Applicant, as named in the Orange Book

Apotex

Next listed expiry: Vibativ on 1 Jan 2027. 5 products with live protection, 5 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Vibativ telavancin hydrochloride	telavancin hydrochloride	022110	1 Jan 2027	patent
Caldolor · 2 strengths ibuprofen	ibuprofen	022348	16 Mar 2032	patent, carve-out possible
Acetadote acetylcysteine	acetylcysteine	021539	6 Apr 2032	patent, carve-out possible
Ivra melphalan hydrochloride	melphalan hydrochloride	217110	29 Jun 2036	patent
Evdi trabectedin	trabectedin	220837	18 Feb 2043	patent

Recent events

25 Oct 2026Paxil · Generic approved 5 Mar 2026
25 Oct 2026Paxil Cr · Generic approved 24 Sep 2025
24 Oct 2026Vibativ · Enters 12-month window basis: patent1 Jan 2027
24 Oct 2026Vibativ · Enters 12-month window basis: patent1 Jan 2027

Products without listed protection (5)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Bendamustine Hydrochloride bendamustine hydrochloride	bendamustine hydrochloride	215033	open now	no listed protection
Paxil · 4 strengths paroxetine hydrochloride	paroxetine hydrochloride	020031	open now	no listed protection
Paxil Cr · 3 strengths paroxetine hydrochloride	paroxetine hydrochloride	020936	open now	no listed protection
Sancuso granisetron	granisetron	022198	open now	no listed protection
Vaprisol In 5% Dextrose In Plastic Container conivaptan hydrochloride	conivaptan hydrochloride	021697	open now	no listed protection