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Raloxifene hydrochloride - Generic Drug Details

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Raloxifene hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharms, Aurobindo Pharma Ltd, Lilly, Watson Labs Inc, Invagen Pharms, Sciegen Pharms Inc, Glenmark Pharms Ltd, and Teva Pharms Usa, and is included in eight NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-three patent family members in thirty-three countries.

There are fifteen drug master file entries for raloxifene hydrochloride. Twenty suppliers are listed for this compound.

Summary for Generic Name: raloxifene hydrochloride

Tradenames:2
Patents:4
Applicants:8
NDAs:8
Drug Master File Entries: see list15
Suppliers / Packaging: see list20
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: raloxifene hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997RXYes6,797,719► subscribeY ► subscribe
Amneal Pharms
RALOXIFENE HYDROCHLORIDE
raloxifene hydrochloride
TABLET;ORAL208206-001Apr 8, 2016RXNo► subscribe► subscribe
Invagen Pharms
RALOXIFENE HYDROCHLORIDE
raloxifene hydrochloride
TABLET;ORAL090842-001Sep 24, 2014RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: raloxifene hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 19975,747,510► subscribe
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997RE39049► subscribe
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 19975,808,061► subscribe
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International Patent Family for Ingredient: raloxifene hydrochloride

Country Document Number Estimated Expiration
Hong Kong1020671► subscribe
Portugal910369► subscribe
European Patent Office2266560► 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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Supplementary Protection Certificates for Tradename: RALOXIFENE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0044Netherlands► subscribePRODUCT NAME: RALOXIFENE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/98/073/001 - EU/1/98/073/004, EU/1/98/074/001 - EU/1/98/074/004 19980805 EU/1/98/073/001
C/GB98/048United Kingdom► subscribePRODUCT NAME: RALOXIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/98/073/001 19980805; UK EU/1/98/073/002 19980805; UK EU/1/98/073/003 19980805; UK EU/1/98/073/004 19980805; UK EU/1/98/074/001 19980805; UK EU/1/98/074/002 19980805; UK EU/1/98/074/003 19980805; UK EU/1/98/074/004 19980805
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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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