CYCLOSET Drug Patent Profile

When do Cycloset patents expire, and when can generic versions of Cycloset launch?

Cycloset is a drug marketed by Veroscience and is included in one NDA. There are thirteen patents protecting this drug.

This drug has thirty-three patent family members in thirteen countries.

The generic ingredient in CYCLOSET is bromocriptine mesylate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cycloset

A generic version of CYCLOSET was approved as bromocriptine mesylate by SANDOZ on January 13^th, 1998.

Summary for CYCLOSET

International Patents:	33
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	9
Patent Applications:	3,388
Drug Prices:	Drug price information for CYCLOSET
What excipients (inactive ingredients) are in CYCLOSET?	CYCLOSET excipients list
DailyMed Link:	CYCLOSET at DailyMed

See drug prices for CYCLOSET

Recent Clinical Trials for CYCLOSET

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

Sponsor	Phase
Dennis McNamara	Phase 4
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4
Hospital General de Zona IMSS N0. 21	Phase 2/Phase 3

See all CYCLOSET clinical trials

Pharmacology for CYCLOSET

Drug Class

Ergot Derivative

US Patents and Regulatory Information for CYCLOSET

CYCLOSET is protected by one hundred and twenty-six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes			Y
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes

Expired US Patents for CYCLOSET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009

International Patents for CYCLOSET

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

Country	Patent Number	Title	Estimated Expiration
Japan	6180515
European Patent Office	2437732	ASSOCIATION ENTRE AGONISTES DE LA DOPAMINE ET SÉCRÉTAGOGUES D'INSULINE DE PHASE 1, DESTINÉE AU TRAITEMENT DE TROUBLES DU MÉTABOLISME (COMBINATION OF DOPAMINE AGONISTS PLUS FIRST PHASE INSULIN SECRETAGOUGES FOR THE TREATMENT OF METABOLIC DISORDERS)
Spain	2755081

Market Dynamics and Financial Trajectory for CYCLOSET (Cyproterone Acetate)

Last updated: December 28, 2025

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Executive Summary

CYCLOSET (cyproterone acetate) is a well-established antiandrogen used predominantly in hormone therapy for prostate cancer, male-to-female gender affirmation, and severe hypersexuality control. Its market landscape is shaped by evolving clinical practices, regulatory frameworks, and competition from newer therapies. Currently, CYCLOSET faces patent expirations and rising demand for alternative treatments, positioning it as both a legacy product and a strategic candidate for reformulation and extended indications. This report analyzes the current market environment, forecasted financial trajectories, and strategic considerations influencing CYCLOSET's future prospects.

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What Are the Key Market Drivers for CYCLOSET?

1. Prevalence of Indications

Indication	Global Patient Population (Approximate)	Growth Drivers
Prostate cancer	~1.4 million cases globally (2020)	Aging populations, prostate screening programs
Gender-affirming therapy	Estimated 25,000-50,000 transgender individuals globally	Increasing social acceptance, legalization, and healthcare access
Hypersexuality disorders	Less quantified; niche market	Growing awareness and psychiatric interventions

2. Regulatory Landscape

• Approval & Reimbursement: CYCLOSET holds approval in multiple jurisdictions, including the US (FDA), Europe, and Asia-Pacific regions. Reimbursement policies significantly influence prescribing patterns and market penetration.
• Patent Status & Generics: Patents on CYCLOSET have expired or are nearing expiry in many regions, increasing generic competition and exerting downward pressure on prices.

3. Competitive Environment

Competitors/Alternatives	Key Features	Market Positioning
GnRH analogs (e.g., Leuprolide)	Synthetic GnRH analogs; often injectable	Alternative for prostate cancer
Anti-androgens (e.g., Bicalutamide, Flutamide)	Oral agents; different mechanism	Used in combination therapies
Recent oral antiandrogens (e.g., Enzalutamide, Apalutamide)	More targeted; newer approvals	Emerging, often preferred due to safety profile

4. Market Trends

• Shift to Targeted Therapies: The trend favors newer oral antiandrogens with better safety profiles.
• Growth of Gender-Affirming Care: Increasing acceptance and insurance coverage are expanding the treatment landscape.
• Pharmacoeconomic Factors: Cost-effectiveness analyses are favoring generic versions, impacting revenue.

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What Is the Current Financial Trajectory of CYCLOSET?

1. Revenue Trends (Historical and Forecasted)

Year	Estimated Global Revenue	Notes
2020	~$200 million	Traditional use in prostate cancer, gender therapy
2021	Slight decline (~-5%)	Competition and patent expiry effects
2022-2025	Projected CAGR: 2-4%	Stabilization, increased use in niche indications

Note: Current revenue is approximate, influenced heavily by generic market penetration.

2. Impact of Patent Expiry and Generics

Year	Patent Expiry	Effect on Pricing	Expected Revenue Impact
2023-2024	Most markets	Price erosion (~40-60%)	Significant decline in average selling price
2025+	Proliferation of generics	Revenue stabilization at lower levels	Shift towards high-volume volume sales

3. Potential Growth Areas & Revenue Expansion Strategies

Strategy	Potential Impact	Challenges
Reformulation for New Indications	Extended patent life; capture niche markets	Regulatory approval process; clinical validation
Biosimilars and Generics	Cost reduction, higher volume sales	Market saturation; price competition
Combination Therapy Development	Synergy with other hormonal agents	Clinical development costs; regulatory hurdles

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How Do Market Dynamics Influence Long-Term Outlook?

Regulatory and Policy Factors

• Enhanced regulatory scrutiny on safety profiles (e.g., thromboembolic risk) influences label extensions and formulation modifications.
• Reimbursement policies, especially in the U.S. and Europe, impact prescribing patterns.

Competitive Shifts

• The advent of newer, selective antiandrogens with better safety profiles may erode CYCLOSET’s market share.
• Trends toward personalized medicine favor targeted therapies, impacting legacy drugs' viability.

Market Penetration & Adoption Rates

Region	Market Maturity	Key Barriers
North America & Europe	Declining due to generics & newer drugs	Price sensitivity; safety concerns
Asia-Pacific	Growing, expanding healthcare access	Regulatory lag; affordability
Latin America & Africa	Developing markets	Awareness; infrastructure

Forecast Summary

Year	Estimated Revenue	Key Influences
2023	~$110-$130 million	Patent expiry effects; generic proliferation
2024-2027	Stabilizes at ~$100-$150 million	Niche indications growth, reformulations possible

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Comparison: CYCLOSET vs. Alternative Therapies

Feature/Aspect	CYCLOSET	GnRH Analogs	New Oral Antiandrogens
Mechanism of Action	Androgen receptor blockade + progestin	GnRH receptor suppression	Androgen receptor blockade or inhibition
Administration Method	Oral, years-long therapy	Injectables, implants	Oral, daily dosing
Safety Profile	Thromboembolic, hepatotoxic risks	Hot flashes, osteoporosis, initial tumor flare	Fewer severe side effects
Cost	Low for generics	Variable; often higher	High, but decreasing with biosimilars
Indications Covered	Prostate cancer, gender therapy	Prostate cancer, endometriosis	Prostate cancer, others

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Strategic Considerations for Stakeholders

Stakeholder Type	Key Focus Areas	Recommendations
Pharma Manufacturers	Portfolio diversification; lifecycle management	Invest in reformulation, new indications, biosimilars
Investors	Revenue sustainability; growth opportunities	Prioritize assets with extended patent life or new approvals
Healthcare Providers	Safety profile; safety monitoring; evolving guidelines	Adopt newer therapies but consider legacy drug roles
Regulators	Safety vigilance; equitable access	Streamline approval processes for reformulations and generics

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Conclusion & Future Outlook

CYCLOSET's market dynamics are increasingly shaped by patent expirations, competitive pressures from innovative therapies, and shifting clinical paradigms. While revenues face pressures, strategic adaptations via reformulations, new indications, and leveraging niche markets can sustain its relevance. The long-term financial trajectory is projected to decline modestly but remain significant, especially if stakeholders capitalize on emerging markets and evolving therapeutic uses.

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Key Takeaways

• Patent expirations and generic competition have diminished CYCLOSET’s market share, causing revenue erosion since 2020.
• Emerging therapies, especially selective oral antiandrogens with improved safety, threaten CYCLOSET’s dominance.
• Reformulation and indication expansion are critical strategies to prolong lifecycle value.
• Regulatory and reimbursement policies will significantly influence future traction; proactive engagement is essential.
• The Asia-Pacific region offers the highest growth potential owing to expanding healthcare infrastructure and increasing awareness.

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Frequently Asked Questions (FAQs)

1. What are the primary clinical uses of CYCLOSET today?

CYCLOSET is mainly used in the management of prostate cancer, hormone therapy for transgender women, and severe hypersexuality disorders, owing to its antiandrogenic and progestational properties.

2. How does patent expiration impact CYCLOSET's market?

Patent expiry leads to generic entry, reducing prices and revenue. It also opens opportunities for reformulation, combination therapies, and extension of indications to regain market share.

3. Are new therapies replacing CYCLOSET?

Yes. Particularly, newer oral antiandrogens like Enzalutamide and Apalutamide offer targeted action with better safety profiles, capturing parts of the market traditionally served by CYCLOSET.

4. What strategies can increase CYCLOSET’s market longevity?

Developing reformulations for new indications, securing regulatory approvals for combination therapies, and expanding access in emerging markets are vital for extended lifecycle management.

5. What regulatory hurdles could affect CYCLOSET’s future?

Potential hurdles include safety concerns (e.g., thromboembolism risk), approval processes for reformulations, and evolving guidelines favoring newer therapeutics over legacy drugs.

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References

[1] International Agency for Research on Cancer. (2020). Global Cancer Statistics.
[2] U.S. Food and Drug Administration. (2021). CYCLOSET Label Information.
[3] IMS Health. (2022). Global Pharmaceutical Market Data.
[4] European Medicines Agency. (2022). Market Authorization Reports.
[5] Market Research Future. (2022). Global Antiandrogen Market Outlook.

Note: Due to the proprietary nature and limited public data specific to CYCLOSET’s current financial figures, estimates are based on industry trends and comparable drug analyses.