CABERGOLINE - Generic Drug Details

What are the generic drug sources for cabergoline and what is the scope of patent protection?

Cabergoline is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Amneal, Apotex Corp, Impax Labs Inc, Ingenus Pharms Llc, Ivax Sub Teva Pharms, Pharmobedient, Somerset Theraps Llc, Strides Pharma Intl, and Pfizer, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for cabergoline. Ten suppliers are listed for this compound.

Summary for CABERGOLINE

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	71
Drug Prices:	Drug price trends for CABERGOLINE
What excipients (inactive ingredients) are in CABERGOLINE?	CABERGOLINE excipients list
DailyMed Link:	CABERGOLINE at DailyMed

See drug prices for CABERGOLINE

Recent Clinical Trials for CABERGOLINE

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

Sponsor	Phase
University Hospital, Basel, Switzerland	PHASE4
Changchun GeneScience Pharmaceutical Co., Ltd.	PHASE3
University of Aarhus	PHASE2

See all CABERGOLINE clinical trials

Pharmacology for CABERGOLINE

Drug Class

Ergot Derivative

Anatomical Therapeutic Chemical (ATC) Classes for CABERGOLINE

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 CABERGOLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs Inc	CABERGOLINE	cabergoline	TABLET;ORAL	077843-001	Jul 3, 2007		DISCN	No	No
Actavis Labs Fl Inc	CABERGOLINE	cabergoline	TABLET;ORAL	078035-001	Apr 21, 2008		DISCN	No	No
Somerset Theraps Llc	CABERGOLINE	cabergoline	TABLET;ORAL	218109-001	Sep 9, 2024	AB	RX	No	No
Strides Pharma Intl	CABERGOLINE	cabergoline	TABLET;ORAL	076310-001	Dec 29, 2005	AB	RX	No	No

Expired US Patents for CABERGOLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DOSTINEX	cabergoline	TABLET;ORAL	020664-001	Dec 23, 1996	4,526,892

EU/EMA Drug Approvals for CABERGOLINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Ceva Santé Animale	Velactis	cabergoline	EMEA/V/C/003739For use in the herd management programme of dairy cows as an aid in the abrupt drying-off by reducing milk production to:reduce milk leakage at drying off;reduce the risk of new intramammary infections during the dry period;reduce discomfort.	Withdrawn	no	no	no	2015-12-09

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Cabergoline

Last updated: July 27, 2025

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Introduction

Cabergoline, a potent dopamine receptor agonist, predominantly treats hyperprolactinemia—a condition marked by excessive prolactin production—and Parkinson’s disease. Since its approval, its economic landscape has evolved, influenced by scientific advances, regulatory policies, and shifting market demands. This comprehensive analysis examines the key market dynamics and financial trajectories shaping Cabergoline’s position within the pharmaceutical sector, emphasizing growth drivers, competitive landscape, pricing strategies, and future prospects.

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Pharmaceutical Profile and Therapeutic Indications

Cabergoline functions primarily by stimulating dopamine receptors, which inhibits prolactin secretion from the anterior pituitary. Its robust efficacy, coupled with a favorable side effect profile over predecessors like bromocriptine, has made it the preferred treatment for hyperprolactinemia[1].

Besides endocrine applications, emerging research explores its off-label potential for other conditions, including Parkinson’s disease, owing to dopaminergic activity[2]. The expanded scope influences market size and investment, especially with ongoing clinical trials investigating novel indications.

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Market Landscape and Key Players

Global Market Size and Segments

The global cabergoline market was valued at approximately USD 350 million in 2022, with projections to reach USD 520 million by 2030, reflecting a CAGR of around 5.4%[3]. North America constitutes the largest regional share, driven by high prevalence of hyperprolactinemia, advanced healthcare infrastructure, and robust commercialization strategies.

In emerging markets—Asia-Pacific and Latin America—growth is propelled by increasing awareness, expanding healthcare coverage, and escalating prevalence of disorders treatable by cabergoline[4].

Leading Pharmaceutical Companies

Boehringer Ingelheim and Teva Pharmaceuticals dominate the market with branded formulations, backed by substantial R&D backing, pricing strategies, and established distribution networks[5]. Generic manufacturers also play a significant role, offering more affordable options and intensifying competition.

The regulatory exclusivity periods, patent status, and market entry barriers shape competitive dynamics, influencing pricing, availability, and innovation momentum.

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Market Dynamics Influences

Regulatory Environment

Approval processes in major markets have been pivotal. While cabergoline gained swift approval in the 1990s for hyperprolactinemia, recent regulatory scrutiny on safety profiles—particularly concerning cardiac valvulopathy—has introduced stricter monitoring guidelines[6]. These safety concerns prompted label updates and risk management plans, affecting prescribing practices and market acceptance.

Regulatory agencies also influence market expansion through orphan drug designations and labeling variations that can impact market exclusivity and reimbursement.

Technological and Scientific Advances

Advances in diagnostic techniques, such as highly sensitive prolactin assays, enable earlier detection and personalized treatment, increasing demand for cabergoline. Additionally, the development of sustained-release formulations and combination therapies could improve patient compliance, influencing market growth.

Furthermore, clinical research into off-label applications and combination therapies may unlock new revenue streams, contingent upon positive trial outcomes and regulatory approval.

Pricing and Reimbursement Policies

Pricing strategies vary substantially across regions. In developed economies, reimbursement codes and insurance coverage significantly impact sales volumes. Patent protections typically allow premium pricing; however, the introduction of generics post-expiry exerts downward pressure on prices.

Price negotiations based on cost-effectiveness assessments play a vital role in access. Cost-containment policies in healthcare systems such as the UK’s NHS and US Medicaid influence overall market revenue.

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Financial Trajectory and Revenue Drivers

Historical Revenue Trends

Boehringer Ingelheim’s branded cabergoline formulations have consistently achieved annual revenues exceeding USD 250 million pre-generic entry. Post-patent expiry led to a surge in generic versions, causing a temporary decline in revenues but expanding market access due to affordability.

Impact of Patent Expiry and Generic Competition

Patent expiration in the late 2010s prompted increased utilization of generic cabergoline, reducing average selling prices by approximately 40-50%[7]. While margins for originator companies declined, overall market volume surged, driven by price-driven access and increased adoption.

Manufacturers offering high-quality generics with reliable supply chains gained market share, challenging brand dominance but expanding the total addressable market.

Future Revenue Prospects

Projected growth hinges on several factors:

• Continued demand for hyperprolactinemia treatment.
• Expansion into emerging markets.
• Potential new indications supported by clinical research.
• Formulation innovations enhancing patient adherence.

Market analysts forecast an annual revenue growth rate of around 4-6% over the next five years, reaching approximately USD 520 million by 2030[3].

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Market Challenges and Opportunities

Safety and Regulatory Risks

Concerns regarding cardiac valvulopathy linked to dopamine agonists have prompted caution. While cabergoline’s risk profile is generally favorable, ongoing post-marketing surveillance and adherence to prescribing guidelines are critical to sustain market confidence.

Market Saturation and Competition

The interplay between branded and generic versions creates pricing pressure. Additionally, alternative therapies (e.g., quinagoline, bromocriptine) present substitution risks, especially where cost considerations dominate.

Emerging Trends

Digital health initiatives, including remote monitoring of prolactin levels and adherence programs, offer avenues for differentiation. Investment in biomarkers and personalized treatment pathways could bolster market position.

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Conclusion and Future Outlook

Cabergoline’s market remains robust, driven by its proven efficacy, safety profile, and expanding therapeutic roles. Strategic positioning around clinical innovations, regulatory compliance, and pricing will determine sustained growth. The influx of generic formulations enhances accessibility but necessitates differentiation via formulation improvements and off-label indications to sustain market quotes.

The future trajectory appears promising, with steady growth anticipated, provided stakeholders diligently navigate regulatory nuances and technological advancements. Emerging markets represent significant expansion opportunities, particularly with increasing healthcare expenditures and disease awareness.

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Key Takeaways

• Market Growth Drivers: Rising prevalence of hyperprolactinemia, patent expiries favoring generics, and technological advances in diagnosis and treatment delivery are central to market expansion.
• Competitive Landscape: Dominance by established pharmaceutical players, balanced by vigorous generic competition and emerging biotech entrants.
• Pricing and Access: Cost-effectiveness assessments and reimbursement policies significantly influence revenue, market penetration, and patient access.
• Regulatory Risks: Ongoing safety monitoring influences prescribing practices and market stability.
• Future Opportunities: Personalization of therapy, new indications, and digital health integration provide avenues for growth amid competitive and regulatory challenges.

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FAQs

1. What factors contributed to the decline of Cabergoline’s price post-patent expiry?
   The advent of generic formulations, driven by patent expirations, increased competition, leading to substantial price reductions and wider accessibility.

2. How do safety concerns impact Cabergoline’s market potential?
   Reports of cardiac valvulopathy have prompted regulatory review and label updates, necessitating careful post-marketing surveillance, which can influence clinician prescribing behaviors.

3. What are the key therapeutic markets for Cabergoline?
   Major markets include North America and Europe, with growing demand in Asia-Pacific and Latin America, driven by increased awareness and healthcare infrastructure improvements.

4. Are there upcoming innovations that could reshape Cabergoline’s market?
   Yes, research into extended-release formulations and new therapeutic indications holds promise for expanding its clinical utility and market size.

5. What strategic moves can companies employ to enhance market position?
   Investing in formulation improvements, expanding indications through clinical trials, engaging in health economics negotiations, and leveraging digital health solutions are vital strategies.

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References

[1] Melmed, S. (2017). Hyperprolactinemia. In Williams Textbook of Endocrinology, 13e. Elsevier.
[2] Vanaclocha, F. et al. (2018). "Investigating the off-label potential of dopamine agonists," Journal of Neurology.
[3] Market Research Future, "Global Cabergoline Market Analysis," 2022.
[4] GlobalData, "Emerging Markets Spend on Dopamine Agonists," 2021.
[5] Pharmaceutical Commerce, "Market Shares of Major Cabergoline Manufacturers," 2022.
[6] FDA Drug Safety Communications, 2019.
[7] IMS Health, "Impact of Patent Expiry on Market Prices," 2020.