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Last Updated: March 29, 2024

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 four branded drugs marketed by Glenmark Pharms Sa, Sandoz, Torrent, Merck, Heron Theraps Inc, and Msd Merck Co, and is included in seven NDAs. There are twelve 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.

Drug Prices for aprepitant

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Recent Clinical Trials for aprepitant

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Guangxi Medical UniversityPhase 3
Hospital General TlahuacPhase 4

See all aprepitant clinical trials

Paragraph IV (Patent) Challenges for APREPITANT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
APONVIE Intravenous Emulsion aprepitant 32 mg/4.4 mL 216457 1 2023-11-07
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
Merck EMEND aprepitant CAPSULE;ORAL 021549-002 Mar 26, 2003 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Heron Theraps Inc CINVANTI aprepitant EMULSION;INTRAVENOUS 209296-001 Nov 9, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Heron Theraps Inc APONVIE aprepitant EMULSION;INTRAVENOUS 216457-001 Sep 16, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heron Theraps Inc CINVANTI aprepitant EMULSION;INTRAVENOUS 209296-001 Nov 9, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 021549-001 Mar 26, 2003 ⤷  Try a Trial ⤷  Try a Trial
Merck EMEND aprepitant CAPSULE;ORAL 021549-002 Mar 26, 2003 ⤷  Try a Trial ⤷  Try a Trial
Merck EMEND aprepitant CAPSULE;ORAL 021549-003 Jun 30, 2006 ⤷  Try a Trial ⤷  Try a Trial
Msd Merck Co EMEND aprepitant FOR SUSPENSION;ORAL 207865-001 Dec 17, 2015 ⤷  Try a Trial ⤷  Try a Trial
>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
China 100352443 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2016044784 ⤷  Try a Trial
Croatia P20040532 FARMACEUTSKI NANOPARTIKULARNI PRIPRAVAK ANTAGONISTA RECEPTORA TAHIKININA (PHARMACEUTICAL NANOPARTICULATE COMPOSITION OF A TACHYKININ RECEPTOR NATAGONIST) ⤷  Try a Trial
Eurasian Patent Organization 007332 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ АНТАГОНИСТА РЕЦЕПТОРА ТАХИКИНИНА В ФОРМЕ НАНОЧАСТИЦ (PHARMACEUTICAL NANOPARTICULATE COMPOSITION OF A TACHYKININ RECEPTOR ANTAGONISTS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aprepitant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0734381 PA2004002 Lithuania ⤷  Try a Trial 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
0748320 SPC/GB08/021 United Kingdom ⤷  Try a Trial 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
0734381 3/2004 Austria ⤷  Try a Trial PRODUCT NAME: APREPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/03/262/001 - EU/1/03/262/006 20031111
0734381 SPC/GB04/011 United Kingdom ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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