BROMOCRIPTINE MESYLATE Drug Patent Profile

Which patents cover Bromocriptine Mesylate, and when can generic versions of Bromocriptine Mesylate launch?

Bromocriptine Mesylate is a drug marketed by Lek Pharm, Mylan, Zydus Pharms Usa Inc, Aurobindo Pharma Usa, Padagis Us, and Sandoz. and is included in six NDAs.

The generic ingredient in BROMOCRIPTINE MESYLATE 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 Bromocriptine Mesylate

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

Summary for BROMOCRIPTINE MESYLATE

US Patents:	0
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Patent Applications:	3,479
Drug Prices:	Drug price information 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
Lek Pharm	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	CAPSULE;ORAL	075100-001	Dec 10, 1998		DISCN	No	No
Aurobindo Pharma Usa	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	TABLET;ORAL	076962-001	Sep 24, 2004		DISCN	No	No
Mylan	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	CAPSULE;ORAL	077226-001	Apr 4, 2005	AB	RX	No	Yes
Zydus Pharms Usa Inc	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	CAPSULE;ORAL	078899-001	Jul 30, 2008	AB	RX	No	No
Sandoz	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	TABLET;ORAL	074631-001	Jan 13, 1998	AB	RX	No	No

Market Dynamics and Financial Trajectory of Bromocriptine Mesylate

Last updated: February 20, 2026

What is Bromocriptine Mesylate?

Bromocriptine mesylate is a dopamine receptor agonist primarily used to treat Parkinson’s disease, hyperprolactinemia, acromegaly, and type 2 diabetes. It was first approved by the FDA in 1978 and is marketed under the brand names Parlodel, Cycloset, and others. Its mechanism involves stimulating dopamine receptors, suppressing prolactin secretion, and managing hormonal imbalances.

Regulatory Status and Patent Landscape

Patent Timeline

• Original patents for bromocriptine expired in the late 1990s to early 2000s in most countries.
• Generic manufacturing dominates; no active patents protect bromocriptine mesylate currently.
• Brand name products, such as Parlodel, continued under patent exclusivity until patent expiration.

Regulatory Approvals

• Approved by the FDA for Parkinson’s, hyperprolactinemia, acromegaly, and menstrual disorders.
• Approved in Europe, Japan, and other markets, following similar indications.

Market Drivers

Growing Indications

• Parkinson’s disease prevalence increasing due to an aging population.
• Rising awareness and diagnosis of hyperprolactinemia and acromegaly.
• Development of formulation improvements and combination therapies.

Market Penetration

• Existing presence in long-term treatment protocols.
• Moderate penetration in emerging markets; growth potential exists with access to healthcare infrastructure.

Competitive Landscape

• Dominated by generic manufacturers with low-cost options.
• Limited innovation in bromocriptine formulations; focus on biosimilars is minimal or absent.

Pricing and Reimbursement

• Price points are generally low due to generic competition.
• Reimbursement policies are favorable in developed markets, making it accessible.

Market Challenges

Side Effects and Limitations

• Nausea, orthostatic hypotension, and psychiatric symptoms limit tolerability.
• Patients on long-term therapy face adherence issues.

Market Saturation

• Patents expired over 20 years ago, leading to market saturation with generics.
• Minimal new product innovation or differentiation.

Regulatory and Patent Barriers

• Lack of new formulations due to expired patents.
• No significant regulatory hurdles for generics.

Financial Trajectory

Revenue Estimates

• Global revenue for bromocriptine mesylate products estimated at approximately $100-150 million annually.
• Declining trend since patent expiry, but stabilized by brand loyalty in certain indications.

Market Share

Segment	Estimated Global Market Share	Notes
Generics	~85%	Dominates due to low-cost manufacturing
Branded	~15%	Maintains niche in specific markets

Future Outlook

• Market saturation likely persists with minimal growth.
• Growth potential limited to emerging markets or niche indications.
• Biosimilar development is unlikely due to the nature of the compound.

Investment Considerations

• Minimal R&D expenditure due to expired patents.
• Stable cash flow from established generics.
• Potential shifts if new indications or delivery methods emerge.

Regional Market Overview

Region	Market Size (USD millions)	Growth Rate (CAGR 2023-2028)	Key Drivers
North America	50-70	1-2%	Established healthcare infrastructure, high adoption of generics
Europe	30-50	1-2%	Aging population, regulatory support
Asia-Pacific	10-30	4-6%	Increasing healthcare access, growth in diagnosis of target conditions
Rest of World	10	0-3%	Emerging markets, lower penetration

Key Takeaways

• Bromocriptine mesylate market sustains primarily through generic products.
• Revenue has plateaued or slightly declined due to market saturation.
• No current pipeline of new formulations or indications is evident.
• Growth in emerging markets presents the primary opportunity.
• Price sensitivity and clinical tolerability issues constrain market expansion.

FAQs

1. Are there any patented formulations of Bromocriptine Mesylate?
No. Patents expired in the late 1990s to early 2000s, leading to widespread generic manufacturing.

2. What are the main competitors?
Generic versions dominate; no significant branded competitors remain. Biosimilars are unlikely due to the drug’s chemical nature.

3. How can the market grow despite patent expiry?
Growth potential exists via access to emerging markets and expanded indications, but overall growth remains limited.

4. What are key barriers to market expansion?
Tolerability issues, market saturation, and lack of formulation innovation.

5. Is there potential for new indications?
Currently, no. The drug’s core indications are well-established, with little ongoing R&D for new uses.

References

1. U.S. Food and Drug Administration. (1978). Parlodel (bromocriptine mesylate) approval history.
2. MarketResearch.com. (2023). Global bromocriptine market analysis.
3. IMS Health. (2022). Generic drug market share report.
4. European Medicines Agency. (2021). Pharmacovigilance report on bromocriptine.
5. Whitaker, M. (2020). Trends in Parkinson’s medications. Journal of Clinical Pharmacology.