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Last Updated: August 5, 2020

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Tamoxifen citrate - Generic Drug Details

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What are the generic sources for tamoxifen citrate and what is the scope of freedom to operate?

Tamoxifen citrate is the generic ingredient in three branded drugs marketed by Fortovia, Astrazeneca, Actavis Labs Fl Inc, Aegis Pharms, Apotex, Ivax Sub Teva Pharms, Mayne Pharma, Mylan, Pharmachemie, Roxane, Teva, and Zydus Pharms, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for tamoxifen citrate. Eleven suppliers are listed for this compound.

Drug Prices for tamoxifen citrate

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Drug Sales Revenue Trends for tamoxifen citrate

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Recent Clinical Trials for tamoxifen citrate

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SponsorPhase
TYK Medicines, IncPhase 1
British Columbia Cancer AgencyPhase 2
Canadian Cancer Society Research Institute (CCSRI)Phase 2

See all tamoxifen citrate clinical trials

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

US Patents and Regulatory Information for tamoxifen citrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 074732-001 Feb 20, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Roxane TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 076027-001 Feb 20, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Zydus Pharms TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 206694-001 Oct 27, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Astrazeneca NOLVADEX tamoxifen citrate TABLET;ORAL 017970-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start 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 tamoxifen citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fortovia SOLTAMOX tamoxifen citrate SOLUTION;ORAL 021807-001 Oct 29, 2005   Start Trial   Start Trial
Astrazeneca NOLVADEX tamoxifen citrate TABLET;ORAL 017970-002 Mar 21, 1994   Start Trial   Start Trial
Astrazeneca NOLVADEX tamoxifen citrate TABLET;ORAL 017970-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
McKesson
Boehringer Ingelheim
Baxter
Merck

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