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Last Updated: December 12, 2025

MICROGESTIN 1.5/30 Drug Patent Profile


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When do Microgestin 1.5/30 patents expire, and what generic alternatives are available?

Microgestin 1.5/30 is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

The generic ingredient in MICROGESTIN 1.5/30 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.

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Summary for MICROGESTIN 1.5/30
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors:5
DailyMed Link:MICROGESTIN 1.5/30 at DailyMed
Drug patent expirations by year for MICROGESTIN 1.5/30

US Patents and Regulatory Information for MICROGESTIN 1.5/30

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 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 075548-002 Jul 30, 2003 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 1.5/30

Last updated: July 30, 2025


Introduction

MICROGESTIN 1.5/30, a combined oral contraceptive (COC) containing 1.5 mg of norethindrone and 30 mcg of ethinyl estradiol, occupies a significant niche within the global hormonal contraceptive market. As a progestin-ethinyl estradiol combination, it addresses the contraceptive needs of women worldwide, with rising demand driven by broader acceptance of hormonal birth control, improved awareness, and increased female workforce participation. This analysis delineates the current market dynamics and projects MICROGESTIN 1.5/30's financial trajectory amid evolving healthcare landscapes.


Market Overview: Scope and Size

The global contraceptive market was valued at approximately USD 20 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 5% through 2028. The demand for oral contraceptives, particularly combined pills, dominates this space, propelled by advancements in drug formulations, marketing, and regulatory approvals. MICROGESTIN 1.5/30, being a well-established formulation, benefits from these growth drivers, especially in emerging markets where contraceptive access is expanding.

Beyond traditional markets in North America and Europe, Asia-Pacific, Latin America, and Africa are exhibiting increased uptake of oral contraceptives. Governments in these regions are endorsing family planning initiatives and including contraceptive options like MICROGESTIN 1.5/30 in public health programs, further fueling market growth.


Key Market Drivers Influencing MICROGESTIN 1.5/30

1. Rising Global Demand for Family Planning:
Global demographic shifts and urbanization have increased awareness about reproductive health. The World Health Organization estimates that over 1.1 billion women worldwide use some form of contraception, and oral contraceptives constitute a significant share.

2. Advancements in Drug Formulation and Compliance:
Microgestin’s formulation offers favorable ease of use, minimal side effects, and high efficacy—factors that influence patient compliance. Innovations in packaging and dosing have further enhanced its marketability.

3. Regulatory Approvals and Inclusion in Public Health Programs:
Regulatory bodies—such as the FDA, EMA, and various counterparts—approve and endorse MICROGESTIN 1.5/30, boosting confidence among prescribers and consumers. Inclusion of such drugs into government procurement and family planning schemes expands accessible markets.

4. Growing Focus on Reproductive Rights and Women's Health:
Societal shifts towards empowering women through accessible contraception options have increased demand. Policies advocating reproductive rights underpin the market's expansion.

5. Competitive Landscape and Market Penetration:
Though multiple brands and formulations compete, MICROGESTIN 1.5/30's established clinical profile and patent stability in certain jurisdictions offer it a competitive edge.


Market Challenges and Threats

1. Patent and Regulatory Dynamics:
While some formulations enjoy patent protection, generic competition—particularly from local manufacturers in cost-sensitive markets—poses revenue risks. Regulatory delays or restrictions in new markets can also hinder penetration.

2. Preference for Non-Oral Contraceptives:
In some markets, long-acting reversible contraceptives (LARCs), such as intrauterine devices (IUDs) and implants, are gaining traction, potentially reducing oral contraceptive prescriptions.

3. Cultural and Religious Opposition:
In specific regions, cultural taboos or religious beliefs restrict contraceptive use, limiting market expansion.

4. Competing Products and Evolving Formulations:
Emerging contraceptive options, including hormonal patches and implants with different delivery mechanisms, challenge the dominance of traditional pills.


Financial Trajectory: Revenue and Profitability Outlook

1. Revenue Forecasts:
Based on current market penetration and growth prospects, MICROGESTIN 1.5/30 is poised for steady revenue increases. Assuming the global contraceptive market grows at a 5% CAGR, and MICROGESTIN maintains a 10% share in its category (considering brand loyalty, clinical efficacy, and formulary preferences), revenues could approximate USD 300–500 million over the next five years.

2. Cost Structure and Margin Opportunities:
Manufacturing efficiencies and economies of scale may lead to margin expansion, with profit margins potentially increasing from an average of 20-25% to over 30% in high-volume markets. Licensing agreements and regional partnerships could further boost profitability.

3. Strategic Initiatives Supporting Growth:
Pharmaceutical companies focusing on expanding distribution channels, enhancing consumer awareness, and entering emerging markets will influence MICROGESTIN’s financial trajectory positively. Investment in new formulations or combination therapies may also diversify revenue streams.

4. Impact of Patent Expiry and Generic Competition:
In jurisdictions where patents expire, generic manufacturers will likely disrupt pricing and market share, pressing MICROGESTIN's pricing power downward but potentially increasing overall volume sales.

5. Market Challenges Impacting Revenue Stability:
Preference for alternative contraceptive methods and socio-cultural barriers could temper growth projections, necessitating adaptive strategies like product differentiation or targeted marketing.


Regulatory and Competitive Landscape

The regulatory environment influences MICROGESTIN 1.5/30’s market performance. Its approval status across major regions—North America, Europe, Asia-Pacific—is generally stable, with some markets experiencing delays or specific restrictions. Competitive pressures include generic entrants, which often lead to price reductions but also open avenues for volume growth.

Global players such as Bayer, Pfizer, and Teva produce comparable formulations, intensifying market competition. Differentiators like clinical data, safety profiles, and patient adherence programs will shape MICROGESTIN’s market share trajectory.


Conclusion

The market dynamics for MICROGESTIN 1.5/30 are characterized by steady growth propelled by increasing reproductive health awareness, expansion into emerging markets, and ongoing innovations. While challenges such as patent cliffs and alternative contraceptive methods exist, strategic positioning, regulatory compliance, and market expansion can sustain favorable financial trajectories. With conservative estimates projecting growth in revenues and margins over the next five years, MICROGESTIN remains an integral component within the reproductive health portfolio.


Key Takeaways

  • Market Growth Drivers: Rising contraceptive awareness, international family planning initiatives, and regulatory approvals support sustained demand for MICROGESTIN 1.5/30.

  • Revenue Potential: Anticipated moderate growth, with revenues potentially reaching USD 300–500 million within five years, contingent on market expansion and competitive positioning.

  • Competitive Landscape: Patent expirations and generic competition necessitate differentiation via safety, efficacy, and strategic marketing.

  • Regional Opportunities: Emerging markets present significant growth avenues, especially where contraceptive access is expanding through government support.

  • Strategic Focus: Investment in clinical research, formulation innovation, and regional partnerships will be critical to capitalize on market opportunities and mitigate risks.


FAQs

1. How does the market for MICROGESTIN 1.5/30 compare to other oral contraceptives?
MICROGESTIN 1.5/30 benefits from a well-established clinical profile and brand loyalty, positioning it competitively among oral contraceptives. However, generic options and alternative formulations like patches or LARCs are influencing its market share growth.

2. What are the primary regional growth areas for MICROGESTIN?
Emerging markets in Asia-Pacific, Latin America, and Africa offer substantial growth potential due to increasing contraceptive acceptance, governmental support, and expanding healthcare infrastructure.

3. How do patent expiries impact the financial outlook for MICROGESTIN?
Patent expiries can lead to generic competition, reducing prices but potentially increasing volume sales. Strategic differentiation and cost-efficiency measures are essential to maintaining profitability.

4. What role do regulatory approvals play in the success of MICROGESTIN?
Regulatory approvals facilitate market entry and penetration. Stable and timely approval processes underpin revenue stability and provide a competitive advantage.

5. Can innovations in contraceptive technology affect MICROGESTIN's market share?
Yes. Advances such as long-acting reversible contraceptives or new delivery systems may reduce reliance on oral pills, challenging MICROGESTIN’s dominance unless adaptations or new formulations are developed.


Sources:

  1. MarketWatch. “Global Contraceptive Market Report,” 2022.
  2. WHO. “Family Planning and Contraceptive Use,” 2023.
  3. IQVIA. “Global Pharmaceutical Market Trends,” 2022.
  4. Company Annual Reports and Public Disclosures.
  5. Industry Analysis Reports.

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