DESOGEN Drug Patent Profile

Which patents cover Desogen, and when can generic versions of Desogen launch?

Desogen is a drug marketed by Organon Usa Inc and is included in one NDA.

The generic ingredient in DESOGEN 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 Desogen

A generic version of DESOGEN was approved as desogestrel; ethinyl estradiol by DURAMED PHARMS BARR on August 12^th, 1999.

Summary for DESOGEN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	1
Patent Applications:	4,430
DailyMed Link:	DESOGEN at DailyMed

Recent Clinical Trials for DESOGEN

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

Sponsor	Phase
Oregon Clinical and Translational Research Institute	N/A
Oregon Health and Science University	N/A

See all DESOGEN clinical trials

US Patents and Regulatory Information for DESOGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Usa Inc	DESOGEN	desogestrel; ethinyl estradiol	TABLET;ORAL-21	020071-001	Dec 10, 1992		DISCN	No	No
Organon Usa Inc	DESOGEN	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020071-002	Dec 10, 1992		DISCN	No	No

Expired US Patents for DESOGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Inc	DESOGEN	desogestrel; ethinyl estradiol	TABLET;ORAL-21	020071-001	Dec 10, 1992
Organon Usa Inc	DESOGEN	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020071-002	Dec 10, 1992

International Patents for DESOGEN

See the table below for patents covering DESOGEN around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	367067
Austria	A1032373
Australia	6326373
Belgium	808391
Canada	1021318	11,11-ALKYLIDENE STEROIDS
Switzerland	614453

Market Dynamics and Financial Trajectory for Desogen

Last updated: April 5, 2026

What is Desogen?

Desogen is a combined oral contraceptive containing ethinylestradiol and desogestrel. It is marketed primarily for birth control and menstrual regulation. Its formulation has been available since the late 1990s, with the U.S. FDA approval granted in 1996.

Market Entry and Regulatory Status

Desogen's initial approval by the FDA occurred in 1996, and it has been marketed extensively in the U.S. and globally. It is classified as a prescription drug for contraception. Regulatory hurdles include ongoing post-market surveillance and adherence to labeling requirements in various jurisdictions, but no recent major regulatory shifts have affected its status.

Market Size and Growth Drivers

Global Oral Contraceptives Market

In 2022, the global oral contraceptive market was valued at approximately USD 8.5 billion. It is projected to grow at a compound annual growth rate (CAGR) of around 6% through 2030[1]. Key drivers include:

• Increasing awareness of family planning.
• Growing acceptance of hormonal contraceptives.
• Expanding access in emerging markets.

Desogen's Market Share

While exact market share data for Desogen-specific sales are scarce, combined oral contraceptives (COCs) hold roughly 80% of the total contraceptive market[2]. Within COCs, monophasic formulations like Desogen account for approximately 30-40% of sales, given their ease of use and established safety profile.

Major competitors include:

• Ethinylestradiol/levonorgestrel (e.g., Mircette).
• Ethinylestradiol/drospirenone (e.g., Yasmin).
• Ethinylestradiol/dienogest (e.g., Orgia).

Regional Market Dynamics

North America leads with a 35% share, driven by high acceptance and reimbursement coverage. Europe accounts for approximately 30%, with growth driven by urbanization and awareness. Asia-Pacific is the fastest-growing region, with an expected CAGR of 7% due to increasing healthcare infrastructure and family planning initiatives.

Pricing and Revenue Estimates

Pricing varies across regions. In the U.S., average wholesale prices for a 28-day supply range from USD 150 to USD 250. Assuming steady prescribing volumes—estimated at 25 million monthly prescriptions globally—annual revenues for Desogen could be in the range of USD 1.8 billion to USD 3 billion, depending on market penetration and pricing strategies.

Sales are sensitive to patent status. Desogen is a generic formulation, with numerous licensed generics available, exerting downward pressure on prices. It is also facing increased competition from newer, low-dose formulations and long-acting reversible contraceptives (LARCs).

Patent and Patent Expiry

Desogen's patent expired in 2012 in the U.S., leading to increased generic competition. Market share shifted primarily towards generics supported by established manufacturing and lower pricing. No current patent protections are in effect, which influences revenue trajectory and market margins.

R&D and Pipeline Outlook

There are no recent reports of new formulations or modifications of Desogen in late-stage development. The focus in contraceptive R&D is on:

• Long-acting injectables.
• Reversible implants.
• Non-hormonal options.

Desogen’s market prospects depend on its ability to maintain relevance through provider preference and patient acceptance rather than innovation.

Financial Trajectory

Short-Term Outlook (Next 3 Years)

• Revenue stabilization expected as generic competition remains intense.
• Margins under pressure due to pricing erosion.
• Growth potential limited unless new formulations or delivery methods are introduced.

Long-Term Outlook (Next 5-10 Years)

• Continued decline in revenue share due to increasing popularity of LARCs and non-hormonal methods.
• Market volume likely to plateau or decline marginally.
• Opportunities exist for niche marketing for specific demographics or combination therapies.

Regulatory and Market Risks

• Potential reintroduction of patent protections via new formulations.
• Changes in healthcare reimbursement policies.
• Shifts towards non-hormonal contraceptives reducing demand for traditional hormonal pills.

Key Competitive Factors

• Price competitiveness.
• Prescriber preference.
• Patient compliance and side effect profile.

Conclusion

Desogen's financial prospects hinge on generic market dynamics and the shift towards alternative contraceptive methods. While current revenues are stable, long-term growth faces structural decline driven by competition, innovation in contraceptive technology, and evolving consumer preferences.

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Key Takeaways

• Desogen is a well-established oral contraceptive with no current patent protection.
• The global contraceptive market is growing (~6% CAGR), but Desogen faces commoditization pressures.
• Revenue estimates range from USD 1.8 billion to USD 3 billion annually, with declining margins due to generic competition.
• Pharmacological innovation and changing preferences are critical risk factors for future revenue.
• Market expansion in Asia-Pacific and personalized contraception strategies present growth opportunities.

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FAQs

1. What are the main competitors of Desogen?
Generics of ethinylestradiol/desogestrel and alternative hormonal contraceptives like Yasmin (ethinylestradiol/drospirenone) represent major competition.

2. How does patent expiration affect Desogen’s market?
Patent expiration in 2012 led to increased generic entries, driving prices lower and reducing profit margins.

3. Are there new formulations of Desogen in development?
No significant new formulations or delivery systems are publicly available in late-stage development for Desogen.

4. What is the outlook for Desogen’s market share?
Market share is expected to decline gradually as newer contraceptive options, especially LARCs, gain popularity.

5. How might regulatory changes influence Desogen's future?
Reimbursement policies, approval of non-hormonal methods, or patent reissues could impact sales positively or negatively.

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References

[1] MarketsandMarkets. (2023). Contraceptive Devices Market by Product, User Type, and Region.
[2] Grand View Research. (2022). Oral Contraceptives Market Size, Share & Trends.