APREPITANT - Generic Drug Details

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What are the generic sources for aprepitant and what is the scope of freedom to operate?

Aprepitant is the generic ingredient in four branded drugs marketed by Glenmark Speclt, 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. There is one tentative approval for this compound.

Summary for APREPITANT

International Patents:	57
US Patents:	12
Tradenames:	4
Applicants:	6
NDAs:	7
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	175
Patent Applications:	4,952
Drug Prices:	Drug price trends for APREPITANT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APREPITANT
What excipients (inactive ingredients) are in APREPITANT?	APREPITANT excipients list
DailyMed Link:	APREPITANT at DailyMed

See drug prices for APREPITANT

Recent Clinical Trials for APREPITANT

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

Sponsor	Phase
Hubei Cancer Hospital	N/A
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Guangxi Medical University	Phase 3

See all APREPITANT clinical trials

Generic filers with tentative approvals for APREPITANT

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	130MG/18ML (7.2MG/ML)	INJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for APREPITANT

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

Anatomical Therapeutic Chemical (ATC) Classes for APREPITANT

A04AD	Other antiemetics
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Torrent	APREPITANT	aprepitant	CAPSULE;ORAL	211835-003	Oct 21, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	APREPITANT	aprepitant	CAPSULE;ORAL	090999-003	Sep 24, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent	APREPITANT	aprepitant	CAPSULE;ORAL	211835-002	Oct 21, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Speclt	APREPITANT	aprepitant	CAPSULE;ORAL	207777-002	Oct 12, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003	⤷ Sign Up	⤷ Sign Up
Msd Merck Co	EMEND	aprepitant	FOR SUSPENSION;ORAL	207865-001	Dec 17, 2015	⤷ Sign Up	⤷ Sign Up
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006	⤷ Sign Up	⤷ Sign Up
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003	⤷ Sign Up	⤷ Sign Up
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-002	Mar 26, 2003	⤷ Sign Up	⤷ Sign Up
Merck	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for APREPITANT

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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

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Country	Patent Number	Title	Estimated Expiration
South Korea	20170056575	아프레피탄트의 에멀젼 제형 (EMULSION FORMULATIONS OF APREPITANT)	⤷ Sign Up
Slovenia	1455756		⤷ Sign Up
European Patent Office	1455756	COMPOSITION PHARMACEUTIQUE NANOPARTICULAIRE A BASE D'UN ANTAGONISTE DU RECEPTEUR DE LA TACHYKININE (PHARMACEUTICAL NANOPARTICULATE COMPOSITION OF A TACHYKININ RECEPTOR ANTAGONIST)	⤷ Sign Up
Ecuador	SP045144	COMPOSICIÓN FARMACÉUTICA DE UN ANTAGONISTA DE RECEPTORES DE TAQUICININA	⤷ Sign Up
Hungary	230736	Pharmaceutical nanoparticulate composition of a tachykinin receptor antagonist	⤷ Sign Up
South Korea	102424837		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for APREPITANT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0748320	SPC/GB08/021	United Kingdom	⤷ Sign Up	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	SPC/GB04/011	United Kingdom	⤷ Sign Up	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
0734381	PA2004002,C0734381	Lithuania	⤷ Sign Up	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
0734381	3/2004	Austria	⤷ Sign Up	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	⤷ Sign Up	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	04C0010	France	⤷ Sign Up	PRODUCT NAME: APREPITANT; REGISTRATION NO/DATE: EU/1/03/262/001 20031111
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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