You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

CABERGOLINE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Cabergoline patents expire, and when can generic versions of Cabergoline launch?

Cabergoline is a drug 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, and Strides Pharma. and is included in nine NDAs.

The generic ingredient in CABERGOLINE 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 Cabergoline

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

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for CABERGOLINE?
  • What are the global sales for CABERGOLINE?
  • What is Average Wholesale Price for CABERGOLINE?
Summary for CABERGOLINE
Drug patent expirations by year for CABERGOLINE
Drug Prices for CABERGOLINE

See drug prices for CABERGOLINE

Recent Clinical Trials for CABERGOLINE

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

SponsorPhase
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 4
Northwestern UniversityPhase 4
University of AarhusN/A

See all CABERGOLINE clinical trials

Pharmacology for CABERGOLINE
Drug ClassErgot Derivative

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
Actavis Labs Fl Inc CABERGOLINE cabergoline TABLET;ORAL 078035-001 Apr 21, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Skg Pharma CABERGOLINE cabergoline TABLET;ORAL 218618-001 Jun 26, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ingenus Pharms Llc CABERGOLINE cabergoline TABLET;ORAL 204735-001 Aug 1, 2018 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Somerset Theraps Llc CABERGOLINE cabergoline TABLET;ORAL 218109-001 Sep 9, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex Corp CABERGOLINE cabergoline TABLET;ORAL 201503-001 Mar 8, 2013 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.