IMVEXXY Drug Patent Profile

When do Imvexxy patents expire, 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-eight 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		RX	Yes	No	11,116,717		Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	9,180,091		Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	11,116,717		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	PROGESTERONE FORMULATIONS
Canada	2942568

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

Market Dynamics and Financial Trajectory for IMVEXXY (Ospemifene) in the Global Pharmaceutical Landscape

Last updated: July 27, 2025

---

Introduction

IMVEXXY (ospemifene), developed by TherapeuticsMD, represents a significant entrant in the treatment landscape for moderate-to-severe dyspareunia associated with postmenopausal vulvovaginal atrophy (VVA). As a selective estrogen receptor modulator (SERM), IMVEXXY addresses a niche yet growing market segment driven by demographic shifts and increased awareness. This analysis explores the evolving market environment and forecasts the drug's financial trajectory within the broader pharmaceutical industry.

---

Market Overview and Drivers

The global menopause management market, projected to reach USD 14.2 billion by 2027 with a compound annual growth rate (CAGR) of approximately 6.8%, underpins IMVEXXY’s market potential. The prevalence of menopause-related conditions such as VVA and dyspareunia affects over 50% of postmenopausal women worldwide, translating into a substantial patient population (1).

Key Market Drivers:

• Demographic Shifts: Aging populations, particularly in North America and Europe, increase the postmenopausal cohort requiring symptomatic relief.
• Unmet Medical Needs: Limited non-hormonal treatment options with favorable safety profiles bolster demand for therapies like IMVEXXY.
• Rising Awareness: Education campaigns and physician advocacy improve diagnosis rates, broadening treatment acceptance.
• Regulatory Approvals: FDA approval of IMVEXXY in 2019, with subsequent expansions, align with favorable regulatory pathways for targeted therapies.

---

Competitive Landscape

IMVEXXY operates amidst a competitive environment comprising hormonal therapies, local estrogen treatments, and emerging non-hormonal solutions. Key competitors include:

• Vagifem (estradiol vaginal tablet) and Osphena (ospemifene): Both offer hormonal and non-hormonal options.
• Replens or vaginal moisturizers: OTC products with broader but less targeted efficacy.
• Novel non-hormonal agents: Under development, potentially threatening existing drug share.

IMVEXXY’s differentiator is its safety profile — especially its minimal systemic estrogenic effects, making it suitable for women contraindicated for traditional hormone therapy.

---

Financial Trajectory and Revenue Assumptions

Market Penetration and Adoption

The initial market penetration of IMVEXXY was modest, given the conservative approach to hormone-related therapies and the cautious stance of prescribers. However, recent data suggest growing acceptance, particularly as real-world evidence accumulates indicating favorable safety and efficacy profiles.

Assuming a conservative adoption curve, the following revenue projections are presented:

Year	Estimated Prescriptions	Average Price per Prescription	Revenue (USD millions)
2023	200,000	$350	$70
2024	350,000	$350	$122.5
2025	500,000	$350	$175
2026	750,000	$350	$262.5
2027	1 million	$350	$350

Note: Price per prescription factors in negotiated payer discounts and patient co-pays.

Revenue Drivers:

• Patient Accumulation: Increased diagnosis and prescription rate due to heightened awareness.
• Pricing Strategy: Payer negotiations may pressure gross prices, although premium positioning can sustain higher margins.
• Market Expansion: Approval in additional indications or geographic regions, notably Europe and Asia, could significantly escalate revenues.

---

Regulatory and Marketing Considerations

The success of IMVEXXY hinges on:

• Regulatory Approvals: Expanding indications or gaining approval in Europe (EMA registration) to tap into broader markets.
• Reimbursement Policies: Favorable coverage decisions will accelerate uptake.
• Physician Education: Focused campaigns around safety profile and efficacy will enhance prescriber confidence.
• Post-Marketing Data: Demonstrating long-term safety will be pivotal in maintaining growth momentum.

---

Risks and Challenges

• Market Penetration Risks: Resistance from established hormonal therapies and OTC remedies.
• Pricing Pressures: Payer pushback could compress margins.
• Pipeline Competition: Emergence of non-hormonal therapies, including novel agents under clinical trial, could threaten market share.
• Regulatory Delays: Additional approvals or restrictions could hamper expansion.

---

Strategic Outlook

TherapeuticsMD's continued investment in clinical trials and market education can bolster IMVEXXY's market share. Strategic partnerships with payers and clinicians, coupled with geographic expansion, can accelerate revenue growth. The evolving landscape suggests a potential compound annual growth rate (CAGR) ranging between 10–15% over the next five years, contingent on regulatory and market dynamics.

---

Key Market Opportunities

• Expansion into global markets with burgeoning postmenopausal populations.
• Development of combination therapies integrating IMVEXXY with other modalities.
• Targeted marketing campaigns emphasizing safety advantages over traditional HRT.
• Leveraging digital health tools for patient engagement and adherence.

---

Conclusion

IMVEXXY's market dynamics are characterized by steady growth fueled by demographic trends, unmet needs, and safety advantages. Financially, the drug exhibits promising trajectories aligning with broader industry trends toward personalized, non-hormonal menopause therapies. Strategic positioning, regulatory navigation, and market penetration efforts will be decisive in realizing its full revenue potential.

---

Key Takeaways

• IMVEXXY occupies a niche for postmenopausal women seeking safe, effective treatments for VVA-related dyspareunia.
• Market growth hinges on demographic trends, increased diagnosis, and favorable regulatory pathways.
• Revenue forecasts predict a trajectory of steady growth, with potential acceleration upon geographic expansion and indication approvals.
• Competitive differentiation rests on safety profile, prescriber education, and payer negotiations.
• Navigating risks related to market acceptance and emerging competitors is crucial for maximizing financial outcomes.

---

FAQs

1. What distinguishes IMVEXXY from other treatments for postmenopausal VVA?
IMVEXXY’s selective estrogen receptor modulation offers effective symptomatic relief with a minimal systemic estrogenic effect, reducing risks associated with traditional hormone therapy.

2. How is the global market for menopause-related therapies expected to evolve?
Projected to grow at a CAGR of approximately 6.8%, driven by aging populations and rising awareness, creating expansive opportunities for targeted therapies like IMVEXXY.

3. What challenges does IMVEXXY face in capturing market share?
Established therapies, payer negotiations, regulatory barriers, and competition from emerging non-hormonal agents pose significant hurdles.

4. Are there plans for IMVEXXY’s approval in markets outside the U.S.?
Yes, regulatory submissions in Europe and Asia are underway, which could substantially enhance its global revenue potential.

5. What strategies could accelerate IMVEXXY’s financial growth?
Broadening indications, expanding geographic reach, emphasizing safety benefits, and forming strategic partnerships with payers and healthcare institutions.

---

Sources:
[1] Global Menopause Management Market Report, 2021-2027.
[2] FDA approval archives for IMVEXXY, 2019.
[3] Industry reports on postmenopausal therapy trends.