NOLVADEX Drug Patent Profile
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Which patents cover Nolvadex, and when can generic versions of Nolvadex launch?
Nolvadex is a drug marketed by Astrazeneca and is included in one NDA.
The generic ingredient in NOLVADEX is tamoxifen citrate. There are sixteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nolvadex
A generic version of NOLVADEX was approved as tamoxifen citrate by ACTAVIS LABS FL INC on February 20th, 2003.
Summary for NOLVADEX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 75 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | NOLVADEX at DailyMed |
Recent Clinical Trials for NOLVADEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Translational Breast Cancer Research Consortium (TBCRC) | Phase 2 |
| Eli Lilly and Company | Phase 2 |
| Jose Pablo Leone | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for NOLVADEX
US Patents and Regulatory Information for NOLVADEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | NOLVADEX | tamoxifen citrate | TABLET;ORAL | 017970-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | NOLVADEX | tamoxifen citrate | TABLET;ORAL | 017970-002 | Mar 21, 1994 | 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 NOLVADEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | NOLVADEX | tamoxifen citrate | TABLET;ORAL | 017970-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca | NOLVADEX | tamoxifen citrate | TABLET;ORAL | 017970-002 | Mar 21, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NOLVADEX
See the table below for patents covering NOLVADEX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| United Kingdom | 1064629 | ⤷ Try a Trial | |
| France | 6841 | ⤷ Try a Trial | |
| Denmark | 118655 | ⤷ Try a Trial | |
| Switzerland | 441286 | Verfahren zur Herstellung von Alkenderivaten | ⤷ Try a Trial |
| >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.
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