Cabergoline - Generic Drug Details

What are the generic drug sources for cabergoline and what is the scope of freedom to operate?

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. Nine 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:	9
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	72
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
Somerset Theraps Llc	CABERGOLINE	cabergoline	TABLET;ORAL	218109-001	Sep 9, 2024	AB	RX	No	No
Actavis Labs Fl Inc	CABERGOLINE	cabergoline	TABLET;ORAL	078035-001	Apr 21, 2008		DISCN	No	No
Strides Pharma Intl	CABERGOLINE	cabergoline	TABLET;ORAL	076310-001	Dec 29, 2005	AB	RX	No	No
Pfizer	DOSTINEX	cabergoline	TABLET;ORAL	020664-001	Dec 23, 1996		DISCN	Yes	No
Impax Labs Inc	CABERGOLINE	cabergoline	TABLET;ORAL	077843-001	Jul 3, 2007		DISCN	No	No
Ivax Sub Teva Pharms	CABERGOLINE	cabergoline	TABLET;ORAL	077750-001	Mar 7, 2007	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 Cabergoline

Last updated: February 19, 2026

What is Cabergoline and How Is It Used?

Cabergoline is a dopamine receptor agonist primarily prescribed for hyperprolactinemia, Parkinson’s disease, and prolactin-secreting pituitary tumors. It is known for its high affinity for D2 receptors. The drug is marketed under brand names including Dostinex and Cabaser. It is available generically in numerous markets, especially outside the U.S.

Market Size and Growth

Global Market Valuation

The worldwide cabergoline market was valued at approximately USD 400 million in 2021. It is projected to expand at a compound annual growth rate (CAGR) of 4.5-6% over the next five years (2022-2027). The growth is driven by increasing prevalence of hyperprolactinemia, expanding indications, and rising generic drug penetration.

Year	Market Size (USD millions)	CAGR (2022-2027)	Notes
2021	400	-	Base year
2022	420	5.0%	Expectations based on current trends
2027	530–560	4.5–6%	Projected range

Regional Market Share

North America dominated with over 45% of the global market, followed by Europe (~30%), Asia-Pacific (~15%), and Rest of World (~10%). Growth rates are highest in Asia-Pacific, driven by increasing healthcare infrastructure and rising diagnosis rates.

Region	Market Share (2021)	Growth Drivers
North America	45%	Advanced healthcare infrastructure, high diagnosis rate
Europe	30%	Aging population, increased awareness
Asia-Pacific	15%	Healthcare expansion, generic drug accessibility
Rest of World	10%	Emerging markets, increasing health expenditure

Drivers of Market Growth

• Increasing prevalence of hyperprolactinemia and Parkinson’s disease. Prevalence of hyperprolactinemia varies from 0.4-5% in the general population, often diagnosed in women of reproductive age.
• Growth in generic drug manufacturing. Multiple companies produce generic cabergoline, contributing to price competition.
• Expanded indications. Off-label uses for restless leg syndrome and other conditions are being explored, potentially broadening market scope.
• Regulatory approvals. Several countries have approved generic formulations, increasing accessibility.

Competitive Dynamics

Patent Landscape

Cabergoline's patent protections have expired or are pending in key markets, enabling generics to enter. No recent new drug applications (NDAs) or exclusivity periods are active in major markets like the U.S. since the original patent expired in the early 2010s.

Key Players

• Eli Lilly (original patent holder for Dostinex)
• Teva Pharmaceuticals (leading generic manufacturer)
• Mitsubishi Tanabe Pharma
• Sandoz (Novartis)

The market is highly competitive, with multinationals leveraging cost advantages through generics.

Pricing Trends

Generic options reduce prices by 30-50%, pressuring margins for branded drugs. Prices for branded cabergoline can range from USD 30-50 per tablet, while generics are available at USD 10-20 per tablet (per unit).

Regulatory Status

Cabergoline’s approval status varies:

• FDA: Approved since 1997 for hyperprolactinemia and Parkinson’s.
• EMA: Approved similar indications.
• Emerging markets: Approval for off-label uses introduces uncertainties and potential growth opportunities.

Financial Trajectory and Investment Opportunities

Revenue Projections

Revenue is expected to grow modestly, driven by increased adoption and generic competition. The revenue contribution from branded formulations may decline while generics fill the gap.

Investment Risks

• Patent expiry; potential for patent challenges or generic entry.
• Regulatory changes; restrictions or new indications could influence sales.
• Pricing pressures; commoditization of generics may reduce profit margins.

Potential Upside

• Development of novel formulations, such as extended-release tablets.
• Expanding into new indications with regulatory support.
• Growth in emerging markets, especially China and India, where healthcare expenditure rises.

Key Takeaways

• The global cabergoline market is valued at USD 400 million (2021), with steady growth driven by increasing diagnosis rates and broader indications.
• The market is highly competitive, with generics significantly influencing pricing and sales.
• North America leads regional sales, but growth is accelerating in Asia-Pacific.
• Revenue growth remains cautious due to patent expiry and price competition but offers opportunities in formulations and emerging markets.
• Regulatory and patent landscapes are evolving, impacting future revenue streams.

FAQs

1. When did the original patent for cabergoline expire?
Patents for cabergoline expired or are close to expiry in major markets such as the U.S. and Europe, facilitating generic entry since the early 2010s.

2. Are there newer drugs competing with cabergoline?
Yes, other dopamine agonists like bromocriptine and newer agents like pramipexole are used for similar indications, though cabergoline's high tolerability and dosing convenience give it a competitive edge.

3. What are the primary indications for cabergoline?
Hyperprolactinemia, Parkinson’s disease, and prolactin-secreting pituitary tumors.

4. How does the price of generic cabergoline compare to branded versions?
Generics typically cost 50-70% less, around USD 10-20 per tablet, compared to USD 30-50 for branded drugs.

5. What are the main growth opportunities?
Expanding indications, formulations such as extended-release tablets, and growth in emerging markets.

References

1. MarketResearch.com. (2022). Global Cabergoline Market report.
2. IMS Health. (2021). Pharmaceutical market analysis.
3. U.S. Food and Drug Administration. (2022). Drug Approval Database.
4. European Medicines Agency. (2022). Drug approval records.
5. IBISWorld. (2022). Generic pharmaceuticals industry report.