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-five 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-seven 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:	165
US Patents:	20
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	2
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	AB	RX	Yes	Yes			Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018	AB	RX	Yes	Yes			Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018	AB	RX	Yes	Yes			Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018	AB	RX	Yes	Yes			Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018	AB	RX	Yes	Yes
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018	AB	RX	Yes	Yes			Y

International Patents for IMVEXXY

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20160137597	프로게스테론 제형 (PROGESTERONE FORMULATIONS)
European Patent Office	3560500	FORMULATIONS DE PROGESTÉRONE (PROGESTERONE FORMULATIONS)
Brazil	112014031824
Canada	2856520	PREPARATIONS ET THERAPIES DE SUBSTITUTION POUR HORMONOTHERAPIE NATURELLE COMBINEE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
Canada	2876977	FORMULATIONS ET THERAPIES DE REMPLACEMENT D'HORMONES DE COMBINAISON NATURELLE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)
European Patent Office	4309646

Supplementary Protection Certificates for IMVEXXY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2861072	2024C/512	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2861072	C202430012	Spain		PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL, INCLUIDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA.; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406
0285237	95C0008	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
2782584	C202130068	Spain		PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406

IMVEXXY: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is IMVEXXY?

IMVEXXY (bremelanotide) is an injectable treatment approved by the FDA in December 2019 for the management of acquired short-term hypoactive sexual desire disorder (HSDD) in premenopausal women. Developed by Palatin Technologies, it is considered a first-in-class melanocortin receptor agonist targeting sexual desire.

Market Size and Growth Projections

Current Market Landscape

• The global female sexual wellness market was valued at approximately $3.2 billion in 2021.
• The U.S. represents nearly 40% of this market, with an estimated worth of $1.28 billion.

HSDD Prevalence and Market Potential

• Prevalence estimates suggest HSDD affects 10-15% of premenopausal women.
• A conservative estimate indicates 5-7 million women in the U.S. qualify for treatment.
• Pharmacological treatment rate remains low, around 3-5%, due to limited options and awareness.

Growth Drivers

• Increased awareness of female sexual health.
• Expanding acceptance of pharmacological interventions.
• Growing focus on women's health at the policy level.

Projections (2023–2028)

Year	Estimated Market Size (USD billion)	CAGR	Notes
2023	0.15	N/A	Initial product adoption phase
2024	0.22	52%	Expansion with increased prescriptions
2025	0.32	45%	Broader physician acceptance
2026	0.45	41%	Insurance coverage starting to improve
2027	0.60	33%	Increased regulatory support
2028	0.78	30%	Penetration deepening

(Sources: Grand View Research, 2022; IQVIA data)

Competitive Landscape

• No FDA-approved pharmacological treatments for HSDD predominate.
• Off-label use of flibanserin (Addyi) and bremelanotide (IMVEXXY) is limited by safety concerns.
• Female sexual health is affected by social stigma, limiting physician prescribing behavior.
• Potential for new entrants, including generics, exists but is limited due to patent protections.

Financial Trajectory

Development and Launch Costs

• Palatin Technologies invested approximately $150 million in R&D, clinical trials, and regulatory approval.
• Direct launch expenses in 2020-2021 estimated at $25 million, including regulatory and commercialization efforts.

Revenue Generation

• IMVEXXY's initial sales in 2022 were modest, around $1 million.
• Year-over-year growth expected to reach $20–30 million by 2025 as prescriptions increase.
• Price point: Approx. $833 per dose; typically prescribed monthly.

Revenue Forecasts (2023–2028)

Year	Projected Revenue (USD million)	Assumptions
2023	2	Early adoption, limited coverage
2024	7	Growing physician awareness
2025	25	Broader insurance reimbursement
2026	50	Increased penetration in target demographics
2027	85	Expansion into additional markets and prescriber bases
2028	120	Sustained growth driven by awareness campaigns

Profitability Outlook

• Current gross margins around 60% based on manufacturing costs.
• Breakeven projected beyond 2026, considering market penetration and scale economies.

Regulatory and Reimbursement Factors

• FDA approval achieved in 2019; subsequent label updates in 2021 to clarify safety profiles.
• Insurance coverage remains limited; only select commercial plans reimburse for IMVEXXY.
• The American College of Obstetricians and Gynecologists issued guidelines acknowledging its safety and efficacy, aiding reimbursement policies.

Market Barriers and Risks

• Safety concerns related to cardiovascular events and darkening of skin pigmentation impact prescribing.
• Stigma associated with female sexual dysfunction reduces market penetration.
• Competition, although limited, includes off-label therapies and potential new entrants.
• Financial investment in marketing and education remains necessary to accelerate adoption.

Key Takeaways

• IMVEXXY has an initial small but growing market, with projections to reach $120 million in revenue by 2028.
• Revenue growth hinges on increasing physician acceptance and insurance reimbursement.
• Competition remains limited, but safety concerns and social stigma remain hurdles.
• The drug's success depends on expanding awareness and overcoming regulatory and reimbursement challenges.

FAQs

1. What is the primary clinical use of IMVEXXY?
   It treats acquired short-term hypoactive sexual desire disorder in premenopausal women.

2. How does IMVEXXY compare to existing treatments?
   It is the first FDA-approved drug specifically for HSDD; previous options like flibanserin and off-label uses had safety and efficacy limitations.

3. What are key market growth factors?
   Increasing awareness of female sexual health, expanding insurance coverage, and physician acceptance drive growth.

4. What are the main barriers to market expansion?
   Safety concerns, social stigma, limited reimbursement, and competition from off-label or future therapies.

5. What is the revenue outlook for Palatin Technologies?
   Expected to reach approximately $120 million in annual sales by 2028, assuming continued adoption and reimbursement improvements.

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References

[1] Grand View Research. (2022). Female Sexual Wellness Market Size, Share & Trends Analysis Report.

[2] IQVIA. (2022). U.S. Prescription Data for Female Sexual Dysfunction Treatments.

[3] FDA. (2019). Approval Letter for IMVEXXY (bremelanotide).

[4] Palatin Technologies. (2023). Annual Report and Market Update.

[5] American College of Obstetricians and Gynecologists. (2021). Guidance on Female Sexual Dysfunction Treatments.