EMEND Drug Patent Profile

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-three suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Emend

A generic version of EMEND was approved as fosaprepitant dimeglumine by FRESENIUS KABI USA on June 9^th, 2016.

Summary for EMEND

International Patents:	48
US Patents:	1
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Patent Applications:	2,252
Drug Prices:	Drug price information for EMEND
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMEND
What excipients (inactive ingredients) are in EMEND?	EMEND excipients list
DailyMed Link:	EMEND at DailyMed

See drug prices for EMEND

Pharmacology for EMEND

Drug Class	Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

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

FDA Regulatory Exclusivity protecting EMEND

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			Y
Msd Merck Co	EMEND	aprepitant	FOR SUSPENSION;ORAL	207865-001	Dec 17, 2015		RX	Yes	Yes			Y
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008		DISCN	Yes	No
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003	AB	RX	Yes	No			Y
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-002	Mar 26, 2003	AB	RX	Yes	Yes			Y
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	AP	RX	Yes	Yes

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
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010
Msd Merck Co	EMEND	aprepitant	FOR SUSPENSION;ORAL	207865-001	Dec 17, 2015

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

International Patents for EMEND

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	62963
Bulgaria	100798
Russian Federation	2201924	МОРФОЛИНОВОЕ ПРОИЗВОДНОЕ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ЕГО ОСНОВЕ (MORPHOLINE DERIVATIVE AND PHARMACEUTICAL COMPOSITION BASED ON THEREOF)
Algeria	1700	Morpholine et thiomorpholine comme antagonistes des récepteurs de tachydinine.
Norway	962523
Germany	122008000037

Supplementary Protection Certificates for EMEND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0748320	SPC/GB08/021	United Kingdom		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
0748320	08C0019	France		PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
0734381	SPC005/2004	Ireland		SPC005/2004: 20050504, EXPIRES: 20181110
0734381	3/2004	Austria		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	300146	Netherlands		300146, 20141213, EXPIRES: 20181110
0734381	PA2004002	Lithuania		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