Details for New Drug Application (NDA): 207793

NDA 207793 describes ONIVYDE, which is a drug marketed by Ipsen and is included in one NDA. It is available from one supplier. There are nineteen patents protecting this drug. Additional details are available on the ONIVYDE profile page.

The generic ingredient in ONIVYDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

Summary for 207793

Tradename:	ONIVYDE
Applicant:	Ipsen
Ingredient:	irinotecan hydrochloride
Patents:	19

Pharmacology for NDA: 207793

Mechanism of Action

Topoisomerase Inhibitors

Suppliers and Packaging for NDA: 207793

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793	NDA	Ipsen Biopharmaceuticals, Inc.	15054-0043	15054-0043-1	1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE, LIPOSOMAL;INTRAVENOUS			Strength	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)
Approval Date:	Oct 22, 2015	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Feb 13, 2031
Regulatory Exclusivity Use:	FOR FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA
Regulatory Exclusivity Expiration:	Feb 13, 2027
Regulatory Exclusivity Use:	IN COMBINATION WITH OXALIPLATIN, FLUOROURACIL AND LEUCOVORIN, FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA
Patent:		Patent Expiration:	Oct 15, 2036	Product Flag?	Y	Substance Flag?		Delist Request?

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