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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

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;ORAL021549-001Mar 26, 2003RXNo6,096,742<disabled> <disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 2006RXNo<disabled><disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003RXYes8,258,132<disabled>Y <disabled>
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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;ORAL021549-001Mar 26, 20035,145,684<disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 20065,538,982<disabled>
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 20067,214,692<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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International Patent Family for Ingredient: aprepitant

Country Document Number Estimated Expiration
Denmark1455756<disabled in preview>
China1617712<disabled in preview>
Poland191496<disabled in preview>
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Supplementary Protection Certificates for Tradename: APREPITANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C/GB08/021United Kingdom<disabled>PRODUCT 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
2004002Lithuania<disabled>PRODCUT NAME: 5-[[(2R,3S)-2-[(1R)-1-[3,5-BIS(TRIFLUORMETIL)FENIL]ETOKSI]-3-(4-FLUORFENIL)-4-MORFOLINIL]METIL]-1,2-DIHIDRO-3H-1,2,4-TRIAZOL-3-ONAS (APREPITANTAS); REGISTRATION NO./DATE: EU/1/03/262/001-006/20031111
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