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Aprepitant - Generic Drug Details

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Aprepitant is the generic ingredient in two branded drugs marketed by Merck, Msd Merck Co, and Sandoz, and is included in three NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are nineteen drug master file entries for aprepitant. Three suppliers are listed for this compound.

Summary for Generic Name: aprepitant

Tradenames:2
Patents:2
Applicants:3
NDAs:3
Drug Master File Entries: see list19
Suppliers / Packaging: see list3
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Clinical Trials for: aprepitant

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003RXYes6,096,742Jul 1, 2018YY
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003RXYesAug 28, 2018
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003RXYes6,096,742Jul 1, 2018
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Expired Orange Book Patents for Generic Ingredient: aprepitant

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 20035,145,684<disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 20037,214,692<disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 20036,048,859<disabled>
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Non-Orange Book Patents for Generic Ingredient: aprepitant

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
6,583,142 Polymorphic form of a tachykinin receptor antagonist<disabled in preview>
6,229,010 Polymorphic form of a tachykinin receptor antagonist<disabled in preview>
6,432,953 Polymorphic form of a tachykinin receptor antagonist<disabled in preview>
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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: aprepitant

Country Document Number Estimated Expiration
Australia8283398<disabled in preview>
Czech Republic9904777<disabled in preview>
Iceland2617<disabled in preview>
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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: APREPITANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0019France<disabled>PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
2004Austria<disabled>PRODUCT NAME: APREPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/03/262/001 - EU/1/03/262/006 20031111
C0010France<disabled>PRODUCT NAME: APREPITANT; REGISTRATION NO/DATE: EU/1/03/262/001 20031111
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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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