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Generated: December 13, 2017

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RALOXIFENE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for raloxifene hydrochloride and what is the scope of raloxifene hydrochloride patent protection?

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

Raloxifene hydrochloride has forty-five patent family members in thirty-three countries and two supplementary protection certificates in two countries.

There are sixteen drug master file entries for raloxifene hydrochloride. Twenty-two suppliers are listed for this compound.

Pharmacology for RALOXIFENE HYDROCHLORIDE

Medical Subject Heading (MeSH) Categories for RALOXIFENE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms LtdRALOXIFENE HYDROCHLORIDEraloxifene hydrochlorideTABLET;ORAL204491-001Mar 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Amneal PharmsRALOXIFENE HYDROCHLORIDEraloxifene hydrochlorideTABLET;ORAL208206-001Apr 8, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdRALOXIFENE HYDROCHLORIDEraloxifene hydrochlorideTABLET;ORAL204310-001Aug 28, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sciegen Pharms IncRALOXIFENE HYDROCHLORIDEraloxifene hydrochlorideTABLET;ORAL206384-001Oct 12, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaRALOXIFENE HYDROCHLORIDEraloxifene hydrochlorideTABLET;ORAL078193-001Mar 4, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997ABRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Invagen PharmsRALOXIFENE HYDROCHLORIDEraloxifene hydrochlorideTABLET;ORAL090842-001Sep 24, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: raloxifene hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
LillyEVISTAraloxifene hydrochlorideTABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
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International Patent Family for Ingredient: raloxifene hydrochloride

Country Document Number Estimated Expiration
European Patent Office2266560► Subscribe
New Zealand333913► Subscribe
Slovenia0910369► Subscribe
Portugal910369► Subscribe
Israel140742► Subscribe
Japan2015157865► Subscribe
New Zealand332036► Subscribe
Brazil9708248► Subscribe
Norway320894► Subscribe
Czech Republic9803053► 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
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
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
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Serving leading biopharmaceutical companies globally:

US Army
Chubb
Deloitte
Mallinckrodt
Teva
Johnson and Johnson
Fish and Richardson
QuintilesIMS
AstraZeneca
Federal Trade Commission

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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