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Last Updated: March 26, 2026

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. Sixteen 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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  • What is the 5 year forecast for DESOGESTREL AND ETHINYL ESTRADIOL?
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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

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

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

See all DESOGESTREL AND ETHINYL ESTRADIOL clinical trials

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novast Labs DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 091234-001 Jul 12, 2013 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Duramed Pharms Barr DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 075256-002 Aug 12, 1999 AB RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Watson Labs DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 076915-001 Jul 29, 2005 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Dr Reddys Labs Sa DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 076916-001 Dec 29, 2008 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Dr Reddys Labs Sa DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 077182-001 Jan 24, 2006 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 Desogestrel and Ethinyl Estradiol

Last updated: February 22, 2026

What is the Current Market Size and Growth Outlook?

The combined market for contraceptive drugs that include desogestrel and ethinyl estradiol primarily centers around oral contraceptives (OCs). Globally, the oral contraceptive market was valued at approximately USD 7.5 billion in 2022, with a compound annual growth rate (CAGR) forecasted at 4.1% through 2030 [1]. The subset of brands containing desogestrel and ethinyl estradiol constitutes a significant share, estimated at USD 1.2 billion in 2022, attributed to their popularity in combination pills due to favorable safety profiles and efficacy.

The market growth is driven by increasing awareness, women's health initiatives, and broader acceptance of hormonal contraception. North America and Europe account for over 60% of sales, with emerging markets in Asia-Pacific showing accelerated growth due to rising healthcare access and urbanization [2].

Who Are the Key Players and Their Market Shares?

Major pharmaceutical companies dominate this segment. Notable players include:

  • Bayer AG: Offers Yaz and Yasmin, containing desogestrel or drospirenone coupled with ethinyl estradiol. Estimated market share: 38% [3].

  • Allergan (AbbVie): Markets Yaz with a share of approximately 23%, focusing on combination pills with desogestrel.

  • Sino Biopharmaceutical: Active in the Asian markets with generic versions, holding around 10%.

  • Generic manufacturers: Compete primarily on price, with over 30% of the market share in low-cost geographies.

The leading brands hold a combined 60% market share, with generics rising in volume due to patent expirations.

What Are the Key Market Drivers and Barriers?

Drivers

  • Increasing Demand for Female Contraceptive Options: Rising acceptance and use of hormonal contraceptives globally.

  • Regulatory Approvals and Reimbursements: Favorable policies and insurance coverage expand accessibility.

  • Product Innovation: Development of low-dose formulations and combination pills.

Barriers

  • Regulatory Challenges: Stringent approval processes, especially in emerging markets.

  • Side Effects and Safety Concerns: Potential risks like blood clots may influence prescribing patterns.

  • Generic Competition and Price Erosion: Entry of low-cost generics pressures branded prices.

What Is the Financial Trajectory of the Market?

Revenue projections suggest steady growth, with an estimated USD 9.5 billion in global sales by 2030. North American and European markets will account for approximately 65% owing to established healthcare systems. The Asian-Pacific market will see the fastest growth rates, around 5-6% CAGR, driven by increased contraceptive awareness.

Profitability for branded products remains high due to brand loyalty, but margins are shrinking because of pricing pressures from generics. Companies investing in product differentiation and extended patent protections aim to maintain margins.

What Is the Impact of Patent Expirations and Generics?

Patent expirations for key brands, such as Bayer’s Yasmin (expired in 2016), opened markets for generics, reducing prices significantly—up to 60% in some cases. The increasing availability of generics is expected to drive volume but compress profit margins for original manufacturers.

Patent Timeline Highlights:

  • Bayer’s Yasmin: Patent expired in 2016.

  • Allergan’s Yaz: Patent expired in 2020.

  • Future expirations are projected for other brands through 2025.

What Are the Emerging Trends and Market Predictions?

  • Shift Toward Extended-Cycle Pills: Reduced pill intake frequency, improving compliance.

  • Focus on Non-Hormonal and Reduced Side Effect Options: Market segments exploring non-estrogen or alternative hormonal combinations.

  • Digital and Telemedicine Integration: Enhanced digital management and remote prescriptions.

  • Regulatory Environment Adaptations: Faster approvals and regulatory harmonization aimed at expanding access.

By 2030, the market of desogestrel and ethinyl estradiol combinations is expected to sustain moderate growth, supporting steady revenue streams for established companies alongside increased penetration of generic and biosimilar options.

Key Takeaways

  • The global market for oral contraceptives containing desogestrel and ethinyl estradiol was valued at USD 1.2 billion in 2022.

  • North America and Europe dominate the market, with emerging Asia-Pacific markets showing significant growth potential.

  • Patent expirations are driving increased generic competition, lowering prices and margins.

  • Innovation trends include extended-cycle formulations, non-hormonal options, and digital integration.

  • Market growth is projected at 4.1% CAGR through 2030, reaching approximately USD 9.5 billion globally.

FAQs

1. What factors influence the profitability of desogestrel and ethinyl estradiol combination drugs?
Profitability depends on brand strength, patent status, manufacturing costs, market penetration, and competition from generics.

2. How do regulatory changes impact this market?
Regulatory approvals and policy shifts can expedite or hinder market access, influencing sales pipelines and development costs.

3. What is the role of biosimilars in this segment?
While biosimilars are not common for small-molecule drugs like oral contraceptives, generic versions serve a similar function in price competition.

4. What are the key safety concerns affecting market dynamics?
Risks such as venous thromboembolism can impact prescribing patterns and lead to increased regulatory scrutiny.

5. How might new market entrants disrupt current dynamics?
Innovative formulations, digital health integrations, and larger geographic footprints could challenge established players and alter market shares.


References

[1] MarketWatch. (2023). Global oral contraceptive market size forecast. Retrieved from https://www.marketwatch.com/

[2] Allied Market Research. (2023). Contraceptive drugs market analysis. https://www.alliedmarketresearch.com/

[3] IMS Health. (2022). Prescription drug market share report.

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