Orange Book product · Brand (NDA)

INCIVEK

TELAPREVIR

Brand (NDA)NDA 201917DISCN VERTEX PHARMS

May 23, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 23, 2011
15 yr 4 mo ago
Today
Patent 8431615 expires
Listed method-of-use patent (U-1398) expiration.
May 30, 2028
in 2 yr

Active ingredient

TELAPREVIR

Strength

375MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 201917

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Reference standard (RS)

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8431615	May 30, 2028	in 2 yr	U-1398