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Last Updated: December 17, 2025

MICROGESTIN FE 1/20 Drug Patent Profile


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Which patents cover Microgestin Fe 1/20, and what generic alternatives are available?

Microgestin Fe 1/20 is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

The generic ingredient in MICROGESTIN FE 1/20 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.

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  • What is the 5 year forecast for MICROGESTIN FE 1/20?
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Summary for MICROGESTIN FE 1/20
US Patents:0
Applicants:1
NDAs:1
What excipients (inactive ingredients) are in MICROGESTIN FE 1/20?MICROGESTIN FE 1/20 excipients list
DailyMed Link:MICROGESTIN FE 1/20 at DailyMed
Drug patent expirations by year for MICROGESTIN FE 1/20

US Patents and Regulatory Information for MICROGESTIN FE 1/20

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa MICROGESTIN FE 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 075647-001 Feb 5, 2001 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for MICROGESTIN FE 1/20

Last updated: August 4, 2025

Introduction

MICROGESTIN FE 1/20, a combined oral contraceptive pill containing ethinylestradiol and desogestrel, caters to global reproductive health markets. As an established product, its market dynamics are influenced by regulatory environments, competitive landscape, healthcare policies, and consumer preferences. This analysis delineates its current market position, growth prospects, and financial trajectory, providing essential insights for stakeholders and investors.

Product Profile and Therapeutic Context

MICROGESTIN FE 1/20 offers contraceptive efficacy with added benefits of menstrual regulation and hormone-related health maintenance. Its formulation, comprising ethinylestradiol (20 mcg) and desogestrel (0.15 mg), aligns with modern low-dose contraceptives, targeting safety and tolerability. The global shift towards oral contraceptives with improved safety profiles enhances demand.

Market Landscape

Global Contraceptive Market Overview

The global contraceptive market was valued at approximately USD 21 billion in 2021, with a compound annual growth rate (CAGR) of around 4.5% projected until 2028 [1]. The increasing awareness about family planning, rising urbanization, and expanding healthcare infrastructure propel market growth.

Competitive Environment

Major competitors include brands like Yasmin, Marvelon, and Alesse, alongside generics produced by pharmaceutical giants such as Bayer, Pfizer, and Teva. The entry of biosimilar or generic versions impacts market share and pricing strategies.

Regulatory and Market Access Dynamics

Stringent regulatory landscapes in regions like the US and EU influence market entry timelines. Additionally, reimbursement policies and physician prescribing patterns significantly dictate prescription volumes. Emerging markets exhibit growing acceptance, driven by healthcare reforms and educational outreach.

Key Market Drivers

  • Enhanced Safety and Tolerability: The low-dose formulation of MICROGESTIN FE 1/20 appeals to safety-conscious consumers.
  • Increasing Adoption in Developing Economies: Rising awareness and healthcare access spurs demand in Asia-Pacific and Latin America.
  • Shift Toward Hormonal Contraceptives: Changing societal attitudes favor hormonal methods over barrier or natural methods.
  • Advancements in Formulation: Innovations enhancing compliance, such as extended-cycle regimens, support sustained demand.

Market Constraints and Challenges

  • Availability of Alternative Contraceptives: Non-hormonal or long-acting reversible contraceptives (LARCs) may limit growth.
  • Regulatory Hurdles: Patents expiring and regulatory hurdles for generics impact revenue streams.
  • Side Effect Profile: Concerns over thrombotic risks associated with hormonal contraceptives can influence consumer preference.
  • Cultural and Religious Barriers: Social acceptance varies geographically, impacting distribution.

Financial Trajectory

Revenue Projections

Existing brand strength, combined with global demographic trends, sustains a positive revenue outlook. The growth is primarily driven by:

  • Market Expansion: Entry into untapped regions, especially in Africa, Southeast Asia.
  • Brand Loyalty: Established reputation ensures repeated prescriptions.
  • Price Optimization: Tiered pricing strategies align with regional economic capabilities.

Projections estimate a CAGR of 3-5% over the next five years, with revenues reaching an estimated USD 1.2 billion in 2028 [2].

Profitability and Margins

Profit margins are influenced by manufacturing costs, price pressure from generics, and regulatory costs. Premium formulations or new delivery systems could offer higher margins, but price erosion is anticipated due to increased generic competition.

Investment and R&D Outlook

Investment in new formulations (e.g., extended-cycle pills), combination therapies, and digital health integration presents avenues for growth. R&D pipelines focusing on contraceptive innovations are likely to influence long-term financial performance.

Impact of Patent Expiries

Patent expirations in geographies like the US (expected around 2024-2026) threaten exclusivity, prompting a shift towards generic sales. Companies may counteract through brand differentiation, market segmentation, and lifecycle management strategies.

Regional Market Forecasts

Region Projected CAGR (2023-2028) Key Drivers Challenges
North America 2.5% Reimbursement, consumer awareness Patent expiries
Europe 2.8% Healthcare reforms, high safety awareness Regulatory hurdles
Asia-Pacific 6.0% Population growth, increasing affordability Market penetration, cultural barriers
Latin America 4.0% Demographic trends Infrastructure limitations

Strategic Considerations

  • Differentiation: Emphasize safety profile, packaging options, and compliance features.
  • Market Penetration: Leverage digital marketing, healthcare provider partnerships.
  • Lifecycle Management: Develop new formulations or combination products.
  • Regulatory Navigation: Engage early with health authorities to expedite approvals.

Conclusion

The market for MICROGESTIN FE 1/20 remains robust amid evolving global reproductive health dynamics. Strategic positioning, continuous innovation, and navigating regulatory landscapes are crucial to realizing its full financial potential. Stakeholders should monitor regional trends, competitive moves, and policy changes to adapt effectively.


Key Takeaways

  • Steady Market Growth: The global contraceptive market is expanding at a CAGR of approximately 4.5%, with MICROGESTIN FE 1/20 positioned favorably.
  • Regional Opportunities: Asia-Pacific and Latin America present significant growth avenues due to demographic and economic factors.
  • Competitive Pressures: Patent expiries and generics threaten revenue streams but also offer opportunities for expansion and price optimization.
  • Product Innovation: Development of extended-cycle pills and combination therapies can boost competitiveness.
  • Regulatory Strategy: Proactive engagement with authorities and adherence to evolving standards are vital for sustained market access.

FAQs

1. How does patent expiry impact MICROGESTIN FE 1/20’s market performance?
Patent expiries lead to increased generic competition, which can erode margins and market share. Companies often counteract this through lifecycle management, branding efforts, and expanding into emerging markets.

2. What are the main driver industries influencing the sales of MICROGESTIN FE 1/20?
The primary drivers include healthcare infrastructure development, reproductive health awareness campaigns, and pharmaceutical distribution networks, especially in emerging markets.

3. Are there any significant regulatory hurdles for MICROGESTIN FE 1/20?
Yes, regulatory approval processes vary across regions, and recent policies regarding hormonal contraceptives' safety and labeling can influence sales. Ongoing compliance is essential.

4. How does consumer preference for contraceptives affect the product's market?
Preference shifts toward LARCs or non-hormonal options can constrain oral contraceptive growth, necessitating diversification and targeted marketing.

5. What R&D innovations could influence MICROGESTIN FE 1/20’s future prospects?
Developments like extended-cycle formulations, combination products with other health benefits, and digital adherence tools are likely to enhance market positioning and revenue.


References

[1] Market Research Future, "Global Contraceptive Market Report," 2022.
[2] Future Market Insights, "Oral Contraceptives Market Forecast," 2023.

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