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Ospemifene - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ospemifene?

Ospemifene is the generic ingredient in one branded drug marketed by Shionogi Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ospemifene has seventy-eight patent family members in thirty countries.

There are five drug master file entries for ospemifene. One supplier is listed for this compound.

Summary for Generic Name: ospemifene

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packagers: see list1
Bulk Api Vendors: see list27
Clinical Trials: see list2
Patent Applications: see list58
Drug Prices:see low prices
DailyMed Link:ospemifene at DailyMed

Pharmacology for Ingredient: ospemifene

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shionogi Inc
OSPHENA
ospemifene
TABLET;ORAL203505-001Feb 26, 2013RXYesYes8,236,861► Subscribe ► Subscribe
Shionogi Inc
OSPHENA
ospemifene
TABLET;ORAL203505-001Feb 26, 2013RXYesYes8,772,353► Subscribe ► Subscribe
Shionogi Inc
OSPHENA
ospemifene
TABLET;ORAL203505-001Feb 26, 2013RXYesYes9,241,915► Subscribe ► Subscribe
Shionogi Inc
OSPHENA
ospemifene
TABLET;ORAL203505-001Feb 26, 2013RXYesYes8,470,890► Subscribe ► Subscribe
Shionogi Inc
OSPHENA
ospemifene
TABLET;ORAL203505-001Feb 26, 2013RXYesYes8,642,079► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ospemifene

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,984,665Methods for the inhibition of atrophy or for treatment or prevention of atrophy-related symptoms in women► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ospemifene

Country Document Number Estimated Expiration
Japan5575351► Subscribe
Israel153823► Subscribe
World Intellectual Property Organization (WIPO)2005077350► Subscribe
BrazilPI0507661► Subscribe
China1953741► 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: OSPEMIFENE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00031Denmark► SubscribePRODUCT NAME: OSPEMIFENE OR A GEOMETRIC ISOMER THEREOF, A STEREOISOMER THEREOF, A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AN ESTER THEREOF OR A METABOLITE THEREOF; REG. NO/DATE: EU/1/14/978/001-002 20150115
736Luxembourg► SubscribePRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION: 20150115
00742Netherlands► SubscribePRODUCT NAME: OSPEMIFEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/978 20150115
C0041France► SubscribePRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/978 20150115
6 5010-2015Slovakia► SubscribePRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978 20150119
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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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