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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Questions you can ask:
- What is the 5 year forecast for DOSTINEX?
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- What is Average Wholesale Price for DOSTINEX?
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: | 4,709 |
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 |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
>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 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |