Orange Book product · Brand (NDA)

ONIVYDE

IRINOTECAN HYDROCHLORIDE

Brand (NDA)NDA 207793RX IPSEN

View IRINOTECAN HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Oct 22, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Oct 22, 2015
10 yr 10 mo ago
Today
Patent 8329213 expires
Listed drug substance patent expiration.
Jan 06, 2027
in 7 mo
Exclusivity ends · I-932
New indication exclusivity (3 years)
Feb 13, 2027
in 8 mo
Patent 8147867 expires
Listed drug substance patent expiration.
Aug 29, 2028
in 2 yr 3 mo
Exclusivity ends · ODE-463
Orphan-drug exclusivity (7 years)
Feb 13, 2031
in 4 yr 9 mo
Patent 10980795 expires
Listed method-of-use patent (U-1848) expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 11369597 expires
Listed method-of-use patent (U-1848) expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 12364691 expires
Listed method-of-use patent (U-1848) expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 9339497 expires
Listed method-of-use patent (U-1848) expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 9364473 expires
Listed method-of-use patent (U-1856) expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 9452162 expires
Listed method-of-use patent (U-1899) expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 9492442 expires
Listed method-of-use patent (U-1917) expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 9492442 expires
Listed method-of-use patent (U-1899) expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 9492442 expires
Listed method-of-use patent (U-1848) expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 9717724 expires
Listed method-of-use patent (U-2091) expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 9717724 expires
Listed method-of-use patent (U-1848) expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 11344552 expires
Listed method-of-use patent (U-3824) expiration.
Aug 19, 2036
in 10 yr 4 mo
Patent 10456360 expires
Listed drug product patent expiration.
Oct 15, 2036
in 10 yr 6 mo
Patent 10993914 expires
Listed drug product patent expiration.
Oct 15, 2036
in 10 yr 6 mo
Patent 12059497 expires
Listed drug product patent expiration.
Oct 15, 2036
in 10 yr 6 mo

Pharmaceutical detail

Active ingredient

IRINOTECAN HYDROCHLORIDE

Strength

EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)

Dosage form

INJECTABLE, LIPOSOMAL

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 207793

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (2)

I-932New indication exclusivity (3 years)
Feb 13, 2027
in 8 mo
ODE-463Orphan-drug exclusivity (7 years)
Feb 13, 2031
in 4 yr 9 mo

Listed patents (17)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8329213	Jan 06, 2027	in 7 mo	SubstanceProduct
8147867	Aug 29, 2028	in 2 yr 3 mo	SubstanceProduct
10980795	Jun 12, 2033	in 7 yr 1 mo	U-1848
11369597	Jun 12, 2033	in 7 yr 1 mo	U-1848
12364691	Jun 12, 2033	in 7 yr 1 mo	U-1848
9339497	Jun 12, 2033	in 7 yr 1 mo	U-1848
9364473	Jun 12, 2033	in 7 yr 1 mo	U-1856
9452162	Jun 12, 2033	in 7 yr 1 mo	U-1899
9492442	Jun 12, 2033	in 7 yr 1 mo	U-1917
9492442	Jun 12, 2033	in 7 yr 1 mo	U-1899
9492442	Jun 12, 2033	in 7 yr 1 mo	U-1848
9717724	Jun 12, 2033	in 7 yr 1 mo	U-2091
9717724	Jun 12, 2033	in 7 yr 1 mo	U-1848
11344552	Aug 19, 2036	in 10 yr 4 mo	U-3824
10456360	Oct 15, 2036	in 10 yr 6 mo	Product
10993914	Oct 15, 2036	in 10 yr 6 mo	Product
12059497	Oct 15, 2036	in 10 yr 6 mo	Product

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