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EMEND Drug Profile

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Emend is a drug marketed by Merck And Co Inc, Merck, and Msd Merck Co. and is included in three NDAs. It is available from three suppliers. There are three patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and eighteen patent family members in forty-seven countries.

The generic ingredient in EMEND is aprepitant. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aprepitant profile page.

Summary for Tradename: EMEND

Patents:3
Applicants:3
NDAs:3
Suppliers / Packagers: see list3

Clinical Trials for: EMEND

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, 2003RXYes<disabled><disabled>
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-001Jan 25, 2008DISCNNo5,691,336<disabled>YY <disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003RXYes6,096,742<disabled> <disabled>
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Expired Patents for Tradename: EMEND

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 20035,538,982<disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 20065,719,147<disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 20066,235,735<disabled>
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Paragraph IV activity for: EMEND

Drugname Dosage Strength RLD Submissiondate
fosaprepitant dimeglumineInjection150 mg/vialEmend1/25/2012
fosaprepitant dimeglumineInjection115 mg/vialEmend1/25/2012
aprepitantCapsule40 mg, 80 mg and 125 mgEmend11/3/2008

Non-Orange Book Patents for Tradename: EMEND

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
6,229,010 Polymorphic form of a tachykinin receptor antagonist<disabled in preview>
5,512,570 Treatment of emesis with morpholine tachykinin receptor antagonists<disabled in preview>
5,780,467 Morpholine compounds are prodrugs useful as tachykinin receptor antagonists<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 Tradename: EMEND

Country Document Number Estimated Expiration
Indonesia23191<disabled in preview>
Norway316893<disabled in preview>
Iceland5293<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: EMEND

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0019France<disabled>PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
C/GB04/011United Kingdom<disabled>PRODUCT NAME: APREPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/03/262/001 20031113; UK EU/1/03/262/002 20031113; UK EU/1/03/262/003 20031113; UK EU/1/03/262/004 20031113; UK EU/1/03/262/005 20031113; UK EU/1/03/262/006 20031113
C0010France<disabled>PRODUCT NAME: APREPITANT; REGISTRATION NO/DATE: EU/1/03/262/001 20031111
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