Orange Book product · Brand (NDA)

TOLSURA

ITRACONAZOLE

Brand (NDA)NDA 208901RX MAYNE PHARMA

Dec 11, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 11, 2018
7 yr 8 mo ago
Today
Patent 10463740 expires
Listed drug product patent expiration.
Jun 21, 2033
in 7 yr 1 mo
Patent 10806792 expires
Listed drug product patent expiration.
Jun 21, 2033
in 7 yr 1 mo
Patent 8921374 expires
Listed drug product patent expiration.
Jun 21, 2033
in 7 yr 1 mo
Patent 9272046 expires
Listed drug product patent expiration.
Jun 21, 2033
in 7 yr 1 mo
Patent 9713642 expires
Listed method-of-use patent (U-2453) expiration.
Jun 21, 2033
in 7 yr 1 mo

Active ingredient

ITRACONAZOLE

Strength

65MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 208901

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10463740	Jun 21, 2033	in 7 yr 1 mo	ProductU-2453
10806792	Jun 21, 2033	in 7 yr 1 mo	Product
8921374	Jun 21, 2033	in 7 yr 1 mo	Product
9272046	Jun 21, 2033	in 7 yr 1 mo	Product
9713642	Jun 21, 2033	in 7 yr 1 mo	U-2453