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Last Updated: May 11, 2021

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NOLVADEX Drug 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. Twelve 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.

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Summary for NOLVADEX
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 43
Formulation / Manufacturing:see details
DailyMed Link:NOLVADEX at DailyMed
Drug patent expirations by year for NOLVADEX
Recent Clinical Trials for NOLVADEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
QED Therapeutics, Inc.Phase 1
Breast Cancer Research FoundationPhase 1
Stanford UniversityPhase 1

See all NOLVADEX clinical trials

Paragraph IV (Patent) Challenges for NOLVADEX
Tradename Dosage Ingredient NDA Submissiondate
NOLVADEX TABLET;ORAL tamoxifen citrate 017970

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   Get Started for $10   Get Started for $10   Get Started for $10
Astrazeneca NOLVADEX tamoxifen citrate TABLET;ORAL 017970-002 Mar 21, 1994 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
>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   Get Started for $10   Get Started for $10
Astrazeneca NOLVADEX tamoxifen citrate TABLET;ORAL 017970-002 Mar 21, 1994   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Merck
Moodys
Dow
Mallinckrodt

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