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APREPITANT

NDA

APREPITANT | N218754 | AZURITY PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Heron Therapeutics, Inc. v. Azurity Pharmaceuticals, Inc., et al. 1:2024cv01363 13 patentsaprepitant	D. Del.	2024-12-12	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

146 trials from ClinicalTrials.gov — 1 recruiting, 111 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy NCT07662200	Early Phase 1	Not Yet Recruiting	Ottawa Hospital Research Institute	10	2026-08 → 2028-08
A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208)NCT01362530	Phase 3	Completed	Merck Sharp & Dohme LLC	307	2011-09-13 → 2013-08-16
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy NCT03435003	Phase 4	Completed	Stony Brook University	83	2017-08-28 → 2019-04-01
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-068)(COMPLETED)NCT00035048	Phase 3	Completed	Merck Sharp & Dohme LLC	540	2001-11-21 → 2003-12-31
Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED)NCT00090207	Phase 4	Completed	Merck Sharp & Dohme LLC	477	2004-01-13 → 2004-09-30
A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)NCT00945321	Phase 1	Completed	Merck Sharp & Dohme LLC	42	2009-02 → 2009-03
Medications Development for the Treatment of Cannabis Related Disorders NCT01204723	Phase 1	Completed	University of Virginia	63	2009-08 → 2012-04
Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial NCT00475085	Phase 3	Completed	Joseph Roscoe	1,021	2006-12
Ondansetron Versus Aprepitant Plus Ondansetron for Emesis NCT00954941	Phase 2	Completed	M.D. Anderson Cancer Center	100	2009-11 → 2015-05
Aprepitant Effects in Intravenous Heroin Dependence NCT01527994	Phase 1	Completed	NYU Langone Health	64	2012-01 → 2015-02

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain19 active DMFs2 inactive

15 active API suppliers hold Drug Master Files for this ingredient.

ALIVUS LIFE SCIENCES LTDAPREPITANT USP

DMF 203812007

DR REDDYS LABORATORIES LTDAPREPITANT USP

DMF 213452008

MSN PHARMACHEM PRIVATE LTDAPREPITANT USP (ROUTE CODE - AP)

DMF 248352011

HETERO DRUGS LTDAPREPITANT

DMF 255722011

PIRAMAL PHARMA LTDAPREPITANT

DMF 260652012

JUBILANT BIOSYS LTDAPREPITANT USP

DMF 268522013

MSN PHARMACHEM PRIVATE LTDAPREPITANT USP (FORM-II) [ROUTE CODE - "AP2"]

DMF 272142013

ALIVUS LIFE SCIENCES LTDAPREPITANT USP (BO74 PROCESS)

DMF 276102014

OLON SPAAPREPITANT

DMF 277842013

MSN PHARMACHEM PRIVATE LTDAPREPITANT USP (FORM-I) [ROUTE CODE "FA"]

DMF 291212015

SOLARA ACTIVE PHARMA SCIENCES LTDAPREPITANT

DMF 292152015

PHARMATHEN SAAPREPITANT

DMF 322032017

WISDOM PHARMACEUTICAL CO LTDAPREPITANT

DMF 331752018

VIWIT PHARMACEUTICAL CO LTDAPREPITANT

DMF 332662019

INKE SAAPREPITANT

DMF 354972022

WISDOM PHARMACEUTICAL CO LTDAPREPITANT (FOSAPREPITANT DIMEGLUMINE INTERMEDIATE)

DMF 380592023

SICHUAN KELUN PHARMACEUTICAL CO LTDAPREPITANT

DMF 393442025

SHANDONG ANXIN PHARMACEUTICAL CO LTDAPREPITANT (NON-STERILE API)

DMF 396412024

MAHI DRUGS PRIVATE LTDAPREPITANT USP

DMF 406242024

VIWIT PHARMACEUTICAL CO LTDInactiveAPREPITANT (DRUG SUBSTANCE, NON-STERILE)

DMF 257152012

VIWIT PHARMACEUTICAL CO LTDInactiveAPREPITANT

DMF 288662014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 17, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 130MG/18ML (7.2MG/ML)

RLD

0 patents0 exclusivities▴

EMULSION;INTRAVENOUS | Approved: Jun 16, 2026

No patent or exclusivity listings for this strength.