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Generated: July 26, 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 freedom to operate?

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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Raloxifene hydrochloride has forty-three patent family members in thirty-three countries.

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

Summary for Generic Name: raloxifene hydrochloride

Tradenames:2
Patents:5
Applicants:8
NDAs:8
Drug Master File Entries: see list15
Suppliers / Packagers: see list21
Bulk Api Vendors: see list68
Clinical Trials: see list2,309
Patent Applications: see list3,665
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:raloxifene hydrochloride at DailyMed

Pharmacology for Ingredient: raloxifene hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs Inc
RALOXIFENE HYDROCHLORIDE
raloxifene hydrochloride
TABLET;ORAL200825-001Jan 21, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Aurobindo Pharma Ltd
RALOXIFENE HYDROCHLORIDE
raloxifene hydrochloride
TABLET;ORAL204310-001Aug 28, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Invagen Pharms
RALOXIFENE HYDROCHLORIDE
raloxifene hydrochloride
TABLET;ORAL090842-001Sep 24, 2014ABRXNoNo► Subscribe► Subscribe► 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
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
Lilly
EVISTA
raloxifene hydrochloride
TABLET;ORAL020815-001Dec 9, 1997► Subscribe► Subscribe
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International Patent Family for Ingredient: raloxifene hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9735571► Subscribe
Hungary9902750► Subscribe
Spain2341399► Subscribe
Brazil9708248► Subscribe
Poland329051► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
Johnson and Johnson
Mallinckrodt
Chubb
Boehringer Ingelheim
Queensland Health
McKesson
Express Scripts
Teva
Harvard Business School

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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