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. Eight 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:	8
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	6
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
Case Western Reserve University	Phase 1/Phase 2
Andrew Moshfeghi, MD, MBA	Phase 1/Phase 2
VeroScience	Phase 1

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
Esjay Pharma	PARLODEL	bromocriptine mesylate	CAPSULE;ORAL	017962-002	Mar 1, 1982	AB	RX	Yes	No
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

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	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982
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 bromocriptine mesylate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3620155	FORMULATIONS DE BROMOCRIPTINE (BROMOCRIPTINE FORMULATIONS)
Australia	2016202572
Spain	2902573
European Patent Office	3375437	COMBINAISON D'AGONISTES DE LA DOPAMINE ET DE SÉCRÉTAGOGUES D'INSULINE DE PHASE 1 POUR LE TRAITEMENT DE TROUBLES MÉTABOLIQUES (COMBINATION OF DOPAMINE AGONISTS PLUS FIRST PHASE INSULIN SECRETAGOUGES FOR THE TREATMENT OF METABOLIC DISORDERS)

Bromocriptine mesylate Market Analysis and Financial Projection Experimental

Bromocriptine Mesylate Market Dynamics and Financial Trajectory

Introduction to Bromocriptine Mesylate

Bromocriptine mesylate, an ergot alkaloid derivative and a dopamine D2 agonist, is used to manage various medical conditions, including Parkinson's disease, hyperprolactinemia, and type 2 diabetes. Its versatile applications and growing demand are driving significant market growth.

Market Growth and Forecast

The global Bromocriptine Mesylate Reagent Market is projected to experience substantial growth from 2022 to 2028, with a Compound Annual Growth Rate (CAGR) of 10.2% during this period. This growth is fueled by increasing awareness of hormonal disorders, rising demand for effective treatment options, and advancements in pharmaceutical research and development[1][4].

Key Drivers of Market Growth

Advancements in Pharmaceutical Research and Development

The integration of innovative technologies in manufacturing processes is enhancing the quality and availability of bromocriptine mesylate reagents. This has led to the development of novel drug formulations, which are crucial for treating complex conditions like Parkinson's disease and type 2 diabetes[1].

Growing Preference for Personalized Medicine

The trend towards personalized medicine is driving the demand for specialized reagents like bromocriptine mesylate. This approach ensures more targeted and effective treatment options, contributing to the market's robust expansion[1].

Expansion of Healthcare Infrastructures

The expansion of healthcare infrastructures in developing regions is improving access to these critical reagents. This geographical diversification is expected to further boost market growth, especially in regions like North America and Europe, which are anticipated to dominate the market due to their advanced healthcare infrastructure and significant R&D investments[1][4].

Market Segmentation

The Bromocriptine Mesylate Reagent Market is segmented based on several factors:

By Type

• Purity Levels: The market is segmented into different purity levels, such as 98% and 99%, catering to various research and pharmaceutical needs[4].

By Application

• Pharmaceutical Intermediate: Bromocriptine mesylate is used as an intermediate in the production of various pharmaceuticals.
• Research: It is widely used in research settings for studying hormonal disorders and developing new treatments[4].

By Region

• North America: Includes the United States and Canada.
• Europe: Includes Germany, France, the U.K., Italy, and Russia.
• Asia-Pacific: Includes China, Japan, South Korea, India, Australia, and other countries.
• Latin America: Encompasses various countries in Central and South America[1][4].

Major Market Players

Key players in the Bromocriptine Mesylate Reagent Market include:

• Cayman Chemical
• Merck
• Santa Cruz Biotechnology
• Bio-Techne
• Thermo Fisher Scientific

These companies, particularly Bio-Techne and Thermo Fisher Scientific, hold significant market shares due to their diversified product ranges and global distribution networks. Thermo Fisher Scientific's revenue of about $40 billion in 2022 highlights its dominance in the reagents market[1].

Financial Trajectory

The financial outlook for the Bromocriptine Mesylate Reagent Market is promising. Here are some key financial indicators:

Revenue Projections

The market is expected to see significant revenue growth from 2023 to 2031, driven by the increasing demand for bromocriptine mesylate in pharmaceutical and research applications. The market size is measured in USD million across various segments, indicating a substantial expansion during the forecast period[4].

Investment and Funding

Increasing research funding and investments in pharmaceutical research and development are crucial drivers of market growth. These investments are expected to enhance the quality and availability of bromocriptine mesylate reagents, further propelling the market forward[1].

Challenges and Opportunities

Regulatory Hurdles

Despite the positive outlook, the market faces regulatory hurdles that can impact the approval and distribution of bromocriptine mesylate reagents. Navigating these regulatory challenges is essential for market players to ensure uninterrupted growth[1].

Pricing Pressures

Pricing pressures are another challenge, as the market is sensitive to changes in pricing strategies. Companies must balance profitability with affordability to maintain market share and drive growth[1].

Strategic Partnerships and Innovations

Collaborations among pharmaceutical companies and research institutions are accelerating new product developments. These strategic partnerships and innovations are expected to enhance market dynamics and opportunities, driving further growth and expansion[1].

Therapeutic Applications and Market Impact

Type 2 Diabetes

Bromocriptine mesylate has been approved as a supplemental medication for adults with type 2 diabetes to help with glycemic control. Studies suggest that it improves insulin sensitivity and shows promise as an add-on to metformin, although further research is needed to fully assess its efficacy[2].

Neurological Disorders

The drug is also used to manage conditions like Parkinson's disease and hyperprolactinemia. Its effectiveness in these areas contributes significantly to the market's growth, driven by the rising prevalence of neurological disorders[1][2].

Molecular Mechanisms and Research

Research has shed light on the novel anti-diabetic mechanisms of bromocriptine mesylate. It enhances the insulin signaling pathway, reduces inflammatory signals, and exhibits antioxidant capabilities, making it a valuable addition to standard anti-diabetic therapies[5].

Key Takeaways

• Market Growth: The Bromocriptine Mesylate Reagent Market is expected to grow at a CAGR of 10.2% from 2022 to 2028.
• Key Drivers: Advancements in pharmaceutical research, growing preference for personalized medicine, and expansion of healthcare infrastructures.
• Market Segmentation: Segmented by type, application, and region.
• Major Players: Companies like Thermo Fisher Scientific, Bio-Techne, and Merck dominate the market.
• Financial Trajectory: Significant revenue growth projected from 2023 to 2031.
• Challenges and Opportunities: Regulatory hurdles and pricing pressures, but also opportunities through strategic partnerships and innovations.

FAQs

Q: What are the primary therapeutic applications of bromocriptine mesylate?

A: Bromocriptine mesylate is used to manage conditions such as Parkinson's disease, hyperprolactinemia, and type 2 diabetes.

Q: Which regions are expected to dominate the Bromocriptine Mesylate Reagent Market?

A: North America and Europe are anticipated to dominate the market due to their advanced healthcare infrastructure and significant R&D investments.

Q: What are the key drivers of the Bromocriptine Mesylate Reagent Market growth?

A: The key drivers include advancements in pharmaceutical research, the growing preference for personalized medicine, and the expansion of healthcare infrastructures in developing regions.

Q: Who are the major players in the Bromocriptine Mesylate Reagent Market?

A: Major players include Cayman Chemical, Merck, Santa Cruz Biotechnology, Bio-Techne, and Thermo Fisher Scientific.

Q: What are the challenges faced by the Bromocriptine Mesylate Reagent Market?

A: The market faces regulatory hurdles and pricing pressures, but strategic partnerships and innovations offer opportunities for growth.

Sources

1. Bromocriptine Mesylate Reagent Market, Global Outlook and Forecast 2022-2028 Market Analysis and Latest Trends - GitHub
2. Bromocriptine | Treatment & Management | Point of Care - StatPearls
3. Choline Fenofibrate Reagent Sales Market Size, Scope And ... - Market Research Intellect
4. Bromocriptine Mesylate Reagent Sales Market Size, Scope And ... - Market Research Intellect
5. Novel Trajectories of Bromocriptine Antidiabetic Action: Leptin-IL-6 - Frontiers in Pharmacology