ESTROSTEP 21 Drug Patent Profile

When do Estrostep 21 patents expire, and what generic alternatives are available?

Estrostep 21 is a drug marketed by Apil and is included in one NDA.

The generic ingredient in ESTROSTEP 21 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for ESTROSTEP 21

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	229
DailyMed Link:	ESTROSTEP 21 at DailyMed

US Patents and Regulatory Information for ESTROSTEP 21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996		DISCN	Yes	No

Expired US Patents for ESTROSTEP 21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996	4,962,098
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996	5,010,070

International Patents for ESTROSTEP 21

See the table below for patents covering ESTROSTEP 21 around the world.

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

Supplementary Protection Certificates for ESTROSTEP 21

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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
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
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
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 the Pharmaceutical Drug: ESTROSTEP 21

Last updated: August 9, 2025

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Introduction

Estrostep 21, a combined oral contraceptive (COC), has established itself within the reproductive health segment, primarily serving women seeking reliable birth control methods. The product’s market performance hinges on evolving demographics, regulatory landscapes, competitive dynamics, and societal shifts toward women’s health empowerment. This analysis delineates the key market drivers, challenges, and the potential financial trajectory for Estrostep 21 within the broader pharmaceutical and contraceptive sectors.

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Market Overview

Estrostep 21 is a monophasic, combination oral contraceptive featuring a unique hormone formulation aimed at offering effective birth control while addressing common side effects such as acne and ovarian cysts. Its market appeal extends to women seeking hormonal regulation alongside contraception, positioning it within a lucrative segment of the women’s healthcare market.

The global contraceptives market was valued at approximately USD 22.65 billion in 2021, with a compound annual growth rate (CAGR) of roughly 6.4% projected through 2028 (Grand View Research, 2022). The increasing acceptance of hormonal contraceptives, driven by societal acceptance and improved awareness, bolsters demand for products like Estrostep 21.

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Market Dynamics

1. Demographic and Societal Factors

• Population Growth of Reproductive-Age Women: An expanding demographic cohort of women aged 15-49 significantly sustains demand. According to UN data, approximately 1.7 billion women fall within this age group globally, with growth in emerging markets such as Asia-Pacific, Latin America, and Africa presenting a substantial opportunity [1].

• Women’s Health Advocacy: Societal shifts emphasizing reproductive rights and autonomous health choices have normalized contraceptive use. The World Health Organization (WHO) emphasizes the importance of accessible contraception as part of comprehensive women’s health strategies [2].

• Urbanization and Education: Increasing urbanization and educational advancements correlate with higher contraceptive adoption, favoring branded products like Estrostep 21.

2. Regulatory Environment

• Regulatory Approvals: Patent exclusivity and regulatory clearances influence market entry. The expiration of key patents can lead to generic competition, potentially constraining Estrostep 21’s market share but also opening avenues for cost-effective alternatives.

• Reimbursement Policies: Insurance coverage and government reimbursement significantly impact sales. Countries with supportive health policies for contraceptives bolster product adoption.

3. Competitive Landscape

• Brand Competition: Estrostep 21 faces competition from multinational pharmaceutical giants’ contraceptive portfolios, including brands like Yaz, Ortho Tri-Cyclen, and generic entrants. Differentiation through unique formulations or additional benefits (e.g., acne control) can sustain its market position.

• Generic Drugs Surge: The patent cliff has led to increased presence of generics, exerting downward pricing pressure. Cost competitiveness and brand loyalty become critical for Estrostep 21’s sustained sales.

• Alternative Contraceptives: The rise of non-hormonal and long-acting reversible contraceptives (LARCs) such as IUDs and implants diversifies consumer choice, potentially impacting oral contraceptive sales.

4. Innovation and Product Differentiation

• Formulation Improvements: Continuous innovation to reduce side effects (e.g., lower hormone doses) can enhance adherence, shaping a higher-value proposition for Estrostep 21.

• Combination with Other Therapies: Integration with lifestyle or health management initiatives may broaden its appeal.

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Financial Trajectory

1. Revenue Streams and Market Penetration

• Current Market Share: As a branded contraceptive, Estrostep 21 currently captures a niche within the broader COC market. Its success depends on brand loyalty, physician prescribing patterns, and patient preferences.

• Growth Potential: Target markets include North America, Europe, and Asia-Pacific, with Africa and Latin America showing rapid growth due to demographic trends and limited contraceptive alternatives.

• Pricing Dynamics: Premium pricing, supported by its unique benefits, sustains margins in developed markets. Price erosion is anticipated where generics dominate.

2. Impact of Patent Expiration and Generics

• Patent Lifecycles: Most oral contraceptives have patent protections lasting 5-10 years. The expiration of Estrostep 21’s patents could prompt generic competition, resulting in revenue declines.

• Strategic Response: Pharmaceutical companies often respond with line extensions, formulations, and marketing campaigns to prolong brand life.

3. Regulatory and Policy Impacts

• Reimbursement Reforms: Changes in healthcare policies and coverage influence sales volumes. Expansion of access via public health programs directly correlates with increased revenue.

• Global Health Initiatives: Programs aimed at reducing unmet needs for contraception improve product accessibility, especially in low-income settings.

4. Market Share Evolution and Forecasts

• Scenario Analysis:

  • Optimistic Scenario: Continued innovation, expansion into emerging markets, and favorable regulatory environments could sustain a CAGR of 4-6% over the next five years.

  • Pessimistic Scenario: Intensified generic competition, regulatory hurdles, and shifts toward LARCs could limit growth, with revenues plateauing or declining marginally.

• Financial Forecasts: Assuming current market conditions and stabilization of competitive dynamics, Estrostep 21 could experience revenues in the range of USD 200-300 million annually within five years, contingent on successful market penetration and formulary positioning.

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Challenges and Opportunities

Challenges

• Price erosion due to generics
• Competition from long-acting and non-hormonal methods
• Regulatory barriers in emerging markets
• Societal and cultural attitudes influencing contraceptive choice

Opportunities

• Expansion into emerging markets with large reproductive-age populations
• Innovating with combination therapies for broader indications
• Developing extended or modified-release formulations
• Leveraging digital health platforms for patient adherence and education

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Key Takeaways

• Demographic Trends Drive Market Growth: The expanding reproductive-age female population globally underpins steady demand for contraceptives like Estrostep 21, especially in emerging markets.
• Innovation and Differentiation Are Critical: Formulation improvements, addressing side effects, and positioning as a multi-benefit product bolster market share.
• Patent Expiry Influences Revenue Trajectory: Anticipated patent cliffs necessitate strategic product lifecycle management, including line extensions and formulation innovations.
• Competitive Landscape Is Intensifying: Generic proliferation and alternative contraceptive methods pose ongoing challenges, requiring robust branding and data-driven positioning.
• Regulatory and Policy Frameworks Are Pivotal: Reimbursement policies, governmental initiatives, and societal acceptance significantly shape market penetration and revenue potential.

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FAQs

1. How does the patent expiration of Estrostep 21 influence its market performance?
Patent expiration typically allows generic competitors to enter the market, exerting downward pressure on pricing and market share. Companies often respond with line extensions or formulations to maintain revenue streams.

2. What demographic shifts could most benefit Estrostep 21’s sales?
Growth in reproductive-age women, especially in developing regions like Asia-Pacific and Africa, presents significant opportunities due to rising awareness and demand for contraceptives.

3. How do alternative contraceptive options impact Estrostep 21’s market share?
The increasing adoption of long-acting reversible contraceptives (LARCs) such as IUDs and implants may reduce oral contraceptive usage. However, estrostep 21’s multi-benefit profile can retain a dedicated user base.

4. What role do regulatory policies play in Estrostep 21’s financial outlook?
Supportive policies and insurance coverage enhance access and sales, while regulatory hurdles can delay or restrict market entry, impacting revenues.

5. What strategic measures can sustain Estrostep 21’s market presence long-term?
Investing in formulation innovation, expanding into untapped markets, engaging in targeted marketing, and exploring combination therapies can help maintain competitive advantage.

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Sources

[1] United Nations Department of Economic and Social Affairs, "World Population Prospects 2022," https://population.un.org/wpp/
[2] World Health Organization, "Contraceptive Use by Method," https://www.who.int/data/gho/data/themes/family-planning