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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 four 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. Four 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
Bulk Api Vendors: see list64
Clinical Trials: see list13
Patent Applications: see list1,524
Drug Prices:see details
DailyMed Link:EMEND at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Merck Co
EMEND
aprepitant
FOR SUSPENSION;ORAL207865-001Dec 17, 2015RXYesYes► subscribe► subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003RXYesYes► subscribe► subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-001Jan 25, 2008DISCNYesNo5,691,336► subscribeYY ► subscribe
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Expired Patents for Tradename: EMEND

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 20036,048,859► subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 20065,145,684► subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-001Mar 26, 20035,145,684► subscribe
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Paragraph IV activity for: EMEND

Drugname Dosage Strength RLD Submissiondate
aprepitantfor Oral Suspension125 mg/KitEmend11/23/2016
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
5,512,570 Treatment of emesis with morpholine tachykinin receptor antagonists► subscribe
6,229,010 Polymorphic form of a tachykinin receptor antagonist► subscribe
6,432,953 Polymorphic form of a tachykinin receptor antagonist► 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 Tradename: EMEND

Country Document Number Estimated Expiration
Indonesia23191► subscribe
Colombia5590887► subscribe
Colombia4340689► 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: EMEND

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
2004002,C0734381Lithuania► subscribePRODUCT 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, 2003 11 11, EU/1/03/262/002, 2003 11 11, EU/1/03/262/003, 2003 11 11, EU/1/03/262/004, 2003 11 11, EU/1/03/262/005, 2003 11 11, EU/1/03/262/006 20031111
2004Austria► subscribePRODUCT NAME: APREPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/03/262/001 - EU/1/03/262/006 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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