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Last Updated: November 2, 2024

DOSTINEX Drug Patent Profile


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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. Eight 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 29th, 2005.

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Drug patent expirations by year for DOSTINEX
Recent Clinical Trials for DOSTINEX

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

SponsorPhase
Stanford UniversityPhase 2
Brigham and Women's HospitalPhase 2
Żelazna Medical Centre, LLCN/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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 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Withdrawn no no no 2015-12-09
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for DOSTINEX

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

Country Patent Number Title Estimated Expiration
Bulgaria 61058 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.