CYCLOSET Drug Patent Profile

When do Cycloset patents expire, and what generic alternatives are available?

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. Eight 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:	2
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	9
Patent Applications:	3,236
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
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4
Dennis McNamara	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
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	11,000,522

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	8,137,992
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	8,137,993
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	5,866,584
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	5,756,513

International Patents for CYCLOSET

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010141938
Australia	2259092
Austria	391506
Japan	H10502644
Portugal	735863
Australia	2016202572	BROMOCRIPTINE FORMULATIONS
Japan	2015515984	ブロモクリプチン製剤

CYCLOSET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CYCLOSET

Introduction

CYCLOSET, a brand name for bromocriptine mesylate, is a medication used to treat type 2 diabetes. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including investors, healthcare providers, and patients.

Market Context: Oral Anti-Diabetic Drugs

The oral anti-diabetic drugs market is significant and growing, driven by the increasing prevalence of diabetes globally. As of 2024, this market is estimated to be worth USD 46.82 billion and is expected to reach USD 57.44 billion by 2029, growing at a CAGR of 4.17%[4].

CYCLOSET: Clinical Overview

CYCLOSET is approved for the treatment of type 2 diabetes and has been studied extensively in clinical trials. The drug has shown efficacy in improving glycemic control, although it is associated with several adverse events, including gastrointestinal issues, hypoglycemia, and impulse control disorders such as pathological gambling[3].

Market Position and Competition

CYCLOSET operates in a competitive market dominated by other oral anti-diabetic drugs like metformin, DPP-4 inhibitors, and SGLT-2 inhibitors. The market is characterized by a moderate level of fragmentation, with major global players like Eli Lilly, AstraZeneca, and Sanofi, as well as regional players, particularly in the Asia-Pacific region[4].

Sales Performance

Historical sales data for CYCLOSET indicate that the drug has had a relatively stable but modest market presence. For example, in the financial reports of Bausch Health Companies Inc., CYCLOSET generated revenues of $13 million in the fourth quarter of 2020 and $12 million in the fourth quarter of 2021. These figures suggest that while CYCLOSET contributes to the company's revenue, it is not a top-performing product[2][5].

Financial Trajectory

Revenue Trends

The revenue generated by CYCLOSET has been relatively consistent over recent years but has not shown significant growth. This stability can be attributed to its established position in the market and the consistent demand for type 2 diabetes treatments. However, the drug's sales are not as robust as those of other anti-diabetic medications, which may be due to its side effect profile and the availability of alternative treatments[2][5].

Market Forecasts

Detailed sales forecasts for CYCLOSET up to 2020 were provided in a report by GlobalData, which included historical sales data and factors influencing its sales potential. While specific forecasts beyond 2020 are not readily available, the overall trend in the oral anti-diabetic drugs market suggests that CYCLOSET will continue to have a niche presence but may not experience significant growth unless there are significant changes in its market positioning or the introduction of new formulations[1].

Factors Influencing Sales

Several factors influence the sales potential of CYCLOSET:

• Efficacy and Safety: The drug's efficacy in improving glycemic control is a positive factor, but its safety profile, including gastrointestinal adverse events and impulse control disorders, can be a deterrent for some patients[3].
• Pricing: The pricing strategy of CYCLOSET is another critical factor. It must be competitive with other oral anti-diabetic drugs to maintain market share[1].
• Competition: The competitive landscape of the oral anti-diabetic drugs market is intense, with many effective and well-established treatments available. CYCLOSET must differentiate itself through its unique benefits and marketing strategies[4].

Impact of COVID-19

The COVID-19 pandemic has highlighted the importance of glycemic control in improving patient outcomes, which has generally boosted the demand for anti-diabetic medications. However, the specific impact on CYCLOSET sales is not significantly different from the broader market trends, as the drug's sales have remained relatively stable during this period[4].

Conclusion

CYCLOSET, while a viable treatment option for type 2 diabetes, operates in a highly competitive market with modest sales performance. Its financial trajectory is characterized by stability rather than significant growth, influenced by factors such as efficacy, safety, pricing, and competition.

Key Takeaways

• CYCLOSET is part of a growing oral anti-diabetic drugs market, estimated to reach USD 57.44 billion by 2029.
• The drug has a stable but modest market presence with revenues around $12-13 million per quarter.
• Its sales are influenced by efficacy, safety, pricing, and competition within the market.
• The COVID-19 pandemic has generally increased demand for anti-diabetic medications but has not significantly altered CYCLOSET's sales trajectory.

FAQs

What is CYCLOSET used for?

CYCLOSET is used for the treatment of type 2 diabetes to improve glycemic control.

What are the common side effects of CYCLOSET?

Common side effects include gastrointestinal issues such as nausea, hypoglycemia, and impulse control disorders like pathological gambling[3].

How does CYCLOSET compare to other oral anti-diabetic drugs?

CYCLOSET operates in a competitive market dominated by other oral anti-diabetic drugs like metformin, DPP-4 inhibitors, and SGLT-2 inhibitors. It has a niche presence but is not as widely used as some of these other treatments[4].

What is the current market size of oral anti-diabetic drugs?

The oral anti-diabetic drugs market is estimated to be worth USD 46.82 billion in 2024 and is expected to reach USD 57.44 billion by 2029[4].

How has the COVID-19 pandemic affected the sales of CYCLOSET?

The COVID-19 pandemic has generally increased the demand for anti-diabetic medications due to the importance of glycemic control in improving patient outcomes, but it has not significantly altered CYCLOSET's sales trajectory[4].

Sources

1. Research and Markets: "Cycloset (Type 2 Diabetes) - Analysis and Forecasts to 2020"[1].
2. Bausch Health Companies Inc.: "4Q & FY 2021 - Financial Results"[2].
3. FDA: "CYCLOSET® (bromocriptine mesylate tablets), for oral use"[3].
4. Mordor Intelligence: "Oral Anti-Diabetic Drugs Market Size (2024 - 2029)"[4].
5. Bausch Health Companies Inc.: "4Q & FY 2020 - Financial Results"[5].