Cabergoline - Generic Drug Details
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What are the generic drug sources for cabergoline and what is the scope of freedom to operate?
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, Strides Pharma, Welding, 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: | 6,203 |
| Drug Prices: | Drug price trends for cabergoline |
| What excipients (inactive ingredients) are in cabergoline? | cabergoline excipients list |
| DailyMed Link: | cabergoline at DailyMed |
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 |
Pharmacology for cabergoline
| Drug Class | Ergot Derivative |
Anatomical Therapeutic Chemical (ATC) Classes for cabergoline
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | DOSTINEX | cabergoline | TABLET;ORAL | 020664-001 | Dec 23, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Welding | CABERGOLINE | cabergoline | TABLET;ORAL | 218109-001 | Sep 9, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Norvium Bioscience | CABERGOLINE | cabergoline | TABLET;ORAL | 202947-001 | Dec 2, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Strides Pharma | CABERGOLINE | cabergoline | TABLET;ORAL | 076310-001 | Dec 29, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex Corp | CABERGOLINE | cabergoline | TABLET;ORAL | 201503-001 | Mar 8, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax Labs Inc | CABERGOLINE | cabergoline | TABLET;ORAL | 077843-001 | Jul 3, 2007 | DISCN | No | 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 cabergoline
| 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 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 |
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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.
ISSN: 2162-2639
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