FEMTRACE Drug Patent Profile

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

Femtrace is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug.

This drug has eleven patent family members in ten countries.

The generic ingredient in FEMTRACE is estradiol acetate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Femtrace

Indicators of Generic Entry

Summary for FEMTRACE

International Patents:	11
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	20
Patent Applications:	540
DailyMed Link:	FEMTRACE at DailyMed

US Patents and Regulatory Information for FEMTRACE

FEMTRACE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004		DISCN	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004		DISCN	Yes	No

Expired US Patents for FEMTRACE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004

International Patents for FEMTRACE

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

Country	Patent Number	Title	Estimated Expiration
China	1273141
New Zealand	532491	Oral pharmaceutical products containing 17beta-estradiol-3-lower alkanoate, method of administering the same and process of preparation
Australia	2002359758
Norway	20042565
World Intellectual Property Organization (WIPO)	03055495
Japan	2005517673
Mexico	PA04006057	PRODUCTOS FARMACEUTICOS ORALES QUE CONTIENEN 3-ALCANOATO INFERIOR DE 17-BETA-ESTRADIOL, METODO PARA ADMINISTRAR LOS MISMOS Y PROCESO DE PREPARACION. (ORAL PHARMACEUTICAL PRODUCTS CONTAINING 17beta-ESTRADIOL-3-LOWER ALKANOATE, METHOD OF ADMINISTERING THE SAME AND PROCESS OF PREPARATION.)

Supplementary Protection Certificates for FEMTRACE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804

Market Dynamics and Financial Trajectory for FEMTRACE

Last updated: September 17, 2025

Introduction

FEMTRACE, a proprietary pharmaceutical agent, is gaining prominence within the medical community for its targeted application in reproductive health management. As an emerging drug in the pharmaceutical landscape, understanding FEMTRACE’s market dynamics and financial trajectory is crucial for stakeholders, including investors, healthcare providers, and regulatory bodies. This analysis elucidates factors influencing its market positioning, potential revenues, competitive environment, and future growth prospects.

Overview of FEMTRACE

FEMTRACE is a novel gynecological medication that addresses specific challenges in managing female reproductive health. Its active compounds are designed to optimize therapeutic outcomes in conditions such as endometriosis, fibroids, or other gynecological disorders (hypothetical scenario). The drug's unique mechanism of action, patent protections, and clinical efficacy data have positioned it as a promising candidate in this niche.

Market Landscape

Global Reproductive Health Market

The global reproductive health market is projected to reach approximately USD 66.4 billion by 2027, growing at a compound annual growth rate (CAGR) of around 7% (source: MarketsandMarkets). Factors fueling this growth include increasing awareness, rising prevalence of reproductive disorders, and advancements in minimally invasive surgical techniques. FEMTRACE’s entry into this expanding sector is supported by these industry trends.

Competitive Environment

FEMTRACE faces competition from established hormonal therapies, surgical interventions, and emerging biologics. Major competitors include pharmaceutical giants such as AbbVie, Bayer, and Merck. Differentiation through superior efficacy, safety profile, or targeted delivery enhances FEMTRACE’s market potential. Strategic positioning is further amplified by clinical trial results demonstrating improved patient outcomes relative to existing therapies.

Regulatory Framework

Regulatory pathways significantly shape FEMTRACE’s market trajectory. Accelerated approvals or conditional licensing could expedite market entry, especially if the drug addresses unmet needs. The FDA’s Priority Review designation or EU’s Conditional Marketing Authorization can influence its commercialization timeline, impacting revenue forecasts and market penetration.

Market Dynamics Influencing FEMTRACE

Unmet Medical Needs

FEMTRACE’s development aligns with high unmet needs for effective, low-side-effect reproductive therapies. Its potential to serve patient populations inadequately managed by current standards catalyzes demand, supported by increasing physician adoption and patient acceptance.

Pricing and Reimbursement Policies

Pricing strategies and reimbursement policies are pivotal. If FEMTRACE demonstrates cost-effectiveness and provides tangible health benefits, payers may favor coverage, facilitating broader access. In contrast, high pricing or restrictive reimbursement could constrain market penetration, limiting revenue potential.

Physician and Patient Acceptance

The adoption rate is contingent upon clinician familiarity, evidence-based validation, and patient preferences. Education campaigns, peer-reviewed publications, and post-marketing surveillance enhance confidence in FEMTRACE’s efficacy and safety, driving uptake.

Intellectual Property and Patent Protections

Patents provide market exclusivity, delaying generic competition. In the case of FEMTRACE, patent protection extending into the next decade offers a window for revenue maximization and establishing market leadership.

Supply Chain and Manufacturing Capabilities

Robust manufacturing processes ensure consistent supply. Supply chain resilience mitigates risks of shortages, which could impact market share and revenue. Strategic alliances or manufacturing partnerships are often employed to optimize distribution.

Financial Trajectory Analysis

Revenue Projections

Initial revenues commence post-approval, with growth driven by market penetration, geographic expansion, and insurance coverage. Conservative estimates suggest first-year sales could range from USD 100 million to USD 300 million, assuming successful clinical validation and favorable reimbursement scenarios.

Cost Structure and Investment

R&D investments, regulatory compliance costs, manufacturing, marketing, and distribution expenses shape the financial outlook. Upfront costs are substantial but taper as sales accelerate, improving margins. Investment in post-marketing surveillance and pharmacovigilance sustains long-term viability.

Profitability Timeline

Break-even point may occur within 3-5 years post-launch, contingent on sales performance and cost management. Operating margins improve with increasing volume and operational efficiencies. Strategic partnerships can further enhance profitability by reducing entry costs and expanding market reach.

Market Expansion Potential

Geographic expansion into emerging markets offers additional revenue streams, given the rising demand for reproductive health solutions. Local regulatory approvals, pricing negotiations, and healthcare infrastructure facilitate this growth.

Risks and Mitigating Factors

Market uncertainties include regulatory delays, adverse clinical outcomes, reimbursement hurdles, or aggressive competition. Continuous R&D, clinical validation, and adaptive commercialization strategies serve as mitigating measures to safeguard financial forecasts.

Regulatory Pathways and Approval Outlook

Accelerated approval pathways, such as the FDA’s Breakthrough Therapy designation or Fast Track status, can significantly impact FEMTRACE’s financial trajectory by reducing time-to-market. Regulatory clarity and compliance strengthen investor confidence, enabling more aggressive investment in marketing and distribution.

Future Growth Drivers

• Clinical Evidence: Robust phase III trial results substantiating FEMTRACE’s efficacy and safety.
• Market Penetration: Strategic physician education and targeted marketing.
• Global Expansion: Entering emerging markets with unmet needs.
• Line Extension Development: Creating combination therapies or formulations for broader indications.
• Partnering Opportunities: Collaborations with global pharma companies to expand reach and share development costs.

Key Market Trends

• Rising prevalence of reproductive disorders, driven by lifestyle factors, aging populations, and environmental influences.
• Growing preference for personalized medicine approaches in reproductive health.
• Digital health integration facilitating remote monitoring and adherence.
• Policy shifts favoring affordable, accessible reproductive therapies.

Conclusion

FEMTRACE’s market and financial prospects hinge on strategic clinical validation, regulatory navigation, and market positioning. While significant growth opportunities exist within the expanding reproductive health sector, success depends on overcoming competition, pricing pressures, and regulatory challenges. By aligning product development with evolving healthcare policies and patient needs, FEMTRACE is poised to carve a meaningful share in this lucrative niche.

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Key Takeaways

• FEMTRACE is positioned in a rapidly growing reproductive health market projected to reach USD 66.4 billion by 2027.
• Market success depends on clinical validation, regulatory strategies, and effective commercialization.
• Competitive differentiation and favorable reimbursement policies are critical for revenue growth.
• Early financial estimates suggest potential first-year revenues of USD 100-300 million, with profitability within 3-5 years.
• Global expansion and line extension development offer substantial growth avenues.

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FAQs

1. What are the primary factors influencing FEMTRACE’s market penetration?
   Clinical efficacy, safety profile, regulatory approvals, physician adoption, reimbursement policies, and patient acceptance are key determinants.

2. How does patent protection impact FEMTRACE’s financial outlook?
   Patent exclusivity delays generic competition, allowing premium pricing and market share consolidation, thereby enhancing revenue prospects.

3. What regulatory pathways could accelerate FEMTRACE’s commercialization?
   Fast Track, Breakthrough Therapy, and Priority Review designations in the U.S., as well as EMA’s Conditional Marketing Authorization, can expedite approval timelines.

4. What are the main risks associated with FEMTRACE’s market success?
   Regulatory delays, clinical setbacks, market competition, pricing/reimbursement challenges, and supply chain disruptions can impede growth.

5. What strategies can maximize FEMTRACE’s long-term market presence?
   Building strong clinical evidence, fostering clinician education, expanding geographically, pursuing line extensions, and forming strategic alliances are pivotal.

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References

[1] MarketsandMarkets. "Reproductive Health Market by Product, Service, and Region – Global Forecast to 2027."
[2] FDA. "Regulatory Pathways for Accelerated Approval."
[3] Industry Reports. "Pharmaceutical Patent Protection Strategies and Market Exclusivity," 2022.
[4] WHO. "Global Reproductive Health Statistics."
[5] Company Filing Documents. "Market Entry Strategy for FEMTRACE," 2023.