Applicant, as named in the Orange Book

Astellas

Part of Astellas Pharma

Company and ticker: cliffwatch mapping, checked against SEC EDGAR

Next listed expiry: Lexiscan on 2 Feb 2027. 11 products with live protection, 2 without.

Products with listed protection

Drug	Ingredient	Earliest generic entry	Basis
Lexiscan NDA 022161 regadenoson	regadenoson	2 Feb 2027 patent	patent
Prograf NDA 050708 · 3 strengths tacrolimus	tacrolimus	16 Jul 2028 exclusivity	exclusivity
Prograf NDA 210115 · 2 strengths tacrolimus	tacrolimus	16 Jul 2028 exclusivity	exclusivity
Prograf NDA 050709 tacrolimus	tacrolimus	16 Jul 2028 exclusivity	exclusivity
Cresemba NDA 207500 · 2 strengths isavuconazonium sulfate	isavuconazonium sulfate	8 Jun 2031 exclusivity	exclusivity
Cresemba NDA 207501 isavuconazonium sulfate	isavuconazonium sulfate	8 Jun 2031 exclusivity	exclusivity
Veozah NDA 216578 fezolinetant	fezolinetant	28 Mar 2034 patent	patent
Izervay NDA 217225 avacincaptad pegol sodium	avacincaptad pegol sodium	11 Jul 2034 patent, carve-out possible	patent, carve-out possible
Xospata NDA 211349 gilteritinib fumarate	gilteritinib fumarate	1 Jul 2036 patent	patent
Xtandi NDA 213674 · 2 strengths enzalutamide	enzalutamide	23 Feb 2037 patent, carve-out possible	patent, carve-out possible
Xtandi NDA 203415 enzalutamide	enzalutamide	23 Feb 2037 patent, carve-out possible	patent, carve-out possible

Mycamine · Generic approved · ANDA 219518, Yichang HumanwellApproved 24 Feb 2026Detected 25 Oct 2026
Ambisome · Generic approved · ANDA 220139, Qilu Pharm HainanApproved 14 Oct 2026Detected 25 Oct 2026
Mycamine · Generic approved · ANDA 219712, Hisun Pharm HangzhouApproved 21 Jan 2026Detected 25 Oct 2026
Xtandi · First generic approved · ANDA 216068, SandozApproved 20 Apr 2026Detected 25 Oct 2026
Xtandi · Generic approved · ANDA 216068, SandozApproved 20 Apr 2026Detected 25 Oct 2026
Mycamine · Generic approved · ANDA 220296, AspiroApproved 17 Mar 2026Detected 25 Oct 2026
Xtandi · Exclusivity expires within 90 days I-926Exclusivity expires 17 Nov 2026Detected 24 Oct 2026
Xtandi · Exclusivity expires within 90 days I-926Exclusivity expires 17 Nov 2026Detected 24 Oct 2026
Lexiscan · Enters 12-month window basis: patentListed date 2 Feb 2027Detected 24 Oct 2026
Cresemba · Exclusivity expires within 90 days NPPExclusivity expires 8 Dec 2026Detected 24 Oct 2026
Xtandi · Exclusivity expires within 90 days I-926Exclusivity expires 17 Nov 2026Detected 24 Oct 2026
Cresemba · Exclusivity expires within 90 days NPPExclusivity expires 8 Dec 2026Detected 24 Oct 2026
Cresemba · Exclusivity expires within 90 days NPPExclusivity expires 8 Dec 2026Detected 24 Oct 2026

Products without listed protection (2)

Drug	Ingredient	Earliest generic entry	Basis
Ambisome NDA 050740 amphotericin b	amphotericin b	open now no listed protection	no listed protection
Astagraf Xl NDA 204096 · 3 strengths tacrolimus	tacrolimus	open now no listed protection	no listed protection