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 |
---|---|
Eli Lilly and Company | Phase 2 |
Jose Pablo Leone | Phase 2 |
Translational Breast Cancer Research Consortium (TBCRC) | 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 |
---|---|---|---|
Brazil | 6352734 | ⤷ Try a Trial | |
Switzerland | 500165 | Verfahren zur Herstellung eines Alkenderivats (Cis and trans 1-p-b-methyl-or ethyl- -amino-ethoxyphenyl-1 2-diphenyl - prop or but -1-ene) | ⤷ Try a Trial |
Belgium | 678807 | ⤷ Try a Trial | |
Switzerland | 538447 | Verfahren zur Herstellung der cis- oder trans-Isomeren von Alkenderivaten | ⤷ Try a Trial |
Germany | 1568834 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |