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Serving leading biopharmaceutical companies globally:

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Generated: November 19, 2017

DrugPatentWatch Database Preview

Fosaprepitant dimeglumine - Generic Drug Details

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What are the generic sources for fosaprepitant dimeglumine and what is the scope of fosaprepitant dimeglumine patent protection?

Fosaprepitant dimeglumine
is the generic ingredient in two branded drugs marketed by Merck And Co Inc and Fresenius Kabi Usa, and is included in two NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fosaprepitant dimeglumine has thirty-six patent family members in twenty-seven countries and two supplementary protection certificates in two countries.

There are nine drug master file entries for fosaprepitant dimeglumine. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for fosaprepitant dimeglumine

Tentative approvals for FOSAPREPITANT DIMEGLUMINE

Applicant Application No. Strength Dosage Form
u► Subscribe150MGINJECTABLE;INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
FOSAPREPITANT DIMEGLUMINE
fosaprepitant dimeglumine
POWDER;INTRAVENOUS206197-001Jun 9, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 2010APRXYesYes► Subscribe► SubscribeYY ► Subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 2010APRXYesYes► Subscribe► Subscribe► Subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-001Jan 25, 2008DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fosaprepitant dimeglumine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 2010► Subscribe► Subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-001Jan 25, 2008► Subscribe► Subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-001Jan 25, 2008► Subscribe► Subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 2010► Subscribe► Subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-001Jan 25, 2008► Subscribe► Subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 2010► Subscribe► Subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-001Jan 25, 2008► Subscribe► Subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 2010► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: fosaprepitant dimeglumine

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
5,512,570 Treatment of emesis with morpholine tachykinin receptor antagonists► Subscribe
5,780,467 Morpholine compounds are prodrugs useful as tachykinin receptor antagonists► Subscribe
5,716,942 Treatment of migraine with morpholine tachykinin receptor antagonists► 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: fosaprepitant dimeglumine

Country Document Number Estimated Expiration
Brazil9507046► Subscribe
Canada2183250► Subscribe
Germany122008000037► Subscribe
South Africa9501780► Subscribe
China1147254► Subscribe
Australia1975095► Subscribe
Japan3073770► Subscribe
Latvia11688► Subscribe
Poland180522► Subscribe
China1075812► 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: FOSAPREPITANT DIMEGLUMINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/021United Kingdom► SubscribePRODUCT NAME: FOSAPREPITANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE BIS(N-METHYL-D-GLUCAMINE)SALT; REGISTERED: UK EU/1/07/437/001 20080111; UK EU/1/07/437/002 20080111
C0019France► SubscribePRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
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Serving leading biopharmaceutical companies globally:

Queensland Health
Citi
Healthtrust
Julphar
Novartis
Merck
Deloitte
Daiichi Sankyo
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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