Applicant, as named in the Orange Book

Cosette

Next listed expiry: Zipsor on 24 Feb 2029. 3 products with live protection, 13 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Zipsor diclofenac potassium	diclofenac potassium	022202	24 Feb 2029	patent, carve-out possible
Sympazan · 3 strengths clobazam	clobazam	210833	31 Jan 2040	patent
Vyleesi (Autoinjector) bremelanotide acetate	bremelanotide acetate	210557	29 Apr 2041	patent, carve-out possible

Recent events

25 Oct 2026Benicar Hct · Generic approved 13 Apr 2026
25 Oct 2026Tribenzor · Generic approved 24 Nov 2025
25 Oct 2026Tribenzor · Generic approved 6 Oct 2025
25 Oct 2026Benicar Hct · Generic approved 31 Mar 2026
25 Oct 2026Benicar Hct · Generic approved 26 Sep 2025
25 Oct 2026Evoxac · Generic approved 11 Mar 2026

Products without listed protection (13)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Ambien · 2 strengths zolpidem tartrate	zolpidem tartrate	019908	open now	no listed protection
Ambien Cr · 2 strengths zolpidem tartrate	zolpidem tartrate	021774	open now	no listed protection
Azor · 4 strengths amlodipine besylate; olmesartan medoxomil	amlodipine besylate; olmesartan medoxomil	022100	open now	no listed protection
Benicar · 3 strengths olmesartan medoxomil	olmesartan medoxomil	021286	open now	no listed protection
Benicar Hct · 3 strengths hydrochlorothiazide; olmesartan medoxomil	hydrochlorothiazide; olmesartan medoxomil	021532	open now	no listed protection
Cambia diclofenac potassium	diclofenac potassium	022165	open now	no listed protection
Effient · 2 strengths prasugrel hydrochloride	prasugrel hydrochloride	022307	open now	no listed protection
Evoxac cevimeline hydrochloride	cevimeline hydrochloride	020989	open now	no listed protection
Indocin indomethacin	indomethacin	018332	open now	no listed protection
Sprix ketorolac tromethamine	ketorolac tromethamine	022382	open now	no listed protection
Tribenzor · 5 strengths amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	200175	open now	no listed protection
Welchol colesevelam hydrochloride	colesevelam hydrochloride	021176	open now	no listed protection
Welchol colesevelam hydrochloride	colesevelam hydrochloride	022362	open now	no listed protection