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Last Updated: December 12, 2025

DESOGESTREL AND ETHINYL ESTRADIOL Drug Patent Profile


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Which patents cover Desogestrel And Ethinyl Estradiol, and when can generic versions of Desogestrel And Ethinyl Estradiol launch?

Desogestrel And Ethinyl Estradiol is a drug marketed by Duramed Pharms Barr, Dr Reddys Labs Sa, Naari Pte, Novast Labs, Watson Labs, and Xiromed. and is included in nine NDAs.

The generic ingredient in DESOGESTREL AND ETHINYL ESTRADIOL is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Desogestrel And Ethinyl Estradiol

A generic version of DESOGESTREL AND ETHINYL ESTRADIOL was approved as desogestrel; ethinyl estradiol by DURAMED PHARMS BARR on August 12th, 1999.

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Summary for DESOGESTREL AND ETHINYL ESTRADIOL
Drug patent expirations by year for DESOGESTREL AND ETHINYL ESTRADIOL
Recent Clinical Trials for DESOGESTREL AND ETHINYL ESTRADIOL

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

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US Patents and Regulatory Information for DESOGESTREL AND ETHINYL ESTRADIOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Novast Labs DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 091234-001 Jul 12, 2013 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-28 075256-002 Aug 12, 1999 AB RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 076915-001 Jul 29, 2005 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
>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 the Pharmaceutical Drug: Desogestrel and Ethinyl Estradiol

Last updated: July 30, 2025


Introduction

The combination of Desogestrel and Ethinyl Estradiol (EE) represents a significant segment within hormonal contraceptives, catering primarily to women seeking effective birth control alongside non-contraceptive benefits such as menstrual regulation. As a well-established oral contraceptive (OC), its market presence is shaped by evolving regulatory landscapes, demographic trends, technological advancements, and competitive forces. This analysis explores the key market dynamics influencing this pharmaceutical segment and projects its financial trajectory over the coming years.


Market Overview and Product Profile

Desogestrel and Ethinyl Estradiol are combined to form a monophasic contraceptive pill. Desogestrel, a third-generation progestin, offers benefits such as reduced androgenic activity, which is associated with lower acne incidence and fewer weight gains. Ethinyl Estradiol, a potent synthetic estrogen, stabilizes the hormonal cycle and enhances contraceptive efficacy.

Global demand for combined oral contraceptives (COCs) remains robust, driven by increased awareness of reproductive health, shifts in societal attitudes towards family planning, and advances in drug formulation. These factors have sustained steady sales figures, with the market evolving to incorporate newer formulations, delivery systems, and safer profiles.


Market Dynamics

1. Demographic and Societal Influences

The global population of women aged 15-49, the primary demographic for contraceptive use, continues to expand, particularly in emerging markets across Asia and Africa. According to United Nations data, this demographic surge signals sustained demand for class products. Urbanization, increasing female workforce participation, and evolving societal attitudes are further fueling the adoption of hormonal contraceptives, including Desogestrel/EE formulations.

2. Regulatory Environment

Approval and regulation of contraceptive pills vary across regions, influencing market accessibility. North American, European, and Asian regulatory agencies have generally maintained a favorable stance towards combined hormonal contraceptives, provided safety profiles are acceptable. Notably, recent scrutiny over cardiovascular risks linked to third-generation progestins prompted regulatory agencies to recommend risk management protocols but did not significantly diminish overall market access.

3. Competition and Innovation

The market is highly competitive, with key players including Pfizer (e.g., Marvelon), Bayer (e.g., Yaz), and Teva. Innovative formulations such as extended-cycle pills, low-dose variants, and refillable delivery systems like patches and vaginal rings are challenging traditional pills. Additionally, the advent of progestin-only pills presented alternatives for women contraindicated for estrogen use.

4. Patent Status and Generic Entry

Patent expirations for several branded Desogestrel/EE products have enabled generic manufacturers to enter the market, exerting downward pressure on prices and expanding access. Generic entrants benefit from lower R&D costs and regulatory pathways, intensifying price competition.

5. Adoption of Non-Oral Delivery Systems

Non-oral contraceptives—like implants, intrauterine devices (IUDs), patches, and vaginal rings—are gaining popularity, especially in developed markets due to improved convenience and fewer systemic side effects. While these do not directly replace oral pills, they influence consumer preferences and market share distribution.


Financial Trajectory

1. Market Size and Growth Projections

The global contraceptive market, valued at approximately USD 19 billion in 2022, is projected to grow at a CAGR of 6% through 2030, driven by increasing demand in Asia-Pacific and Africa. The combined hormonal contraceptive segment, which includes Desogestrel/EE, accounts for a significant portion of this expansion.

In developed markets, mature demand sustains steady revenues, but growth is offset by generic competition reducing profit margins. Conversely, emerging markets present higher growth opportunities, with affordability and awareness driving increased adoption.

2. Revenue Drivers and Margins

Branded formulations typically command higher margins owing to brand loyalty and perceived quality. However, patent cliffs have led to erosion in these margins. Generic entry lowers prices but widens access, ultimately expanding volume sales. Manufacturers investing in differentiation strategies—such as extended-release formulations—aim to maintain higher margins.

3. Impact of Regulatory and Safety Trends

Safety concerns regarding third-generation progestins and estrogen-related adverse effects influence formulary decisions and patient acceptance, potentially impacting sales volume. Drug safety monitoring and pharmacovigilance programs are crucial for maintaining market confidence and avoiding costly legal liabilities.

4. Price Trends and Market Penetration

Price competition driven by generics pushes unit prices downward over time. In some regions, government tenders and reimbursement policies cap prices, affecting revenue streams. Market penetration strategies focus on expanding access through partnerships with government health schemes and insurance providers.

5. Strategic Opportunities

  • Product Differentiation: Developing formulations with improved safety profiles, fewer side effects, or convenient delivery methods.

  • Geographic Diversification: Investment in emerging markets with high growth potential.

  • Regulatory Navigation: Streamlining approval processes in new regions through clinical trials and compliance.

  • Market Education: Increasing awareness regarding contraceptive options and dispelling myths.


Key Market Trends Shaping the Future

  • Personalized Medicine: Tailoring hormonal contraceptives based on genetic and metabolic profiles could redefine product development.

  • Digital and Telehealth Integration: Enhancing access to contraceptive consultation and adherence monitoring through digital platforms.

  • Policy and Reimbursement Dynamics: Potential regulatory moves to include contraceptives in national health schemes may open new avenues in publicly funded markets.

  • Sustainability Initiatives: Eco-friendly packaging and sustainable manufacturing practices are gaining importance, impacting branding and procurement.


Forecast and Strategic Outlook

Looking ahead, the Desogestrel/EE contraceptive market will likely experience modest growth, around 4-6% annually, facilitated by market diversification, technological innovation, and expanding access in underserved regions. Consolidation among pharmaceutical players may narrow portfolios but also foster innovation and cost efficiencies.

Emerging markets, notably India, Indonesia, and parts of Africa, stand as high-growth zones due to demographic factors and increasing healthcare expenditure. Meanwhile, innovations in delivery systems may cannibalize traditional pill sales but also open new segments—especially for women seeking discreet, long-acting, or non-invasive options.

Pharmaceutical companies with robust R&D pipelines, strategic geographic positioning, and adaptive marketing strategies are poised to capitalize on these trends. Companies that proactively address safety concerns and embrace digital health initiatives will likely outperform.


Key Takeaways

  • Steady Demand with Regional Variability: The global market for Desogestrel/EE contraceptives remains stable, with growth concentrated in emerging markets driven by demographic and socioeconomic factors.

  • Intense Price Competition: Patent expirations and generic proliferation decrease profit margins but expand access, favoring volume over premium pricing.

  • Innovation as a Differentiator: Formulation improvements, extended-release variants, and alternative delivery systems are critical to maintaining relevance in a competitive landscape.

  • Regulatory and Safety Risks: Navigating safety concerns and complying with regional regulations are essential to sustaining market presence.

  • Strategic Market Penetration: Focused investment in underserved markets, digital health integration, and product diversification are key pathways to growth.


FAQs

1. How does patent expiry influence the market for Desogestrel/EE contraceptives?
Patent expiries open markets to generic manufacturers, leading to significant price reductions and increased accessibility. While this boosts overall sales volume, it diminishes profit margins for brand-name products.

2. What are the main competitive threats facing Desogestrel/EE products?
Competitors include other combined oral contraceptives with different progestins or formulations, non-oral methods like implants and IUDs, and newer delivery systems such as patches and vaginal rings, which may offer enhanced convenience or safety profiles.

3. How are regulatory changes impacting the market?
Regulatory agencies’ safety reviews—particularly concerning third-generation progestins—have led to updated prescribing guidelines. While these impact product formulations' marketability, they also promote safer prescribing practices, maintaining industry credibility.

4. What emerging markets hold the most promise?
Asia-Pacific, Africa, and Latin America exhibit high growth potential owing to demographic trends, rising healthcare infrastructure, and increasing approval of contraceptive methods.

5. What strategic moves can pharmaceutical companies adopt to enhance their position?
Investing in product innovation, expanding into high-growth regions, adopting digital health strategies, and actively managing safety profiles improve market positioning and financial performance.


References

  1. United Nations Department of Economic and Social Affairs. "World Population Prospects 2022."
  2. MarketWatch. "Contraceptive Market Size, Share & Trends Analysis Report" (2022).
  3. IQVIA. "Global Trends in Contraceptive Product Sales," 2023.
  4. FDA and EMA regulatory updates on hormonal contraceptives, 2021–2022.
  5. Allied Market Research. "Hormonal Contraceptives Market Forecast, 2022–2030."

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