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Last Updated: October 6, 2022

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 Mayne Pharma Inc, Astrazeneca, Actavis Labs Fl Inc, Aegis Pharms, Apotex, Eugia Pharma, Ivax Sub Teva Pharms, Mayne Pharma, Mylan, Pharmachemie, Roxane, Teva, and Zydus Pharms, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for tamoxifen citrate. Thirteen 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
Sharif Medical Research CenterPhase 2
Baylor College of MedicineEarly Phase 1
Myotubular TrustPhase 1/Phase 2

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Pharmacology for tamoxifen citrate

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 074732-002 Feb 20, 2003 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mayne Pharma TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 075797-002 Feb 20, 2003 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 074732-001 Feb 20, 2003 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pharmachemie TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 074539-001 Mar 31, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aegis Pharms TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 076398-001 Mar 31, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Roxane TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 076027-001 Feb 20, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Mayne Pharma Inc SOLTAMOX tamoxifen citrate SOLUTION;ORAL 021807-001 Oct 29, 2005 See Plans and Pricing See Plans and Pricing
Astrazeneca NOLVADEX tamoxifen citrate TABLET;ORAL 017970-002 Mar 21, 1994 See Plans and Pricing See Plans and Pricing
Astrazeneca NOLVADEX tamoxifen citrate TABLET;ORAL 017970-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Merck

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