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

Recent events

Paxil · Generic approved · ANDA 219954, Annora PharmaApproved 5 Mar 2026Detected 25 Oct 2026
Paxil Cr · Generic approved · ANDA 217280, AlembicApproved 24 Sep 2025Detected 25 Oct 2026
Vibativ · Enters 12-month window basis: patentListed date 1 Jan 2027Detected 24 Oct 2026
Vibativ · Enters 12-month window basis: patentListed date 1 Jan 2027Detected 24 Oct 2026

Products without listed protection (5)

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