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Last Updated: August 8, 2020

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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, Merck, Heron Theraps Inc, and Msd Merck Co, and is included in five NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twenty-six drug master file entries for aprepitant. Four 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
Heron TherapeuticsPhase 2
bahria international hospitalPhase 3
University of LahorePhase 3

See all aprepitant clinical trials

Paragraph IV (Patent) Challenges for APREPITANT
Tradename Dosage Ingredient NDA Submissiondate
EMEND FOR SUSPENSION;ORAL aprepitant 207865 2016-11-23
EMEND CAPSULE;ORAL aprepitant 021549 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   Start Trial   Start Trial Y   Start Trial
Sandoz APREPITANT aprepitant CAPSULE;ORAL 090999-003 Sep 24, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms Sa APREPITANT aprepitant CAPSULE;ORAL 207777-001 Oct 12, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Merck EMEND aprepitant CAPSULE;ORAL 021549-002 Mar 26, 2003 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sandoz APREPITANT aprepitant CAPSULE;ORAL 090999-001 Sep 24, 2012 AB RX No No   Start Trial   Start Trial   Start 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 021549-002 Mar 26, 2003   Start Trial   Start Trial
Merck EMEND aprepitant CAPSULE;ORAL 021549-003 Jun 30, 2006   Start Trial   Start Trial
Merck EMEND aprepitant CAPSULE;ORAL 021549-003 Jun 30, 2006   Start Trial   Start Trial
Merck EMEND aprepitant CAPSULE;ORAL 021549-001 Mar 26, 2003   Start Trial   Start Trial
Merck EMEND aprepitant CAPSULE;ORAL 021549-002 Mar 26, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for aprepitant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0748320 SPC/GB08/021 United Kingdom   Start 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 PA2004002 Lithuania   Start 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
0734381 3/2004 Austria   Start 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 PA2004002,C0734381 Lithuania   Start Trial PRODUCT 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
0748320 08C0019 France   Start Trial PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
AstraZeneca
Medtronic
Moodys
McKinsey

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