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Tamoxifen citrate - Generic Drug Details

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

This ingredient has six patent family members in seven countries.

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

Summary for Generic Name: tamoxifen citrate

Tradenames:3
Patents:1
Applicants:11
NDAs:13
Drug Master File Entries: see list16
Suppliers / Packaging: see list11
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: tamoxifen citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma
TAMOXIFEN CITRATE
tamoxifen citrate
TABLET;ORAL075797-001Feb 20, 2003RXNo► subscribe► subscribe
Ivax Sub Teva Pharms
TAMOXIFEN CITRATE
tamoxifen citrate
TABLET;ORAL075740-002Feb 20, 2003DISCNNo► subscribe► subscribe
Mylan
TAMOXIFEN CITRATE
tamoxifen citrate
TABLET;ORAL074732-001Feb 20, 2003RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: tamoxifen citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
NOLVADEX
tamoxifen citrate
TABLET;ORAL017970-002Mar 21, 19944,536,516*PED► subscribe
Astrazeneca
NOLVADEX
tamoxifen citrate
TABLET;ORAL017970-001Approved Prior to Jan 1, 19824,536,516*PED► subscribe
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International Patent Family for Ingredient: tamoxifen citrate

Country Document Number Estimated Expiration
Portugal893121► subscribe
JapanH1171269► subscribe
Denmark0893121► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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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