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. Six 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.
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: | 5,393 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for DOSTINEX
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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.
ISSN: 2162-2639
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