Applicant, as named in the Orange Book

Legacy

Next listed expiry: Brisdelle on 6 Apr 2029. 4 products with live protection, 11 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Brisdelle paroxetine mesylate	paroxetine mesylate	204516	6 Apr 2029	patent
Naftin naftifine hydrochloride	naftifine hydrochloride	204286	31 Jan 2033	patent
Esbriet pirfenidone	pirfenidone	022535	30 Aug 2033	patent, carve-out possible
Esbriet · 2 strengths pirfenidone	pirfenidone	208780	28 Mar 2037	patent

Recent events

Esbriet · Generic approved · ANDA 212597, Aurobindo PharmaApproved 20 Apr 2026Detected 25 Oct 2026

Products without listed protection (11)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Betapace · 4 strengths sotalol hydrochloride	sotalol hydrochloride	019865	open now	no listed protection
Betapace Af · 3 strengths sotalol hydrochloride	sotalol hydrochloride	021151	open now	no listed protection
Cloderm clocortolone pivalate	clocortolone pivalate	017765	open now	no listed protection
Ethyol amifostine	amifostine	020221	open now	no listed protection
Imuran azathioprine	azathioprine	016324	open now	no listed protection
Lotronex · 2 strengths alosetron hydrochloride	alosetron hydrochloride	021107	open now	no listed protection
Motofen atropine sulfate; difenoxin hydrochloride	atropine sulfate; difenoxin hydrochloride	017744	open now	no listed protection
Naftin naftifine hydrochloride	naftifine hydrochloride	019599	open now	no listed protection
Ridaura auranofin	auranofin	018689	open now	no listed protection
Zanaflex tizanidine hydrochloride	tizanidine hydrochloride	020397	open now	no listed protection
Zanaflex · 3 strengths tizanidine hydrochloride	tizanidine hydrochloride	021447	open now	no listed protection