CABERGOLINE - Generic Drug Details

What are the generic 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, Apotex Corp, Impax Labs Inc, Ingenus Pharms Llc, Ivax Sub Teva Pharms, Norvium Bioscience, Skg Pharma, Somerset Theraps Llc, Strides Pharma, 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:	60
Patent Applications:	6,383
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
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Northwestern University	Phase 4
University of Aarhus	N/A

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
Ingenus Pharms Llc	CABERGOLINE	cabergoline	TABLET;ORAL	204735-001	Aug 1, 2018	AB	RX	No	Yes
Ivax Sub Teva Pharms	CABERGOLINE	cabergoline	TABLET;ORAL	077750-001	Mar 7, 2007	AB	RX	No	No
Actavis Labs Fl Inc	CABERGOLINE	cabergoline	TABLET;ORAL	078035-001	Apr 21, 2008		DISCN	No	No
Skg Pharma	CABERGOLINE	cabergoline	TABLET;ORAL	218618-001	Jun 26, 2024	AB	RX	No	No
Strides Pharma	CABERGOLINE	cabergoline	TABLET;ORAL	076310-001	Dec 29, 2005	AB	RX	No	No
Impax Labs Inc	CABERGOLINE	cabergoline	TABLET;ORAL	077843-001	Jul 3, 2007		DISCN	No	No
Norvium Bioscience	CABERGOLINE	cabergoline	TABLET;ORAL	202947-001	Dec 2, 2013		DISCN	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

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/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

CABERGOLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cabergoline

Market Overview

Cabergoline, a dopamine agonist approved in 1993, is widely used in treating various health conditions, including hyperprolactinemia, Parkinson's disease, and acromegaly. Here’s a comprehensive look at the market dynamics and financial trajectory of cabergoline.

Market Size and Growth

The global cabergoline market is projected to experience steady growth over the coming years. As of 2024, the market size was estimated to be around $7 million, and it is expected to reach $10 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.8% during the forecast period[1][4].

Segmentation

By Type

The cabergoline market is segmented based on purity levels: purity < 95%, purity 95%-98%, and purity > 98%. The purity < 95% segment is anticipated to dominate the market during the forecast period[4].

By Application

Cabergoline is used in treating several conditions, including:

• Hyperprolactinemia: This is the primary indication, driven by the rising incidence of hormonal disorders.
• Parkinson's Disease: Cabergoline is used to manage motor symptoms and reduce the need for levodopa.
• Acromegaly: Ongoing research explores its therapeutic potential for this condition[2][3][4].

By Formulation

The market is divided into branded and generic formulations. The rise of generic options is expected to enhance market accessibility and affordability, driving growth[2][3].

By Distribution Channel

The distribution channels include pharmacies, hospitals, and online platforms. The growth of telemedicine and digital health solutions is also expected to impact distribution dynamics[2].

Market Drivers

Increasing Prevalence of Hyperprolactinemia

The rising incidence of hyperprolactinemia and related endocrine disorders is a significant driver. Lifestyle changes, stress, and environmental factors contribute to hormonal imbalances, increasing the demand for cabergoline[2].

Technological Advancements

Continuous innovation in drug formulations has improved efficacy and patient compliance. New delivery methods and formulations enhance the treatment experience[2].

Regulatory Support

Favorable regulatory frameworks have promoted the approval of cabergoline and its generics, increasing market accessibility[2].

Growing Awareness and Research

Ongoing clinical studies and research initiatives support the therapeutic use of cabergoline, expanding its indications and market potential[2][3].

Market Restraints

Competition from Alternative Treatments

While cabergoline has a favorable side-effect profile, competition from other treatments can impact market growth. However, its effectiveness in managing high prolactin levels maintains its market position[2].

Regulatory and Economic Factors

Variations in regulatory environments and economic conditions across regions can affect the market's growth trajectory. For instance, the budget impact analysis in Brazil showed that adding cabergoline to the formulary would have a significant budget impact, though lower than other treatment options[5].

Regional Insights

Europe

Europe dominates the cabergoline market, driven by advanced research facilities, favorable regulatory environments, and a high prevalence of hormonal disorders. Countries like Germany, France, and the UK are key markets[2][4].

North America

North America is the second-largest market, with the United States being a significant contributor due to its well-established healthcare system and strong regulatory frameworks[2].

Asia-Pacific

The Asia-Pacific region, particularly countries like China and India, is emerging as a promising growth area due to increasing healthcare expenditures and growing awareness of endocrine disorders[2].

Competitive Analysis

Key players in the cabergoline market include:

• Global Biologicals
• Wellona Pharma
• Alven Laboratories
• Salvavidas Pharmaceutical
• Teva API
• Finetech Pharma

These companies are focusing on R&D investments, new product launches, and strategic partnerships to strengthen their market position[1][4].

Future Outlook

The future outlook for the cabergoline market is optimistic. The increasing prevalence of hyperprolactinemia and related disorders, along with advancements in drug formulation and delivery technologies, will continue to drive demand. The rise of generic formulations and growing awareness about hormonal disorders will further expand market accessibility and affordability[2][3].

Financial Trajectory

The financial trajectory of the cabergoline market is characterized by steady growth. Here are some key financial metrics:

• Market Size in 2024: $7 million
• Projected Market Size in 2030: $10 million
• CAGR: 4.8% from 2024 to 2030[1][4].

Budget Impact Analysis

A study in Brazil estimated that adding cabergoline to the formulary for treating Cushing's disease would result in a budget impact of about BRL $6 million over five years, highlighting the financial considerations involved in integrating cabergoline into healthcare systems[5].

Key Takeaways

• The cabergoline market is expected to grow at a CAGR of 4.8% from 2024 to 2030.
• The market is driven by the increasing prevalence of hyperprolactinemia, technological advancements, and favorable regulatory frameworks.
• Europe and North America are the leading regions, with the Asia-Pacific region emerging as a significant growth area.
• Key players are focusing on R&D, new product launches, and strategic partnerships to maintain market competitiveness.
• The rise of generic formulations and growing awareness about hormonal disorders will enhance market accessibility and affordability.

FAQs

What is the expected market size of cabergoline by 2030?

The global cabergoline market is expected to reach $10 million by 2030[1].

What is the CAGR of the cabergoline market from 2024 to 2030?

The cabergoline market is expected to exhibit a CAGR of 4.8% from 2024 to 2030[1][4].

Which regions dominate the cabergoline market?

Europe and North America are the leading regions, with Europe dominating due to advanced research facilities and favorable regulatory environments[2][4].

What are the primary applications of cabergoline?

The primary applications include treating hyperprolactinemia, Parkinson's disease, and acromegaly[2][3][4].

Who are the key players in the cabergoline market?

Key players include Global Biologicals, Wellona Pharma, Alven Laboratories, Salvavidas Pharmaceutical, Teva API, and Finetech Pharma[1][4].

Cited Sources:

1. Global Cabergoline Market Insights, Forecast to 2030 - Valuates Reports
2. Cabergoline Tablets Market Size, Growth and Analysis Report - 2033 - Data Horizon Research
3. Cabergoline Tablets Market Report 2024 (Global Edition) - Cognitive Market Research
4. Cabergoline Market Size, Share, Growth | Forecast, 2032 - Business Research Insights
5. Budget impact analysis of cabergoline for medical treatment of ... - PubMed