IMVEXXY Drug Patent Profile

Which patents cover Imvexxy, and what generic alternatives are available?

Imvexxy is a drug marketed by Mayne Pharma and is included in one NDA. There are twenty patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-two patent family members in twenty-one countries.

The generic ingredient in IMVEXXY 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 Imvexxy

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

Summary for IMVEXXY

International Patents:	162
US Patents:	20
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	2
Patent Applications:	4,198
Drug Prices:	Drug price information for IMVEXXY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMVEXXY
What excipients (inactive ingredients) are in IMVEXXY?	IMVEXXY excipients list
DailyMed Link:	IMVEXXY at DailyMed

See drug prices for IMVEXXY

Recent Clinical Trials for IMVEXXY

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

Sponsor	Phase
Teva Pharmaceuticals USA	Phase 3
University Hospitals Cleveland Medical Center	Phase 4

See all IMVEXXY clinical trials

Pharmacology for IMVEXXY

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Paragraph IV (Patent) Challenges for IMVEXXY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IMVEXXY	Vaginal Inserts	estradiol	4 mcg and 10 mcg	208564	1	2019-12-30

US Patents and Regulatory Information for IMVEXXY

IMVEXXY is protected by thirty-four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018		RX	Yes	No			Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018		RX	Yes	No			Y

International Patents for IMVEXXY

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

Country	Patent Number	Title	Estimated Expiration
Australia	2012340589	Natural combination hormone replacement formulations and therapies
European Patent Office	3560500	FORMULATIONS DE PROGESTÉRONE (PROGESTERONE FORMULATIONS)
South Korea	20180100567
Australia	2021218231	Vaginal Inserted Estradiol Pharmaceutical Compositions and Methods

Supplementary Protection Certificates for IMVEXXY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
0770388	SPC/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
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

IMVEXXY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for IMVEXXY

Overview of IMVEXXY

IMVEXXY, developed by TherapeuticsMD, Inc., is an estradiol vaginal insert designed to treat moderate to severe dyspareunia (painful sex) due to menopause. It is a key player in the female sexual dysfunction and vaginal atrophy treatment markets.

Market Segment and Positioning

Female Sexual Dysfunction Treatment Market

The global female sexual dysfunction treatment market is projected to grow significantly, driven by the increasing prevalence of sexual dysfunction disorders among menopausal women. IMVEXXY, as a treatment for dyspareunia, benefits from this growing demand. The market is expected to grow from $451.7 million in 2023 to $993.9 million by 2030, at a CAGR of 11.9%[1].

Vaginal Atrophy Treatment Market

In the U.S. vaginal atrophy treatment market, IMVEXXY is part of the dominant drug therapies segment. This segment is driven by the increasing number of drug approvals and launches, as well as investments in R&D by major players. The U.S. vaginal atrophy treatment market was valued at $1.15 billion in 2023 and is projected to reach $1.63 billion by 2032, with a CAGR of 4.1% during the forecast period[3][4].

Financial Performance

Revenue Trends

IMVEXXY's net product revenue has shown mixed trends. In the third quarter of 2022, IMVEXXY's net product revenue was $6.9 million, which decreased by $1.1 million compared to the third quarter of 2021. However, the number of prescriptions dispensed remained relatively stable, with approximately 91,300 prescriptions in the third quarter of 2022[2].

Quarterly and Annual Revenue

For the nine months ended September 30, 2022, IMVEXXY's net product revenue was $20.6 million, down from $24.9 million for the same period in 2021. Despite this decline, the product continues to be adopted by healthcare providers and patients, with over 15,000 healthcare providers prescribing IMVEXXY since its launch[2].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the sales of IMVEXXY, as it did on the broader female sexual dysfunction treatment market. Lockdowns and supply chain disruptions led to a decline in prescriptions and revenue in 2020. However, post-pandemic, there has been a resurgence in demand as patients returned to hospitals and specialty clinics for treatment[1].

Distribution and Accessibility

Distribution Channels

IMVEXXY is available through various distribution channels, including hospital pharmacies, drug stores & retail pharmacies, and online pharmacies. The retail stores & pharmacies segment dominates the market due to the easy accessibility and wide availability of products. This convenience is expected to continue driving the demand for IMVEXXY[3][4].

Competitive Landscape

Key Players

TherapeuticsMD, Inc. competes with other major players in the female sexual dysfunction and vaginal atrophy treatment markets, such as Pfizer Inc. and AbbVie Inc. The competitive landscape is characterized by a focus on R&D, new product launches, and strategic partnerships. For instance, TherapeuticsMD, Inc. has partnered with Mayne Pharma Group Limited to commercialize its products, including IMVEXXY, in the U.S.[4].

Future Outlook

Research and Development

The future growth of IMVEXXY is expected to be driven by ongoing research and development efforts. TherapeuticsMD, Inc. and other market players are emphasizing clinical trials and the development of new pharmacological treatments with limited adverse systemic events. This focus on innovation is anticipated to propel market growth during the forecast period[1].

Market Expansion

The North American market, particularly the U.S., is expected to continue dominating the female sexual dysfunction treatment market. The rising adoption of therapies among women, along with increasing product licensing agreements and approvals for new disease indications, will further boost the market share of IMVEXXY[1].

Key Takeaways

• Growing Market Demand: The global female sexual dysfunction treatment market and the U.S. vaginal atrophy treatment market are expected to grow significantly, driven by increasing prevalence and advancements in treatment options.
• Financial Performance: IMVEXXY's revenue has been impacted by COVID-19 but remains a significant player in the market with stable prescription numbers.
• Distribution Channels: Easy accessibility through retail stores & pharmacies is a key driver for IMVEXXY's demand.
• Competitive Landscape: The market is competitive, with a focus on R&D and strategic partnerships.
• Future Outlook: Ongoing R&D and market expansion in North America are expected to drive future growth.

FAQs

What is IMVEXXY used for?

IMVEXXY is an estradiol vaginal insert used to treat moderate to severe dyspareunia (painful sex) due to menopause.

How has COVID-19 impacted IMVEXXY sales?

COVID-19 led to a decline in prescriptions and revenue in 2020 due to lockdowns and supply chain disruptions. However, post-pandemic demand has resurged as patients returned to healthcare facilities.

Which distribution channels dominate the market for IMVEXXY?

Retail stores & pharmacies dominate the market due to the easy accessibility and wide availability of IMVEXXY.

Who are the key competitors in the market for IMVEXXY?

Key competitors include Pfizer Inc., AbbVie Inc., and other players in the female sexual dysfunction and vaginal atrophy treatment markets.

What drives the future growth of IMVEXXY?

Ongoing research and development, market expansion in North America, and increasing adoption of therapies among women are expected to drive future growth.

Sources

1. Fortune Business Insights: Female Sexual Dysfunction Treatment Market Size, Share [2030][1]
2. TherapeuticsMD: Third Quarter 2022 Financial Results[2]
3. Fortune Business Insights: U.S. Vaginal Atrophy Treatment Market Size, Share [2024-2032][3]
4. Fortune Business Insights: U.S. Vaginal Atrophy Treatment Market Size, Share [2024-2032][4]