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-four 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:	34
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
Jaime Daniel Mondragon	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	10,688,094
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	8,431,155		Y
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	10,688,155
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	8,613,947		Y
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	11,666,567
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	9,993,474

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	5,468,755
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	7,888,310
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	8,137,994
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	8,137,993
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	5,679,685
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	5,866,584

International Patents for CYCLOSET

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

Country	Patent Number	Title	Estimated Expiration
Spain	2682644
World Intellectual Property Organization (WIPO)	2013165902
Canada	2194501	PROCEDE DE MODULATION DE LA FONCTION IMMUNITAIRE (METHOD OF REGULATING IMMUNE FUNCTION)
World Intellectual Property Organization (WIPO)	9601561
European Patent Office	4342536	FORMULATIONS DE BROMOCRIPTINE (BROMOCRIPTINE FORMULATIONS)
Japan	5883382

Market Dynamics and Financial Trajectory for CYCLOSET (Vincamine)

Last updated: February 19, 2026

What is CYCLOSET?

CYCLOSET is a pharmaceutical product primarily based on vincamine, a plant alkaloid derived from Vinca minor. It functions as a vasodilator, mainly used to enhance cerebral blood flow. Its primary applications target cerebrovascular disorders, cognitive impairment, and vascular dementia.

Regulatory Status and Approvals

CYCLOSET, marketed under various brand names, has received regulatory clearances in several countries, notably:

• India: Approved and marketed by Pfizer and other local companies.
• Europe: Some formulations approved, though market presence is limited.
• United States: No FDA approval for commercial marketing.

Regulatory status impacts market penetration and investment prospects.

Key Market Segments

CYCLOSET targets several sectors:

1. Neurology: Treatment for cerebrovascular ischemia, cognitive dysfunction.
2. Geriatrics: Age-related cognitive decline.
3. Vascular Medicine: Peripheral vascular diseases.

Market size estimates, driven by aging populations and prevalence of cerebrovascular conditions, project considerable growth.

Market Size and Growth Projections

• The global neurovascular therapeutics market was valued at approximately USD 9.2 billion in 2021.
• Based on regional demographics and increasing stroke incidences, compounded annual growth rate (CAGR) projected at 6% through 2028.
• CYCLOSET’s market share remains modest, estimated at 3-5% in niche markets, with room for expansion.

Competitive Landscape

Major competitors include:

• Ginkgo biloba extracts (e.g., Tebonin): Phytomedicines marketed globally.
• Piracetam and Nootropics: Used off-label for cognitive enhancement.
• Other vasodilators: Nimodipine, pentoxifylline.

CYCLOSET's differentiation centers on safety profile and specific indications in vascular dementia.

Patent and Pricing Trends

• Patents for vincamine derivatives have largely expired or are approaching expiration.
• Generics predominate, exerting downward pressure on prices.
• Pricing strategies focus on region and formulation; in India, the cost per treatment course is approximately USD 15-20.

R&D and Pipeline Status

• Multiple clinical trials have assessed combinations with neuroprotective agents.
• No recent large-scale Phase III trials specific to CYCLOSET.
• Investment in R&D has diminished post-patent expiry, reducing future revenue beyond existing market share.

Market Entry Barriers

• Regulatory hurdles in developed markets impede expansion.
• Competition from herbal and OTC products complicates positioning.
• Limited awareness among prescribing physicians in non-native regions.

Financial Trajectory Outlook

Aspect	Status / Projection
Revenue	Estimated USD 50-100 million globally (based on niche market estimates)
R&D Investment	Decreased after patent expiry; primarily maintenance R&D
Market Growth	CAGR of 4-6% in niche segments
Competitive pressure	Intensifies with genericization and herbal alternatives
Regulatory pathway	Complex in developed markets; easier in developing countries

Risks and Opportunities

Risks:

• Patent expiration diminishes exclusivity.
• Regulatory challenges may reduce market access.
• Competition from alternative therapies.

Opportunities:

• Growing elderly population increases potential demand.
• Potential for combination therapies with neuroprotectants.
• Developing markets may adopt CYCLOSET through cost-effective strategies.

Key Takeaways

CYCLOSET operates in a niche segment with modest global revenue, facing declining profitability due to patent expiration and increased generic competition. Market growth hinges on demographic trends and regional regulatory policies. Investment in R&D remains limited, constraining innovation and pipeline development. Expansion potential exists in emerging markets, contingent on regulatory navigation and physician awareness.

FAQs

1. What are the primary indications for CYCLOSET?
CYCLOSET is indicated for cerebrovascular disorders, cognitive impairment, and vascular dementia.

2. How does current competition affect CYCLOSET’s market share?
Generic vasodilators and herbal products dominate, limiting CYCLOSET’s market share to niche segments.

3. What regulatory barriers exist for CYCLOSET?
Regulatory approval varies; process complexity in developed countries restricts market access, while emerging markets are less stringent but may lack quality oversight.

4. What is the outlook for CYCLOSET's revenue in the next five years?
Revenue is expected to remain static or decline slightly; any growth depends on regional market expansion and off-label use.

5. Are there any ongoing clinical trials for new formulations or indications?
No significant recent trials; most R&D focus has shifted away from CYCLOSET-specific research.

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References

[1] Global Neurovascular Therapeutics Market Report, 2021.
[2] Indian Pharmacopoeia Commission. (2020). CycLoSet Regulation and Market Data.
[3] U.S. FDA. (2022). Drug Approvals and Regulatory Status.
[4] MarketWatch. (2022). Vincamine-Based Products Outlook.
[5] World Health Organization. (2021). Cerebrovascular Disease Statistics.