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Last Updated: October 6, 2022

Aprepitant - Generic Drug Details


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What are the generic sources for aprepitant and what is the scope of patent protection?

Aprepitant is the generic ingredient in three branded drugs marketed by Glenmark Pharms Sa, Sandoz, Torrent, Merck, Heron Theraps Inc, and Msd Merck Co, and is included in six NDAs. There are ten patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Aprepitant has fifty-seven patent family members in thirty-seven countries.

There are twenty-six drug master file entries for aprepitant. Five suppliers are listed for this compound.

Summary for aprepitant
Drug Prices for aprepitant

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Recent Clinical Trials for aprepitant

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SponsorPhase
Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyPhase 3
University Hospital Inselspital, BernePhase 4
Jennifer Holder-MurrayPhase 3

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Paragraph IV (Patent) Challenges for APREPITANT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CINVANTI Intravenous Emulsion aprepitant 130 mg/18 mL 209296 1 2022-04-29
EMEND for Oral Suspension aprepitant 125 mg/Kit 207865 1 2016-11-23
EMEND Capsule aprepitant 40 mg, 80 mg and 125 mg 021549 1 2008-11-03

US Patents and Regulatory Information for aprepitant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Heron Theraps Inc CINVANTI aprepitant EMULSION;INTRAVENOUS 209296-001 Nov 9, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Heron Theraps Inc CINVANTI aprepitant EMULSION;INTRAVENOUS 209296-001 Nov 9, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Heron Theraps Inc CINVANTI aprepitant EMULSION;INTRAVENOUS 209296-001 Nov 9, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for aprepitant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck EMEND aprepitant CAPSULE;ORAL 021549-002 Mar 26, 2003 See Plans and Pricing See Plans and Pricing
Merck EMEND aprepitant CAPSULE;ORAL 021549-002 Mar 26, 2003 See Plans and Pricing See Plans and Pricing
Merck EMEND aprepitant CAPSULE;ORAL 021549-001 Mar 26, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for aprepitant

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp & Dohme B.V. Emend aprepitant EMEA/H/C/000527
Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults., , Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics)., , Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults., , Emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years., , Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy.,
Authorised no no no 2003-11-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for aprepitant

Country Patent Number Title Estimated Expiration
Japan 2005516003 See Plans and Pricing
Eurasian Patent Organization 007332 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ АНТАГОНИСТА РЕЦЕПТОРА ТАХИКИНИНА В ФОРМЕ НАНОЧАСТИЦ (PHARMACEUTICAL NANOPARTICULATE COMPOSITION OF A TACHYKININ RECEPTOR ANTAGONISTS) See Plans and Pricing
Argentina 037713 COMPOSICION FARMACEUTICA DE UN ANTAGONISTA DE RECEPTORES DE TAQUICININA See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aprepitant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0748320 08C0019 France See Plans and Pricing PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
0734381 SPC/GB04/011 United Kingdom See Plans and Pricing 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
0748320 SPC/GB08/021 United Kingdom See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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