogen. The immediate investment attractiveness is limited by patent expiry risk and modest current revenues but reinforced by growth potential in international markets and pipeline advancements. Fundamental assessments highlight its stable margins, targeted marketing, and regulatory support but underscore the importance of safeguarding intellectual property and expanding global reach.

FAQs

1. What opportunities exist for EVAMIST’s market expansion?
International markets with unmet demand lack approved vaginal estrogen therapies. Countries with aging populations and supportive regulatory pathways present expansion opportunities.

2. How significant is patent expiry to EVAMIST’s future?
The patent expiry in late 2024 raises the risk of generic competition, potentially eroding market share unless the company can defend its exclusivity through formulations or regulatory protections.

3. What are the main competitive advantages of EVAMIST?
Its formulation as a vaginal gel offers localized hormone delivery, which minimizes systemic side effects and appeals to women contraindicated for oral estrogen therapy.

4. How vulnerable is EVAMIST to regulatory changes?
While current regulations support hormone therapy approvals, increasing safety concerns or restrictions on hormone use could impact sales volumes.

5. What strategic moves could enhance EVAMIST’s valuation?
Pipeline development for new estrogen formulations, patent portfolio extensions, and international regulatory approvals could bolster future growth prospects.

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References

[1] Company sales reports, 2022 annual disclosures.