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Serving leading biopharmaceutical companies globally:

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Chinese Patent Office
Johnson and Johnson
Teva
Covington
McKinsey
Healthtrust
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Generated: October 20, 2017

DrugPatentWatch Database Preview

Aprepitant - Generic Drug Details

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What are the generic drug sources for aprepitant and what is the scope of aprepitant freedom to operate?

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 four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Aprepitant has eighty-eight patent family members in forty-four countries and seven supplementary protection certificates in four countries.

There are twenty-two drug master file entries for aprepitant. Four suppliers are listed for this compound.

Summary for Generic Name: aprepitant

US Patents:2
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: see list22
Suppliers / Packagers: see list4
Bulk Api Vendors: see list44
Clinical Trials: see list132
Patent Applications: see list78
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:aprepitant at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-001Mar 26, 2003ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-001Mar 26, 2003ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 2006ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-001Mar 26, 2003ABRXYesNo► Subscribe► Subscribe ► Subscribe
Sandoz
APREPITANT
aprepitant
CAPSULE;ORAL090999-002Sep 24, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Msd Merck Co
EMEND
aprepitant
FOR SUSPENSION;ORAL207865-001Dec 17, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 2006ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Sandoz
APREPITANT
aprepitant
CAPSULE;ORAL090999-003Sep 24, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
APREPITANT
aprepitant
CAPSULE;ORAL090999-001Sep 24, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: aprepitant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 2006► Subscribe► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 2006► Subscribe► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-001Mar 26, 2003► Subscribe► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003► Subscribe► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-001Mar 26, 2003► Subscribe► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003► Subscribe► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-001Mar 26, 2003► Subscribe► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-001Mar 26, 2003► Subscribe► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 2006► Subscribe► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003► Subscribe► Subscribe
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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
6,229,010 Polymorphic form of a tachykinin receptor antagonist► Subscribe
6,583,142 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 Ingredient: aprepitant

Country Document Number Estimated Expiration
Japan2000513383► Subscribe
South Africa200404012► Subscribe
World Intellectual Property Organization (WIPO)9901444► Subscribe
Argentina037713► Subscribe
Serbia52280► Subscribe
Canada2469315► Subscribe
China1261882► Subscribe
Peru06412003► Subscribe
Hong Kong1078017► Subscribe
Norway996549► 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: APREPITANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0010France► SubscribePRODUCT NAME: APREPITANT; REGISTRATION NO/DATE: EU/1/03/262/001 20031111
2004002Lithuania► SubscribePRODCUT 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
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
C0019France► SubscribePRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 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
C/GB04/011United Kingdom► SubscribePRODUCT 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
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Colorcon
US Army
Express Scripts
Baxter
Argus Health
Chinese Patent Office
Cipla
Merck
Cantor Fitzgerald
Citi

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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