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Last Updated: December 12, 2025

Desogestrel; ethinyl estradiol - Generic Drug Details


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What are the generic drug sources for desogestrel; ethinyl estradiol and what is the scope of freedom to operate?

Desogestrel; ethinyl estradiol is the generic ingredient in eighteen branded drugs marketed by Avion Pharms, Organon Usa Inc, Duramed Pharms Barr, Janssen Pharms, Lupin Ltd, Aspen Global Inc, Dr Reddys Labs Sa, Naari Pte, Novast Labs, Watson Labs, Xiromed, Ph Health, Aurobindo Pharma, Barr, Teva Branded Pharm, and Glenmark Pharms Ltd, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound.

Summary for desogestrel; ethinyl estradiol
Recent Clinical Trials for desogestrel; ethinyl estradiol

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)PHASE4
Yale UniversityPHASE4
Laboratorios Andromaco S.A.Phase 1

See all desogestrel; ethinyl estradiol clinical trials

US Patents and Regulatory Information for desogestrel; ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd BEKYREE desogestrel; ethinyl estradiol TABLET;ORAL-28 202226-001 Aug 12, 2015 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ph Health KIMIDESS desogestrel; ethinyl estradiol TABLET;ORAL-28 076681-001 Apr 30, 2015 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Organon Usa Inc DESOGEN desogestrel; ethinyl estradiol TABLET;ORAL-21 020071-001 Dec 10, 1992 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Duramed Pharms Barr VELIVET desogestrel; ethinyl estradiol TABLET;ORAL-28 076455-001 Feb 24, 2004 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Dr Reddys Labs Sa DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 076916-001 Dec 29, 2008 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Aurobindo Pharma SIMLIYA desogestrel; ethinyl estradiol TABLET;ORAL-28 206853-001 Mar 22, 2017 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Duramed Pharms Barr DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-21 075256-001 Aug 12, 1999 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

Expired US Patents for desogestrel; ethinyl estradiol

Market Dynamics and Financial Trajectory for Desogestrel and Ethinyl Estradiol

Last updated: November 30, 2025

Executive Summary

Desogestrel combined with Ethinyl Estradiol (EE) is a widely used oral contraceptive, with a significant share in women’s reproductive health products. The global market for combined oral contraceptives (COCs) is projected to grow at a CAGR of approximately 4.2% from 2023 to 2028, driven by increasing awareness of family planning, improving healthcare infrastructure, and expanding developing markets. This report analyzes the current market landscape, key drivers, segment performance, competitive dynamics, and future projections, emphasizing the financial trajectory of desogestrel and EE formulations.


What are Desogestrel and Ethinyl Estradiol?

Component Description Role in Contraceptive Brand Examples
Desogestrel A third-generation progestin, a selective progesterone receptor modulator Prevents ovulation Cerazette (merck), Desogen
Ethinyl Estradiol (EE) A synthetic estrogen used in hormonal contraceptives Suppresses ovulation Yasmin, Yaz, Ortho Tri-Cyclen

Mechanism of Action:
This combination inhibits ovulation, thickens cervical mucus, and alters endometrial lining, reducing pregnancy probability.


Market Overview

Current Market Size and Growth

Metric 2023 Estimate CAGR (2023-2028) Notes
Global market size ~$4.5 billion 4.2% Driven by North America, Europe, and expanding Asia-Pacific
Market segmentation by route Oral capsules (~85%) Predominant form
Leading regions North America, Europe, Asia-Pacific North America: 40%, Europe: 30%, APAC: 20%, Rest of World: 10%

Market Drivers

  • Rising Demand for Family Planning: Driven by demographic trends and contraceptive awareness campaigns.
  • Increasing Female Workforce Participation: Elevates contraceptive needs, especially in emerging economies.
  • Product Innovation: Extended-cycle formulations, lower side-effect profiles expand market reach.
  • Regulatory Approvals: Fast approvals in emerging markets open new revenue sources.

Market Restraints

  • Side Effect Concerns: Including thrombosis risks associated with EE.
  • Patent Expiries: Less restrictive in some markets, leading to increased generic competition.
  • Cultural and Religious Factors: Reproductive choices may limit usage in specific regions.

Competitive Landscape

Key Players and Market Shares

Company Key Products Estimated Market Share Strategic Moves
Bayer AG Yaz®, Yasmin® 35% Innovation in drospirenone-based formulations
Merck & Co. Desogen®, Cerazette 20% Focused on generics and biosimilars
Teva Pharmaceutical Generic Desogestrel/EE formulations 15% Cost leadership, aggressive price strategies
Others Various regional brands 30% Localized formulations, value-based pricing

Market Entry Barriers

  • Regulatory Compliance: Lengthy, costly approval paths.
  • Manufacturing Complexity: Ensuring bioequivalence and quality standards.
  • Brand Loyalty & Trust: Established brands hold significant consumer preference.

Financial Trajectory: Revenue and Pricing Trends

Revenue Breakdown (2023)

Region Revenue (USD Millions) Market Share Key Factors
North America $1,800 40% High contraceptive adoption rates
Europe $1,350 30% Mature market, high generics share
Asia-Pacific $630 14% Growing awareness, expanding markets
Latin America & Africa $450 10% Emerging markets, regulatory improvements

Pricing Dynamics

Formulation Type Average Price per Cycle (USD) Trends Notes
Branded (innovator) $25 - $35 Stable or slight increase Premium pricing due to brand loyalty
Generic formulations $10 - $20 Decreasing due to competition Impacted by patent expiries

Key Revenue Drivers

  • Patent Expiries: Several formulations will face generic competition from 2024 onwards, lowering prices.
  • New Product Launches: Extended-cycle designs and combination pills with reduced estrogen levels.
  • Rise of OTC Sales: Regulatory relaxations in some markets enable Over-The-Counter availability, increasing sales volume.

Regulatory and Policy Landscape

Region Regulatory Agency Recent Policy Changes Implication
U.S. FDA 2020 lifted restrictions on over-the-counter sales for certain contraceptives Increased access; potential revenue boost
EU EMA Emphasis on safety, risk mitigation More stringent safety evaluations
Asia-Pacific Local health authorities Rapid approvals for generics Lower barriers for market entry
Latin America ANVISA, COFEPRIS Evolving contraceptive guidelines Market expansion opportunities

Future Outlook and Market Projections

Growth Drivers Forecast (2023-2028)

Driver Impact Level Expected Outcome
Demographic growth in APAC High Surge in contraceptive demand in India, China, Southeast Asia
Product Innovation Moderate to High Better safety profiles, user-friendly options will expand market
Digital Health Initiatives Emerging Telemedicine and direct-to-consumer channels facilitate access
Regulatory Liberalization Moderate Faster approvals, increased OTC availability

Market Forecast Summary

Year Estimated Global Market Size (USD) CAGR Notes
2023 ~$4.5 billion - Baseline
2025 ~$5.0 billion ~4.0% Growing acceptance, new formulations there
2028 ~$6.0 billion ~4.2% Peer competition, patent expiries influence pricing

Segment Hotspots

  • Generic Market Expansion: Patent cliffs in North America and Europe propel generics, driving volume but compressing margins.
  • Emerging Markets Growth: Asia-Pacific and Latin America present untapped demand, especially with regulatory changes.
  • Product Innovation: Lower-dose EE formulations, extended-cycle pills, and new delivery options.

Comparative Analysis: Desogestrel + Ethinyl Estradiol vs. Alternatives

Aspect Desogestrel + EE Other Hormonal Contraceptives Notes
Efficacy >99% typical use Similar or slightly less Consistent across formulations
Side Effect Profile Thrombosis risk associated with EE Varies; newer low-dose options Lower doses mitigate risks
Cost Moderate to high (branded), low (generic) Similar or lower for generics Price sensitivity influences adoption
User Convenience Once daily, extended options available Multiple formulations possible Extended-cycle options improve adherence
Market Penetration High in developed economies Growing in emerging markets Competitive positioning varies

FAQs

1. What factors could significantly influence the revenue of desogestrel and EE formulations in the coming years?

Answer: Patent expiries leading to increased generic competition, regulatory changes enabling OTC sales, product innovation targeting safety and convenience, and expanding markets in Asia-Pacific and Latin America.

2. How do safety concerns impact the market trajectory for these contraceptives?

Answer: Elevated thrombosis risks linked to EE may constrain growth; however, formulations with lower estrogen doses or alternative progestins can mitigate these concerns, expanding market acceptance.

3. Which regions are expected to drive the highest growth for desogestrel + EE products?

Answer: Asia-Pacific (notably India and China), Latin America, and certain parts of Africa due to demographic trends, regulatory liberalization, and increasing awareness.

4. How is patent expiration affecting the competitive landscape?

Answer: Patent expiries enable generics, leading to price reductions and volume growth, but also intensify price competition for established brands.

5. What are the key strategic considerations for pharmaceutical companies entering this market?

Answer: Navigating regulatory pathways, differentiating through innovative formulations or delivery systems, establishing brand trust, and regionally tailored marketing strategies.


Key Takeaways

  • The global market for desogestrel + EE contraceptives is poised for steady growth driven by demographic trends, product innovation, and expanding access in emerging markets.
  • Patent expiries will catalyze a shift toward generics, impacting pricing strategies but increasing volume sales.
  • Safety profiles, especially concerning thrombosis risks, will influence formulation development and regulatory approvals.
  • Region-specific strategies—considering cultural, regulatory, and economic factors—are critical for market success.
  • Continuous innovation, including extended-cycle and lower-dose formulations, will differentiate products and capture market share.

References

[1] MarketsandMarkets. (2023). Combined Oral Contraceptives Market by Product, Design, End-User, and Region.
[2] Frost & Sullivan. (2022). Global Contraceptive Market Outlook.
[3] U.S. Food and Drug Administration (FDA). (2020). Guidance on OTC Contraceptive Access.
[4] World Health Organization (WHO). (2022). Family Planning and Reproductive Health.
[5] Bloomberg Intelligence. (2023). Pharmaceutical Industry Trends & Analysis.


Note: This report synthesizes current available data and market trends up to Q1 2023. Future projections are subject to change based on technological innovations, regulatory shifts, and socio-economic factors.

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