Bromocriptine mesylate - Generic Drug Details

What are the generic sources for bromocriptine mesylate and what is the scope of freedom to operate?

Bromocriptine mesylate is the generic ingredient in three branded drugs marketed by Lek Pharm, Mylan, Zydus Pharms Usa Inc, Esjay Pharma, Aurobindo Pharma Usa, Padagis Us, Sandoz, and Veroscience, and is included in eight NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bromocriptine mesylate has thirty-three patent family members in thirteen countries.

There are eight drug master file entries for bromocriptine mesylate. Seven suppliers are listed for this compound.

Summary for bromocriptine mesylate

International Patents:	33
US Patents:	13
Tradenames:	3
Applicants:	8
NDAs:	8
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	7
Patent Applications:	5,353
Drug Prices:	Drug price trends for bromocriptine mesylate
What excipients (inactive ingredients) are in bromocriptine mesylate?	bromocriptine mesylate excipients list
DailyMed Link:	bromocriptine mesylate at DailyMed

See drug prices for bromocriptine mesylate

Recent Clinical Trials for bromocriptine mesylate

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

Sponsor	Phase
Changchun GeneScience Pharmaceutical Co., Ltd.	PHASE3
Andrew Moshfeghi, MD, MBA	Phase 1/Phase 2
Case Western Reserve University	Phase 1/Phase 2

See all bromocriptine mesylate clinical trials

Pharmacology for bromocriptine mesylate

Drug Class

Ergot Derivative

Medical Subject Heading (MeSH) Categories for bromocriptine mesylate

Antiparkinson Agents

Dopamine Agonists

Hormone Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for bromocriptine mesylate

G02CB	Prolactine inhibitors
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

N04BC	Dopamine agonists
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for bromocriptine mesylate

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			Y
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes			Y
Lek Pharm	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	CAPSULE;ORAL	075100-001	Dec 10, 1998		DISCN	No	No
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes

Expired US Patents for bromocriptine mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009
Esjay Pharma	PARLODEL	bromocriptine mesylate	CAPSULE;ORAL	017962-002	Mar 1, 1982
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009
Esjay Pharma	PARLODEL	bromocriptine mesylate	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982

International Patents for bromocriptine mesylate

Country	Patent Number	Title	Estimated Expiration
South Korea	101593360
Australia	2010256366	Combination of dopamine agonists plus first phase insulin secretagouges for the treatment of metabolic disorders
Mexico	2019003619	FORMULACIONES DE BROMOCRIPTINA. (BROMOCRIPTINE FORMULATIONS.)
Mexico	2019003619	FORMULACIONES DE BROMOCRIPTINA. (BROMOCRIPTINE FORMULATIONS.)

Market Dynamics and Financial Trajectory for Bromocriptine Mesylate

Last updated: July 28, 2025

Introduction

Bromocriptine Mesylate, a dopamine receptor agonist primarily used in Parkinson’s disease, hyperprolactinemia, and acromegaly management, continues to hold significance in the pharmaceutical landscape. Its pharmacological profile and therapeutic applications influence its market dynamics and financial prospects. Understanding the evolving landscape of Bromocriptine Mesylate requires evaluating market drivers, challenges, key players, regulatory influences, and emerging trends.

Market Overview

Bromocriptine Mesylate, marketed under various brand names—including Parlodel, Cycloset, and others—remains a cornerstone in certain neurological and endocrinological treatments. Despite the advent of newer agents, its low-cost profile and established efficacy sustain its market presence, particularly in developing regions.

The global market for dopamine agonists, including Bromocriptine, was valued at approximately USD 1.2 billion in 2021 and is projected to grow at a CAGR of around 4% through 2028, driven by rising Parkinson’s disease prevalence and endocrine disorder treatment needs [1].

Key Market Drivers

1. Growing Prevalence of Parkinson’s Disease and Endocrine Disorders
   The global Parkinson’s disease population is estimated to reach over 14 million by 2040, amplifying demand for dopaminergic therapies such as Bromocriptine. Additionally, increasing diagnoses of hyperprolactinemia and acromegaly—conditions treated with Bromocriptine—are expanding market reach.

2. Cost-Effectiveness and Established Efficacy
   As an established medication with a long safety record, Bromocriptine remains favorable in resource-constrained markets. Its affordability compared to newer therapies incentivizes continued use where cost is a limiting factor.

3. Regulatory Approvals and Off-label Use
   Regulatory approvals across multiple countries facilitate continuous market supply. Additionally, off-label uses—including fertility treatments—drive supplementary demand, though these are less regulated.

4. Emergence of Novel Dopamine Agonists
   Newer agents like pramipexole and ropinirole offer improved side effect profiles, challenging Bromocriptine’s dominance. Nonetheless, Bromocriptine’s affordability sustains its role, especially in markets where newer agents are less accessible.

Market Challenges

1. Adverse Effect Profile
   Bromocriptine’s side effects—including nausea, hypotension, and psychiatric effects—limit tolerability. This drives both prescriber and patient preference toward newer agents with better safety profiles.

2. Patent Expiry and Generic Competition
   Several formulations of Bromocriptine have lost primary patents, resulting in a surge of generic competitors. While this lowers prices, it compresses revenue margins for manufacturers and affects overall financial viability.

3. Regulatory Stringency and Market Access
   Regulatory hurdles and stringency in certain markets, particularly regarding off-label uses or manufacturing standards, can restrain market expansion.

4. Limited Innovation Pipeline
   As a drug discovered several decades ago, Bromocriptine lacks significant innovation or reformulation efforts, potentially limiting its long-term market growth.

Key Players and Competitive Landscape

Major pharmaceutical companies, including Novartis, Baxter, and smaller regional players, manufacture Bromocriptine. The generic segment dominates due to patent expirations, intensifying price competition. Leading players focus on cost optimization and expanding into emerging markets.

Regulatory and Patent Considerations

The initial patent protections for Bromocriptine expired in many jurisdictions during the early 2000s. Subsequent generic entries led to market price declines. Regulatory agencies continue to oversee manufacturing standards, with many countries applying stringent bioequivalence and safety assessments for generics.

Emerging Trends Impacting Financial Trajectory

• Digital and Pharmacovigilance Technologies: The integration of real-time monitoring for adverse effects enhances safety profiles, potentially influencing therapeutic positioning.
• Growing Focus on Personalized Medicine: Tailoring dopamine agonist therapy based on genetic and phenotypic factors may favor newer, targeted agents over Bromocriptine.
• Market Expansion in Emerging Economies: Low-cost formulations maintain relevance in Africa, Asia, and Latin America, providing stable revenue streams despite stiff competition elsewhere.

Financial Outlook

While Bromocriptine’s revenue has plateaued in developed markets due to generic competition and safety concerns, emerging markets present consistent growth opportunities. The global economic outlook, healthcare infrastructure improvements, and rising chronic disease burdens support steady demand.

In the short term, revenues are expected to stabilize or decline modestly in mature markets, with off-label and niche uses providing residual income. Medium to long-term prospects hinge on pharmaceutical companies’ ability to optimize manufacturing costs and penetrate underserved regions.

Conclusion

Bromocriptine Mesylate's market dynamics are characterized by steady demand driven by chronic disease prevalence, cost advantages, and regulatory environments in emerging nations. However, safety concerns, patent expirations, and competition from newer agents pose challenges. Its financial trajectory will depend on strategic market positioning, manufacturing efficiencies, and the capacity to adapt to evolving clinical preferences.

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Key Takeaways

• Steady Demand Amidst Competition: Bromocriptine remains relevant, especially in cost-sensitive markets, due to its established efficacy and affordability.
• Patent Expiry Drives Generic Market Consolidation: Increased competition from generics diminishes profit margins but sustains volume.
• Safety and Tolerability Challenges Limit Growth: The side effect profile curtails its use in regions favoring newer agents.
• Emerging Markets Offer Growth Opportunities: Low-cost formulations facilitate market penetration in Africa, Asia, and Latin America.
• Innovation and Diversification Are Limited: The drug's age and lack of new formulations constrain long-term growth potential.

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FAQs

1. How does Bromocriptine Mesylate compare with newer dopamine agonists in terms of market share?
Newer agents like pramipexole and ropinirole have superior safety profiles and tolerability, leading to increased prescriptions in developed markets. Bromocriptine's market share declines in these regions but remains sizable in emerging markets due to cost advantages.

2. What are the primary therapeutic applications influencing Bromocriptine's market?
Its main uses include Parkinson’s disease, hyperprolactinemia, and acromegaly. Off-label applications, such as fertility enhancement, also contribute to demand.

3. How do patent expirations impact Bromocriptine's financial viability?
Patent expiry has led to a surge in generic versions, resulting in price competition that reduces revenue margins, but enhances volumes, especially in markets with limited access to branded drugs.

4. Are there any recent developments or formulations to extend Bromocriptine's market life?
Limited innovation exists; most companies focus on manufacturing efficiencies and expanding distribution in underserved regions rather than new formulations or delivery systems.

5. What regulatory challenges could influence Bromocriptine’s future marketability?
Regulatory agencies continually evaluate safety profiles; adverse effects may restrict usage or lead to stricter labeling, potentially affecting prescribing patterns and market size.

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References

[1] Research and Markets. "Global Market for Dopamine Agonists," 2022.