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 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:	64
Clinical Trials:	21
Patent Applications:	5,405
DailyMed Link:	DOSTINEX at DailyMed

Recent Clinical Trials for DOSTINEX

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

Sponsor	Phase
Stanford University	Phase 2
Brigham and Women's Hospital	Phase 2
Żelazna Medical Centre, LLC	N/A

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	4,526,892

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/003739 For 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	Withdrawn	no	no	no	2015-12-09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 (Cabergoline)

Overview of DOSTINEX (Cabergoline)

DOSTINEX, known generically as cabergoline, is a long-acting dopamine receptor agonist primarily used for the treatment of hyperprolactinemic disorders and, in some cases, Parkinson's disease. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Size and Growth

The global cabergoline market, which includes DOSTINEX, is projected to exhibit a steady growth trajectory. As of 2024, the global cabergoline market size was estimated to be USD 0.01 billion. This market is expected to maintain its value at USD 0.01 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 4.8% during this period[1].

Driving Factors

Several factors are driving the growth of the cabergoline market:

Increase in Hyperprolactinemia Cases

Hyperprolactinemia, characterized by elevated levels of prolactin in the blood, is a significant health issue that can lead to symptoms such as galactorrhea, amenorrhea, and infertility. The increasing prevalence of hyperprolactinemia due to various causes, including prolactin-secreting pituitary adenomas, is a key driver for the demand of cabergoline[4].

Parkinson's Disease

Cabergoline is also used in the management of Parkinson's disease, particularly in the early stages or as an adjunct to levodopa therapy. The growing number of Parkinson's disease cases contributes to the market growth[4].

Key Players

The cabergoline market is dominated by several key players:

• Teva API
• Finetech Pharma
• Global Biologicals
• Wellona Pharma
• Alven Laboratories
• Salvavidas Pharmaceutical
• Pfizer (through its brand DOSTINEX)[1].

These companies play a crucial role in manufacturing, distributing, and marketing cabergoline, influencing the market dynamics.

Therapeutic Indications and Efficacy

Hyperprolactinemic Disorders

DOSTINEX is highly effective in treating hyperprolactinemic disorders, including conditions such as amenorrhea, oligomenorrhea, anovulation, and galactorrhea. Clinical trials have shown that cabergoline normalizes serum prolactin levels in about 84% of hyperprolactinemic patients, with significant improvements in symptoms like galactorrhea and restoration of menstrual cycles[2][3].

Suppression of Lactation

Cabergoline is also indicated for the suppression of physiological lactation, particularly after delivery, stillbirth, or abortion. It effectively inhibits milk secretion and reduces breast congestion and pain in a high percentage of women[3].

Safety and Monitoring

While cabergoline is effective, its use comes with several safety considerations:

Cardiac Valvulopathy

There have been postmarketing reports of cardiac valvulopathy associated with cabergoline, particularly at higher doses. Patients must undergo regular cardiovascular evaluations, including echocardiograms, to monitor for valvular disease[2].

Fibrotic Disorders

Cabergoline can also lead to fibrotic disorders such as pleural, pericardial, and retroperitoneal fibrosis. Patients with a history of these conditions should not be treated with cabergoline, and those on treatment must be monitored for signs of progressive fibrosis[2].

Other Adverse Effects

Other potential adverse effects include orthostatic hypotension, intense urges to spend money or gamble, and increased sexual urges. Patients should be carefully monitored and advised to report any new or increased uncontrolled behaviors[2].

Market Challenges

Despite its therapeutic benefits, the cabergoline market faces several challenges:

Regulatory Scrutiny

The need for regular monitoring and the potential for serious side effects like cardiac valvulopathy and fibrotic disorders can lead to regulatory scrutiny and stricter guidelines for its use[2].

Competition

The presence of other dopamine agonists and treatments for hyperprolactinemia and Parkinson's disease can create competition in the market, potentially affecting the market share of cabergoline[4].

Financial Trajectory

The financial trajectory of the cabergoline market is characterized by stable growth:

• Current Market Size: USD 0.01 billion as of 2024[1].
• Projected Market Size: USD 0.01 billion by 2032[1].
• CAGR: 4.8% from 2024 to 2032[1].

This stable growth indicates a consistent demand for cabergoline, driven by its efficacy in treating hyperprolactinemic disorders and Parkinson's disease.

Key Takeaways

• The global cabergoline market is expected to grow at a CAGR of 4.8% from 2024 to 2032.
• The market is driven by increasing cases of hyperprolactinemia and Parkinson's disease.
• Key players such as Pfizer, Teva API, and others dominate the market.
• Cabergoline is highly effective in treating hyperprolactinemic disorders but requires careful monitoring due to potential side effects.
• Regulatory scrutiny and competition from other treatments are market challenges.

FAQs

What is the projected market size of the global cabergoline market by 2032?

The global cabergoline market is projected to touch USD 0.01 billion by 2032[1].

What is the CAGR of the cabergoline market from 2024 to 2032?

The cabergoline market is expected to exhibit a CAGR of 4.8% from 2024 to 2032[1].

What are the primary therapeutic indications for cabergoline?

Cabergoline is primarily used for the treatment of hyperprolactinemic disorders and Parkinson's disease[2][4].

Which companies are key players in the cabergoline market?

Key players include Teva API, Finetech Pharma, Global Biologicals, Wellona Pharma, Alven Laboratories, Salvavidas Pharmaceutical, and Pfizer[1].

What are the potential side effects of cabergoline that require monitoring?

Potential side effects include cardiac valvulopathy, fibrotic disorders, orthostatic hypotension, and intense urges to spend money or gamble[2].

Sources

1. Business Research Insights: Cabergoline Market Size, Share, Growth | Forecast, 2032
2. Pfizer: DOSTINEX® cabergoline tablets
3. Pfizer: Dostinex® Cabergoline 0.5 mg tablets Reference Market
4. DrugBank: Cabergoline: Uses, Interactions, Mechanism of Action - DrugBank