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-nine 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:	109
Clinical Trials:	1
Patent Applications:	4,201
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	6,978,945
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007	6,923,983
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007	6,818,226

International Patents for EVAMIST

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

Country	Patent Number	Title	Estimated Expiration
Germany	69739037
Japan	2007289722	DISPENSING DEVICE
Mexico	PA03004607	DISPOSITIVO DE SUMINISTRO. (DISPENSING DEVICE.)
Australia	1713497
Japan	2004513755

Supplementary Protection Certificates for EVAMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	CA 2012 00011	Denmark
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006

EVAMIST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EVAMIST

Introduction

EVAMIST, a novel estrogen transdermal spray, was developed to treat vasomotor symptoms associated with menopause. This article delves into the market dynamics and financial trajectory of EVAMIST, highlighting its potential, launch, and performance in the pharmaceutical market.

Market Potential and Target Audience

EVAMIST targets the annual $1.3 billion estrogen replacement therapy (ERT) market in the United States. This market is driven by the large number of women entering menopause, with approximately 1.5 million women in the U.S. experiencing menopause each year, and 75% of them reporting symptoms such as hot flashes and night sweats[1].

Acquisition and Licensing

KV Pharmaceutical Company acquired the U.S. marketing rights to EVAMIST from VIVUS, Inc. in 2007. The transaction involved an initial payment of $10 million and an additional payment of approximately $140 million upon FDA approval. There were also milestone payments tied to the product's net sales, with $10 million payable if the product reached $100 million in net sales and up to $20 million if it reached $200 million in net sales[1][3].

FDA Approval and Launch

EVAMIST completed Phase III clinical trials and received FDA approval in July 2007. It was expected to be launched during the second half of KV's fiscal 2008. The product was the first transdermal spray ERT approved for use in the U.S. and was manufactured and supplied by a third party[1][3].

Market Performance

Since its launch, EVAMIST performed exceptionally well. KV Pharmaceutical Company began shipping the product to wholesalers in March 2008, and it quickly gained traction in the market. The company leveraged its existing branded sales force to promote EVAMIST, focusing on OB/GYN and select Primary Care Physicians who prescribe estrogen replacement therapy[1][3].

Financial Projections and Actuals

KV Pharmaceutical estimated EVAMIST's U.S. market potential to be approximately $125 million in peak annual net sales, with gross margins consistent with those of its other branded products. The product was expected to be one of the largest revenue generators for Ther-Rx Corporation, KV's branded subsidiary[1][3].

In fiscal 2008, KV Pharmaceutical reported significant revenue growth, partly due to the introduction of new products like EVAMIST. The company's net revenues increased by 56.1% to $367.9 million, and gross profit totaled $415.3 million, or 69.0% of revenue. Net income for fiscal 2008 was $88.4 million, a 52.1% increase over the previous year[3].

Competitive Landscape

The vasomotor symptoms market, where EVAMIST operates, is expected to grow significantly. By 2024, this market is estimated to be valued at $3.71 billion and is projected to reach $6.40 billion by 2031, growing at a CAGR of 6.8%. Key players in this market include Therapeutics MD, Mithra Pharmaceuticals, KaNDy Pharmaceuticals, and Astellas Pharma, among others[4].

Emerging Markets and Growth Opportunities

Emerging markets, particularly in Asia Pacific, Latin America, Africa, and Eastern Europe, present significant growth opportunities for EVAMIST and similar products. Increased healthcare spending and improving healthcare infrastructure in these regions are expected to boost the demand for advanced therapeutics, including treatments for vasomotor symptoms[4].

Challenges and Future Outlook

Despite the promising market potential, the pharmaceutical industry faces challenges such as regulatory changes, competition from generic and compounded bioidentical hormone therapies, and the need for continuous innovation. For EVAMIST, maintaining market share and compliance with evolving regulatory standards will be crucial for sustained growth[1][5].

Key Takeaways

• Market Potential: EVAMIST targets a $1.3 billion ERT market with estimated peak annual net sales of $125 million.
• Launch and Performance: Launched in 2008, EVAMIST performed well, contributing to KV Pharmaceutical's revenue growth.
• Financial Projections: Expected to be one of Ther-Rx's largest revenue-generating products.
• Competitive Landscape: Part of a growing vasomotor symptoms market with a CAGR of 6.8% from 2024 to 2031.
• Emerging Markets: Significant growth opportunities in emerging markets due to increased healthcare spending.

FAQs

Q: What is EVAMIST used for?

A: EVAMIST is used for the treatment of vasomotor symptoms associated with menopause, such as hot flashes and night sweats.

Q: Who acquired the U.S. marketing rights to EVAMIST?

A: KV Pharmaceutical Company acquired the U.S. marketing rights to EVAMIST from VIVUS, Inc. in 2007.

Q: When was EVAMIST approved by the FDA?

A: EVAMIST received FDA approval in July 2007.

Q: What was the estimated market potential for EVAMIST?

A: The estimated U.S. market potential for EVAMIST was approximately $125 million in peak annual net sales.

Q: How did KV Pharmaceutical promote EVAMIST?

A: KV Pharmaceutical promoted EVAMIST through its existing branded sales force, focusing on OB/GYN and select Primary Care Physicians.

Sources:

1. KV Pharmaceutical Company Acquires U.S. Rights to EvaMist(TM)
   • https://www.biospace.com/kv-pharmaceutical-company-acquires-u-s-rights-to-evamist-tm-a-novel-new-product-for-the-treatment-of-the-symptoms-of-menopause
2. Oregon Drug Use Review / Pharmacy & Therapeutics Committee
   • https://www.orpdl.org/durm/meetings/meetingdocs/2022_06_02/finals/2022_06_02_PnT_Complete.pdf
3. KV Pharmaceutical Annual Report 2008
   • https://www.annualreports.com/HostedData/AnnualReports/PDF/kv-a2008.pdf
4. Vasomotor Symptoms Market Trends, Size, Share & Forecast
   • https://www.coherentmi.com/industry-reports/vasomotor-symptoms-market
5. The Clinical Utility of Compounded Bioidentical Hormone Therapy
   • https://ncpa.org/sites/default/files/2020-07/25791.pdf