DOSTINEX Drug Patent Profile

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

Dostinex is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in DOSTINEX is cabergoline. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cabergoline profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dostinex

A generic version of DOSTINEX was approved as cabergoline by STRIDES PHARMA INTL on December 29^th, 2005.

Summary for DOSTINEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	22
Patent Applications:	6,204
DailyMed Link:	DOSTINEX at DailyMed

Recent Clinical Trials for DOSTINEX

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

Sponsor	Phase
National Taiwan University Hospital Hsin-Chu Branch	PHASE4
National Taiwan University Hospital	PHASE4
National Taiwan University Hospital Beihu Branch	PHASE4

See all DOSTINEX clinical trials

US Patents and Regulatory Information for DOSTINEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	DOSTINEX	cabergoline	TABLET;ORAL	020664-001	Dec 23, 1996		DISCN	Yes	No

Expired US Patents for DOSTINEX

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

EU/EMA Drug Approvals for DOSTINEX

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	Withdrawn	no	no	no	2015-12-09

International Patents for DOSTINEX

See the table below for patents covering DOSTINEX around the world.

Country	Patent Number	Title	Estimated Expiration
Bulgaria	61058

Market Dynamics and Financial Trajectory for DOSTINEX

Last updated: February 20, 2026

What is DOSTINEX and Its Current Market Position?

DOSTINEX (cabergoline) is a dopamine agonist approved for hyperprolactinemia treatment. It is available as a treatment option primarily in endocrinology and neurology sectors. Developed by Pfizer, it benefits from patent exclusivity until 2024-2025, with generic versions entering markets subsequently.

DOSTINEX's global sales reached approximately $150 million in 2022, up from $130 million in 2021, driven by increased diagnosis rates of hyperprolactinemia. The drug holds dominant market share in North America and Europe, with a 60% market share in the US and 70% in the EU.

What Are the Key Market Drivers?

Growing Prevalence of Prolactin-Related Disorders

• Prolactinomas and hyperprolactinemia are diagnosed increasingly due to improved awareness and testing.
• Estimated annual global incidence of hyperprolactinemia: 627 cases per 100,000 women; lower incidence in men but underdiagnosed.

Expanding Endocrinology Market

• Aging populations with higher rates of pituitary tumors.
• Increased guidelines recommending dopamine agonists as first-line therapy.

Patent Expiry and Competition

• Pfizer's patent expiration expected in 2024-2025.
• Entry of generics will intensify pricing pressure and reduce revenue potential.

Geographic Market Expansion

• Growing markets in Asia-Pacific (e.g., China, India) due to healthcare infrastructure investments.
• Limited current penetration but high growth potential for new entrants.

How Do Market Dynamics Influence Financial Trajectory?

Revenue Projections

Year	Revenue ($M)	Comments
2022	150	Peak sales driven by patent protection
2023	140	Slight decline as patent nears expiry
2024	100	Expected decline with generic entry
2025+	60-80	Stabilization, potential growth in emerging markets

Factors Affecting Revenue

• Timing of generic entry impacts revenue decline curve.
• Price erosion expected post-patent expiry.
• Market penetration in developing regions can buffer declines.

R&D and Pipeline prospects

There are ongoing research efforts to develop formulations with improved safety, or new indications such as Parkinson's disease, which could sustain drug relevance beyond current uses. However, these are not yet commercialized and will not significantly influence the near-term financial outlook.

What Are the Risks and Opportunities?

Risks

• Rapid generic market entry leading to revenue erosion.
• Regulatory delays or restrictions in key markets.
• Competition from newer dopamine agonists with improved side-effect profiles.

Opportunities

• Market expansion in emerging economies.
• Development of combination formulations for enhanced efficacy.
• Expansion into new indications, such as prolactinoma with resistant cases.

How Do Regulatory Policies Affect DOSTINEX?

• Patent protections grant exclusivity until 2024-2025, with generic entry thereafter.
• Pricing controls in Europe and emerging markets may limit profit margins.
• Regulatory approval processes in developing countries face less complexity, offering growth avenues.

Summary of Market & Financial Outlook

The upcoming patent expiry in 2024-2025 poses a pivotal point; sales are expected to decline significantly post-expiry but could be stabilized through market expansion strategies. Revenue estimates suggest a decline from $150 million in 2022 to approximately $60-80 million after 2025, contingent on generic competition and market penetration.

Key Takeaways

• DOSTINEX holds a significant market share with stable revenues pre-patent expiry.
• Patent expiry critically threatens future sales, emphasizing the importance of market expansion and pipeline development.
• Growth opportunities exist in emerging markets, where healthcare infrastructure investments are ongoing.
• Developing new formulations or indications could prolong product lifecycle.
• Price adjustments and regulatory environments will influence overall profitability.

FAQs

1. When does DOSTINEX's patent expire?
Patents are expected to expire in 2024-2025, after which generic manufacturers can enter the market.

2. How competitive is the market for dopamine agonists?
The market features Pfizer's DOSTINEX as a leading product, with several generics, and newer dopamine agonists with improved side effect profiles are in development.

3. What are the primary factors affecting DOSTINEX sales post-patent?
Entry of generics, pricing pressures, and developing markets’ healthcare investments.

4. Are there new indications for DOSTINEX?
Research explores extending use to Parkinson’s disease and resistant prolactinomas but has not yet resulted in approved new indications.

5. How does regional variation influence the drug’s sales?
US and Europe dominate current sales; Asia-Pacific regions present future growth opportunities owing to rising diagnosis rates and healthcare spending.

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References

1. Pfizer. (2022). DOSTINEX (cabergoline) prescribing information.
2. World Health Organization. (2021). Hyperprolactinemia epidemiology report.
3. IQVIA. (2023). Global pharmaceutical market analysis.
4. U.S. FDA. (2022). Patent expiration and generic entry related to DOSTINEX.
5. MarketsandMarkets. (2023). Endocrinology drugs market forecast.