APONVIE Drug Patent Profile

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

Aponvie is a drug marketed by Heron Theraps Inc and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in five countries.

The generic ingredient in APONVIE is aprepitant. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aprepitant profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aponvie

A generic version of APONVIE was approved as aprepitant by SANDOZ on September 24^th, 2012.

Summary for APONVIE

International Patents:	9
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Patent Applications:	2,252
Drug Prices:	Drug price information for APONVIE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APONVIE
What excipients (inactive ingredients) are in APONVIE?	APONVIE excipients list
DailyMed Link:	APONVIE at DailyMed

See drug prices for APONVIE

Pharmacology for APONVIE

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 APONVIE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APONVIE	Intravenous Emulsion	aprepitant	32 mg/4.4 mL	216457	1	2023-11-07

US Patents and Regulatory Information for APONVIE

APONVIE is protected by eleven US patents.

Patents protecting APONVIE

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	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes			Y
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes			Y
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes			Y

EU/EMA Drug Approvals for APONVIE

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 APONVIE

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

Country	Patent Number	Title	Estimated Expiration
Japan	2022092040	アプレピタントのエマルジョン製剤
South Korea	102424837
Japan	2017533183	アプレピタントのエマルジョン製剤
South Korea	20170056575	아프레피탄트의 에멀젼 제형 (EMULSION FORMULATIONS OF APREPITANT)
Japan	6741655
European Patent Office	3193830	FORMULATIONS D'ÉMULSON D'APRÉPITANT (EMULSON FORMULATIONS OF APREPITANT)
Japan	2019196398	アプレピタントのエマルジョン製剤 (EMULSION FORMULATIONS OF APREPITANT)

Supplementary Protection Certificates for APONVIE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0734381	04C0010	France		PRODUCT NAME: APREPITANT; REGISTRATION NO/DATE: EU/1/03/262/001 20031111
0734381	PA2004002,C0734381	Lithuania		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		PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
0734381	SPC/GB04/011	United Kingdom		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		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		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	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