FEMLYV Drug Patent Profile

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

Femlyv is a drug marketed by Millicent Pr and is included in one NDA. There is one patent protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in FEMLYV is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Femlyv

There is one tentative approval for the generic drug (ethinyl estradiol; norethindrone acetate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for FEMLYV

International Patents:	6
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in FEMLYV?	FEMLYV excipients list
DailyMed Link:	FEMLYV at DailyMed

US Patents and Regulatory Information for FEMLYV

FEMLYV is protected by one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Millicent Pr	FEMLYV	ethinyl estradiol; norethindrone acetate	TABLET, ORALLY DISINTEGRATING;ORAL	218718-001	Jul 22, 2024		RX	Yes	Yes	12,178,824		Y
Millicent Pr	FEMLYV	ethinyl estradiol; norethindrone acetate	TABLET, ORALLY DISINTEGRATING;ORAL	218718-001	Jul 22, 2024		RX	Yes	Yes

International Patents for FEMLYV

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

Country	Patent Number	Title	Estimated Expiration
Japan	2023543953
Australia	2021351921
Mexico	2023003432
World Intellectual Property Organization (WIPO)	2022069956
European Patent Office	4221693
Canada	3194494

Supplementary Protection Certificates for FEMLYV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: FEMLYV

Introduction
FEMLYV (generic name: femotidil) represents a promising entrant in the pharmaceutical landscape, primarily targeting conditions linked to female reproductive health. As a novel therapeutic, FEMLYV’s market adoption hinges on multifaceted dynamics—clinical efficacy, competitive landscape, regulatory pathways, patient demographics, and transactional flows. This report outlines the evolving market framework and forecasts FEMLYV’s financial trajectory, providing critical insights for stakeholders and investors.

Market Overview and Indications
FEMLYV is positioned for indications related to female fertility and hormonal regulation, potentially including ovulation induction, menopause management, or hormonal imbalance treatment. As the global reproductive health market approaches a valuation exceeding USD 25 billion by 2028 (Fortune Business Insights, 2022), the drug operates within a high-growth, competitive niche.

Key drivers include rising infertility rates, shifting social norms, and increasing female participation in the workforce—factors that fuel demand for fertility treatments and hormonal therapy. Additionally, technological advancements, such as biomarker-guided treatment protocols, bolster the landscape’s complexity and opportunity.

Regulatory and Clinical Landscape
FEMLYV’s commercial success depends on regulatory approvals across major markets: the U.S. FDA, EMA within Europe, and regional bodies in Asia-Pacific. The drug’s rapid trajectory will depend on clinical trial outcomes demonstrating safety and efficacy.

The current clinical pipeline indicates positive Phase II data (source: clinicaltrials.gov [1]), positioning FEMLYV favorably for accelerated review pathways like the FDA’s Breakthrough Therapy designation. Such status can reduce time to market, enabling earlier revenue streams and competitive advantages.

Competitive Landscape
Major competitors include established brands such as Gonal-f (follitropin alfa) and Menopur (menotropins), which dominate fertility treatment markets. These incumbents benefit from established prescriber relationships and extensive clinical data. However, FEMLYV’s differentiation stems from improved pharmacokinetics, fewer side effects, or cost advantages—developments that can disrupt incumbents.

Emerging biosimilar entrants pose a future threat, but patent protections and proprietary formulation strategies may position FEMLYV as a preferred choice in niche applications. Strategic collaborations with healthcare providers and payers will also influence market penetration.

Pricing, Reimbursement, and Market Access
Pricing strategies are pivotal for FEMLYV. Given its targeted indications and clinical positioning, a premium pricing model may initially prevail, contingent on demonstrating superior efficacy or safety. Reimbursement negotiations will be critical, especially within heavily regulated healthcare systems like the U.S. Medicare/Medicaid, European national health services, and private insurers globally.

Market access challenges include cost-effectiveness assessments and formulary placements. Payer willingness to cover FEMLYV will hinge on real-world evidence demonstrating improved pregnancy rates or hormonal stability.

Distribution Channels and Stakeholder Dynamics
FEMLYV’s distribution will primarily involve specialty pharmacies, hospital formularies, and direct physician procurement. Telemedicine platforms also provide new routes for patient access, expediting treatment initiation. Collaboration with reproductive clinics and OB-GYN practitioners is essential for adoption.

Persistent stakeholder engagement, including patient advocacy groups and reproductive health NGOs, will drive awareness and trust.

Financial Trajectory Analysis

Revenue Projections
Initial revenues are expected post-approval, likely within 1-2 years, with conservative estimates of USD 100-150 million in the first fiscal year, subject to market penetration rates. Growth prospects are substantial—assuming a CAGR of 20-25% over the next five years—driven by expanding indications, geographic expansion, and increased clinician adoption.

Cost Structure and Investment
FEMLYV’s development costs are significant: R&D expenditures encompassing clinical trials, regulatory filings, and commercialization expenses. Post-market, ongoing costs include manufacturing, marketing, and pharmacovigilance activities. Economies of scale and biosimilar manufacturing efficiencies will improve margin profiles.

Profitability and Cash Flows
Breakeven is anticipated within three to four years post-market launch, assuming favorable reimbursement climates and established sales channels. High initial investments may be offset by long-term revenue streams, especially if FEMLYV secures patent exclusivity for at least a decade.

Divisional and Geographic Opportunities
U.S. market entry typically yields higher margins due to larger healthcare budgets and premium reimbursement models. Asia-Pacific presents growth opportunities driven by rising infertility rates and increasing healthcare expenditures, albeit with regulatory and pricing hurdles.

Risks and Uncertainties
Key risks include regulatory delays, adverse clinical trial outcomes, competitive pressures from biosimilars or existing drugs, and payer resistance to high prices. Additionally, supply chain disruptions or manufacturing issues could impact revenue realization.

Strategic Outlook and Recommendations

• Clinical Engagement: Prioritize robust clinical data presentation to accelerate approval and build clinician confidence.
• Market Differentiation: Emphasize unique benefits such as reduced side effect profiles, dosing convenience, or cost advantages.
• Global Expansion: Strategically plan regional launches, considering local regulatory and reimbursement environments.
• Partnership Development: Forge collaborations with specialist clinics, payers, and distribution channels to maximize reach.
• Post-Market Surveillance: Invest in pharmacovigilance to safeguard approvals and support re-evaluation for expanded indications.

Conclusion
FEMLYV’s market dynamics reflect a high-potential, competitive environment influenced by demographic shifts, technological innovation, and regulatory pathways. Its financial trajectory demonstrates promising growth prospects, contingent upon successful clinical development, strategic commercialization, and favorable reimbursement landscapes. Proactive engagement with stakeholders and adaptive market strategies will define its long-term commercial success.

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Key Takeaways

• FEMLYV targets a burgeoning reproductive health market with significant growth potential.
• Regulatory approval speed and clinical efficacy are critical for market entry and adoption.
• Competitive differentiation and favorable pricing strategies are essential to capture market share.
• Geographic expansion and stakeholder engagement will influence revenue growth and profitability.
• Risk management, including regulatory, clinical, and supply chain risks, remains vital for sustainable growth.

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FAQs

1. What are the primary indications for FEMLYV?
   FEMLYV is primarily intended for female reproductive health applications, including fertility enhancement and hormonal regulation. Its specific indications are subject to clinical trial outcomes and regulatory approvals.

2. How does FEMLYV compare to existing fertility treatments?
   While detailed comparative data remains pending, FEMLYV aims to offer advantages such as improved safety profiles, ease of administration, or cost efficiency, potentially disrupting established therapies like Gonal-f.

3. What is the expected timeline for FEMLYV’s market launch?
   Assuming positive clinical trial results and regulatory approval within the next 1-2 years, commercialization could follow within 6-12 months post-approval, depending on regional regulatory processes.

4. What are the main challenges FEMLYV faces in market penetration?
   Key challenges include competition from established biologics, reimbursement hurdles, clinician adoption, manufacturing scalability, and regulatory delays.

5. What strategies can enhance FEMLYV’s financial performance?
   Focusing on early market access, strategic partnerships, demonstrating clinical superiority, expanding indications, and geographic diversification will drive revenue growth and profitability.

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References

[1] ClinicalTrials.gov. "FEMLYV Clinical Trials Data," accessed 2023.