Viewing data from:

POSFREA

NDA

PALONOSETRON HYDROCHLORIDE | N203050 | AVYXA HOLDINGS LLC

2 strengths0 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
HELSINN HEALTHCARE S.A. et al v. DR. REDDY'S LABORATORIES, LTD. et al 2:2014cv04274 1 patentANDA 201533palonosetron hydrochloride	D.N.J.	2014-07-07	Terminated 2019-12-06	—
HELSINN HEALTHCARE S.A. et al v. DR. REDDY'S LABORATORIES, LTD. et al 3:2012cv02867 1 patentpalonosetron hydrochloride	D.N.J.	2012-05-11	Terminated 2017-03-06	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain15 active DMFs5 inactive

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

HAS HEALTHCARE ADVANCED SYNTHESIS SAPALONOSETRON HYDROCHLORIDE USP

DMF 160632002

NEULAND LABORATORIES LTDPALONOSETRON HYDROCHLORIDE

DMF 211232007

ALP PHARM BEIJING CO LTDPALONOSETRON HYDROCHLORIDE

DMF 232092009

TAPI NL BVPALONOSETRON HYDROCHLORIDE

DMF 233322009

DR REDDYS LABORATORIES LTDPALONOSETRON HYDROCHLORIDE USP

DMF 235902010

ROLABO OUTSOURCING SLPALONOSETRON HYDROCHLORIDE

DMF 244972010

QILU PHARMACEUTICAL CO LTDPALONOSETRON HYDROCHLORIDE USP (NON STERILE API)

DMF 246612011

EMCURE PHARMACEUTICALS LTDPALONOSETRON HYDROCHLORIDE USP

DMF 247842011

WAVELENGTH ENTERPRISES LTDPALONOSETRON HYDROCHLORIDE

DMF 247982011

APITORIA PHARMA PRIVATE LTDPALONOSETRON HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)

DMF 259762012

MSN LABORATORIES PRIVATE LTDPALONOSETRON HYDROCHLORIDE USP [ROUTE CODE PI]

DMF 267842013

CIPLA LTDPALONOSETRON HYDROCHLORIDE USP

DMF 275282013

USV PRIVATE LTDPALONOSETRON HYDROCHLORIDE

DMF 280882015

TYCHE INDUSTRIES LTDPALONOSETRON HYDROCHLORIDE

DMF 293302015

WOCKHARDT BIO AGPALONOSETRON HYDROCHLORIDE USP

DMF 309552016

CATALENT PHARMA SOLUTIONS LLCInactivePALONOSETRON HYDROCHLORIDE 0.50 MG SOFTGELS

DMF 181872005

GLENMARK PHARMACEUTICALS LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 243512010

RANBAXY LABORATORIES LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 244482010

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 265612012

KYONGBO PHARMACEUTICAL CO LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 336132019

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Apr 28, 2025	SUPPL -3	View Letter (PDF)
Jul 18, 2024	SUPPL -2	View Letter (PDF)
Mar 3, 2016	ORIG -1	View Letter (PDF)
Nov 6, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Mar 1, 2016

No patent or exclusivity listings for this strength.

#002 — EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Mar 1, 2016