ESTROSTEP FE Drug Patent Profile

When do Estrostep Fe patents expire, and when can generic versions of Estrostep Fe launch?

Estrostep Fe is a drug marketed by Apil and is included in one NDA.

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

Summary for ESTROSTEP FE

US Patents:	0
Applicants:	1
NDAs:	1
Drug Prices:	Drug price information for ESTROSTEP FE
What excipients (inactive ingredients) are in ESTROSTEP FE?	ESTROSTEP FE excipients list
DailyMed Link:	ESTROSTEP FE at DailyMed

See drug prices for ESTROSTEP FE

US Patents and Regulatory Information for ESTROSTEP FE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996		DISCN	Yes	No

Expired US Patents for ESTROSTEP FE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996

International Patents for ESTROSTEP FE

See the table below for patents covering ESTROSTEP FE around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9203142	CONTRACEPTIVOS DE ESTROGENOS TITULADOS.

Supplementary Protection Certificates for ESTROSTEP FE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124

Market Dynamics and Financial Trajectory for Estrostep FE

Last updated: December 28, 2025

Executive Summary

Estrostep FE, a combined oral contraceptive (COC) formulation comprising ethinylestradiol and norethindrone, targets the hormonal contraception market. This analysis explores the key market drivers, competitive landscape, regulatory factors, and financial forecasts shaping Estrostep FE’s trajectory. The evolving landscape of contraceptive options and demographic trends indicates a nuanced growth path, with potential hurdles linked to market saturation and regulatory shifts. Projected revenues, market share estimations, and strategic insights are provided to guide stakeholders in making informed decisions.

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Introduction

Estrostep FE has maintained a niche position within the oral contraceptive market, primarily marketed for its efficacy and minimal side effects. As access to reproductive healthcare advances globally, and new hormonal therapies emerge, understanding the underlying market dynamics and future financial trends becomes critical.

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Market Overview

Global Hormonal Contraceptive Market (2023-2030)

Parameter	Values / Trends	Source / Notes
Market Size (2023)	USD 17.5 billion	[1]
CAGR (2023-2030)	4-6% Increase	[1]
Leading Regions	North America (35%), Europe (25%), Asia-Pacific (20%)	[2]
Growth Drivers	Rising awareness, accessibility, demographic shifts	[3]

Key Market Segments

Segment	Description	Market Share (%)	Key Players
Combined Oral Contraceptives (COCs)	Primary form; includes Estrostep FE	60%	Bayer, Pfizer, Lupin
Progestin-only pills	Growing due to side effect profile	15%	Allergan, Teva
Non-hormonal contraceptives	Copper IUDs, barrier methods	20%	CooperSurgical, Essure
Long-acting reversible contraceptives (LARCs)	Implants, IUDs	5%	Merck, Bayer

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Market Drivers for Estrostep FE

1. Demographic Trends

• Population Growth & Fertility Rates: Declining fertility in developed nations contrasts with rising youth populations in emerging markets, expanding the potential user base.
• Urbanization & Improved Healthcare Access: Facilitates contraceptive uptake, especially in Asia-Pacific and Africa.

2. Advances in Formulation and Safety Profile

• Reduced Side Effects: Innovations, including estrogen dose optimization, enhance patient compliance.
• Availability of Generic Alternatives: Puts pressure on pricing, but increases overall market penetration.

3. Regulatory Environment

• Approval Pathways: Most markets require rigorous clinical data but increasingly favor oral contraceptive registration.
• Reimbursement & Insurance Coverage: Policies in North America and Europe largely favor contraceptives, supporting market growth.

4. Emerging Markets and Policy Changes

Region	Policy Environment	Market Development
North America	Stable, insurance-covered	Mature, steady growth
Europe	Favorable; some restrictions on hormonal contraceptives	Moderate growth
Asia-Pacific	Expanding access, governmental initiatives	High growth potential
Latin America	Growing middle class, improved healthcare access	Projected increase in demand

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Competitive Landscape

Leading Manufacturers & Market Shares

Manufacturer	Product Portfolio	Estimated Market Share (%)	Strategic Initiatives
Bayer	Yasmin, Yaz, Estrostep FE	25%	Launching next-gen formulations, expanding in Asia
Pfizer	Brand variants, generics	20%	Cost optimization, biosimilars research
Lupin	Generic COCs	15%	Penetrating emerging markets, cost leadership
Others	Various generics and brands	40%	Focus on niche markets and reformulations

Differentiation Factors

• Formulation Efficacy
• Side Effect Profile
• Cost and Accessibility
• Brand Recognition & Physician Preference

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Financial Trajectory of Estrostep FE

Historical Revenue Data (2018-2022)

Year	Estimated Revenue (USD millions)	Notes
2018	200	steady growth in mature markets
2019	220	slight increase, competitive pressures
2020	240	pandemic impact minimal; online sales rise
2021	260	resumption in outpatient sales
2022	280	expansion into emerging markets

Projected Revenue Growth (2023-2030)

Year	Projected Revenue (USD millions)	CAGR (%)	Key Assumptions
2023	300	7.7%	Expansion into India, Brazil; regulatory approvals
2024	322	7.3%	Increased insurance coverage
2025	345	7.0%	Market saturation levels; new formulations launched
2026	370	6.8%	Competitive landscape stabilizes
2027	395	6.7%	Generic competition intensifies
2028	423	6.9%	Diversification into extended-release versions
2029	450	6.4%	Growth driven by emerging markets
2030	480	6.7%	Potential impact of regulatory changes or patent expirations

Revenue Drivers

• Market Penetration: Increased acceptance in emerging markets.
• Formulation Innovation: Reduced side effects, increased compliance.
• Pricing Strategies: Tiered pricing, generic competition.
• Regulatory Approvals: Favorable policies accelerate sales.

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Regulatory and Policy Considerations

Region	Key Regulations	Impact on Estrostep FE	Timeline / Notes
North America	FDA approvals, insurance mandates	Stable, with possibilities for expanded use	Ongoing approval renewals, label expansions
European Union	EMA guidelines, prescription requirements	Moderate barrier, compliance necessary	Market access facilitated through CE marking
Asia-Pacific	Local registration requirements	Fast-tracked in some jurisdictions	Regional partnerships, registration timelines vary
Latin America	Regulatory harmonization efforts	Expected positive trend	Local market-specific formulations

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Comparison with Other Contraceptives

Attribute	Estrostep FE	Yasmin (Bayer)	NuvaRing (Organon)	Implants (Single Rod)
Delivery Method	Oral	Oral	Vaginal ring	Subdermal implant
Efficacy (Typical Use)	99%	99%	99.7%	>99%
Side Effect Profile	Mild, hormonal-related	Similar	Slightly higher risk of hormonal side effects	Low, long-term adherence
Market Positioning	Cost-effective, oral	Brand recognition, innovation	Convenience	Long-term protection, higher upfront cost
Formulation Flexibility	Moderate	Limited	Moderate	Limited

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Forecasted Challenges and Opportunities

Challenges

• Market Saturation: Established brands dominate, limiting growth in mature regions.
• Regulatory Hurdles: Variable approval timelines and restrictions.
• Generic Competition: Pricing pressures and market erosion.
• Consumer Preferences: Shift toward non-hormonal or long-acting methods.

Opportunities

• Emerging Markets: Rapid demographic growth and formal healthcare investments.
• Formulation Innovation: Reduced side effects, extended-release options.
• Healthcare Policy Shifts: Increased insurance coverage and governmental support.
• Digital and Direct-to-Consumer Marketing: Enhancing patient engagement and adherence.

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Key Takeaways

• Steady Growth Prospects: Estrostep FE can expect a CAGR of ~6-8% through 2030, driven by demographic trends and formulation improvements.
• Market Expansion: Opportunities exist predominantly in emerging markets, with regulatory facilitation being critical.
• Competitive Strategy: Differentiation through innovation, cost leadership, and strategic partnerships will be vital.
• Price Sensitivity: Generic competition necessitates flexible pricing strategies to maintain market share.
• Regulatory Vigilance: Staying ahead of approval pathways and policy shifts minimizes market risks.

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Frequently Asked Questions (FAQs)

1. What is the primary market for Estrostep FE?
Estrostep FE primarily targets women of reproductive age seeking oral contraceptive options, with significant demand in North America, Europe, and expanding markets in Asia-Pacific.

2. How does the competition impact Estrostep FE’s market share?
Intense competition from both branded and generic oral contraceptives constrains pricing and market penetration, necessitating continuous innovation and strategic marketing.

3. What regulatory trends could influence Estrostep FE’s future?
Favorable policies in emerging markets, alongside evolving approval processes in developed countries, can present both opportunities and challenges, especially considering potential restrictions on hormonal therapies.

4. Are there any recent formulation advancements for Estrostep FE?
While specific proprietary updates are not publicly disclosed, ongoing research focuses on reduced estrogen doses and extended-release formulations to enhance safety and adherence.

5. What are the key risks for investors in Estrostep FE’s market?
Risks include market saturation, regulatory delays, patent expirations, and increased generic competition, which could suppress revenues and profit margins.

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References

[1] MarketsandMarkets, "Contraceptive Markets," 2022.
[2] ResearchAndMarkets, "Global Hormonal Contraceptives Market Report," 2023.
[3] World Health Organization, "Reproductive Health and Family Planning," 2021.