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Last Updated: August 17, 2022

EMEND Drug Patent Profile


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When do Emend patents expire, and when can generic versions of Emend launch?

Emend is a drug marketed by Merck, Msd Merck Co, and Merck And Co Inc. and is included in three NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has forty-eight patent family members in thirty-seven countries.

The generic ingredient in EMEND is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.

Paragraph IV (Patent) Challenges for EMEND
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EMEND for Oral Suspension aprepitant 125 mg/Kit 207865 1 2016-11-23
EMEND Injection fosaprepitant dimeglumine 150 mg/vial 022023 2 2012-01-25
EMEND Capsule aprepitant 40 mg, 80 mg and 125 mg 021549 1 2008-11-03

US Patents and Regulatory Information for EMEND

EMEND is protected by three US patents and one FDA Regulatory Exclusivity.

Patents protecting EMEND

Pharmaceutical composition of a tachykinin receptor antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH CHEMOTHERAPY

Pharmaceutical composition of a tachykinin receptor antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING

Pharmaceutical composition of a tachykinin receptor antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH CHEMOTHERAPY (CINV)

FDA Regulatory Exclusivity protecting EMEND

ADDITION OF A 3-DAY FOSAPREPITANT FOR INJECTION INTRAVENOUS DOSING REGIMEN IN PEDIATRIC PATIENTS FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING.
Exclusivity Expiration: 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
Merck EMEND aprepitant CAPSULE;ORAL 021549-003 Jun 30, 2006 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Merck Co EMEND aprepitant FOR SUSPENSION;ORAL 207865-001 Dec 17, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-001 Jan 25, 2008 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck EMEND aprepitant CAPSULE;ORAL 021549-001 Mar 26, 2003 AB RX Yes No 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 EMEND

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-002 Nov 12, 2010 See Plans and Pricing See Plans and Pricing
Merck EMEND aprepitant CAPSULE;ORAL 021549-003 Jun 30, 2006 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 And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-001 Jan 25, 2008 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 EMEND

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 EMEND

See the table below for patents covering EMEND around the world.

Country Patent Number Title Estimated Expiration
Slovenia 1455756 See Plans and Pricing
Argentina 037713 COMPOSICION FARMACEUTICA DE UN ANTAGONISTA DE RECEPTORES DE TAQUICININA See Plans and Pricing
Latvia 11617 MORPHOLINE AND THIOMORPHOLINE TACHYKININ RECEPTOR ANTAGONISTS See Plans and Pricing
Japan H09509935 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EMEND

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 SPC005/2004 Ireland See Plans and Pricing SPC005/2004: 20050504, EXPIRES: 20181110
0734381 91069 Luxembourg See Plans and Pricing 91069, EXPIRES: 20181111
0734381 PA2004002 Lithuania See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Medtronic
Merck
McKesson
Dow

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