36 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2026 - 2027
Loss of Exclusivity / End of Market Exclusivity Period dates
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Friedman, Yali, "36 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 www.drugpatentwatch.com/p/nce-1/.
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These NCE-1 dates indicate the first opportunity for generic drug companies to file Abbreviated New Drug Applications (ANDAs) for generic entry into branded drug markets. Generic launch is dependent on many factors, including FDA approval and patents. This information is provided as a rough estimate of generic application, and does not indicate when generics will launch. For more information see the complete DrugPatentWatch database.
When can drug patent challenges be filed against REZLIDHIA?
Generic name: olutasidenib
NCE-1 Date: December 2026
REZLIDHIA is a drug marketed by Rigel Pharms. There are fourteen patents protecting this drug.There has been litigation on patents covering REZLIDHIA
See drug price trends for REZLIDHIA.
The generic ingredient in REZLIDHIA is olutasidenib. Additional details are available on the olutasidenib profile page.
When can drug patent challenges be filed against KRAZATI?
Generic name: adagrasib
NCE-1 Date: December 2026
KRAZATI is a drug marketed by Bristol. There are five patents protecting this drug.
See drug price trends for KRAZATI.
The generic ingredient in KRAZATI is adagrasib. Additional details are available on the adagrasib profile page.
When can drug patent challenges be filed against SUNLENCA?
Generic name: lenacapavir sodium
NCE-1 Date: December 2026
SUNLENCA is a drug marketed by Gilead Sciences Inc. There are six patents protecting this drug.
See drug price trends for SUNLENCA.
The generic ingredient in SUNLENCA is lenacapavir sodium. Additional details are available on the lenacapavir sodium profile page.
When can drug patent challenges be filed against YEZTUGO?
Generic name: lenacapavir sodium
NCE-1 Date: December 2026
YEZTUGO is a drug marketed by Gilead Sciences Inc. There are five patents protecting this drug.
The generic ingredient in YEZTUGO is lenacapavir sodium. Additional details are available on the lenacapavir sodium profile page.
When can drug patent challenges be filed against XENOVIEW?
Generic name: xenon xe-129 hyperpolarized
NCE-1 Date: December 2026
XENOVIEW is a drug marketed by Polarean. There are two patents protecting this drug.
The generic ingredient in XENOVIEW is xenon xe-129 hyperpolarized. Additional details are available on the xenon xe-129 hyperpolarized profile page.
When can drug patent challenges be filed against BRENZAVVY?
Generic name: bexagliflozin
NCE-1 Date: January 2027
BRENZAVVY is a drug marketed by Theracosbio. There are seven patents protecting this drug.There has been litigation on patents covering BRENZAVVY
The generic ingredient in BRENZAVVY is bexagliflozin. Additional details are available on the bexagliflozin profile page.
When can drug patent challenges be filed against JAYPIRCA?
Generic name: pirtobrutinib
NCE-1 Date: January 2027
JAYPIRCA is a drug marketed by Loxo Oncol. There are seven patents protecting this drug.
See drug price trends for JAYPIRCA.
The generic ingredient in JAYPIRCA is pirtobrutinib. Additional details are available on the pirtobrutinib profile page.
When can drug patent challenges be filed against ORSERDU?
Generic name: elacestrant hydrochloride
NCE-1 Date: January 2027
ORSERDU is a drug marketed by Stemline Therap. There are seven patents protecting this drug.There has been litigation on patents covering ORSERDU
See drug price trends for ORSERDU.
The generic ingredient in ORSERDU is elacestrant hydrochloride. Additional details are available on the elacestrant hydrochloride profile page.
When can drug patent challenges be filed against JESDUVROQ?
Generic name: daprodustat
NCE-1 Date: February 2027
JESDUVROQ is a drug marketed by Glaxosmithkline. There are six patents protecting this drug.
See drug price trends for JESDUVROQ.
The generic ingredient in JESDUVROQ is daprodustat. Additional details are available on the daprodustat profile page.
When can drug patent challenges be filed against FILSPARI?
Generic name: sparsentan
NCE-1 Date: February 2027
FILSPARI is a drug marketed by Travere. There are two patents protecting this drug.
See drug price trends for FILSPARI.
The generic ingredient in FILSPARI is sparsentan. Additional details are available on the sparsentan profile page.
When can drug patent challenges be filed against SKYCLARYS?
Generic name: omaveloxolone
NCE-1 Date: February 2027
SKYCLARYS is a drug marketed by Biogen Us. There are seven patents protecting this drug.
See drug price trends for SKYCLARYS.
The generic ingredient in SKYCLARYS is omaveloxolone. Additional details are available on the omaveloxolone profile page.
When can drug patent challenges be filed against ZAVZPRET?
Generic name: zavegepant hydrochloride
NCE-1 Date: March 2027
See drug price trends for ZAVZPRET.
The generic ingredient in ZAVZPRET is zavegepant hydrochloride. Additional details are available on the zavegepant hydrochloride profile page.
When can drug patent challenges be filed against DAYBUE STIX?
Generic name: trofinetide
NCE-1 Date: March 2027
DAYBUE STIX is a drug marketed by Acadia Pharms Inc. There are four patents protecting this drug.
The generic ingredient in DAYBUE STIX is trofinetide. Additional details are available on the trofinetide profile page.
When can drug patent challenges be filed against DAYBUE?
Generic name: trofinetide
NCE-1 Date: March 2027
DAYBUE is a drug marketed by Acadia Pharms Inc. There are four patents protecting this drug.
See drug price trends for DAYBUE.
The generic ingredient in DAYBUE is trofinetide. Additional details are available on the trofinetide profile page.
When can drug patent challenges be filed against REZZAYO?
Generic name: rezafungin acetate
NCE-1 Date: March 2027
REZZAYO is a drug marketed by Mundipharma. There are seven patents protecting this drug.
See drug price trends for REZZAYO.
The generic ingredient in REZZAYO is rezafungin acetate. Additional details are available on the rezafungin acetate profile page.
When can drug patent challenges be filed against JOENJA?
Generic name: leniolisib phosphate
NCE-1 Date: March 2027
JOENJA is a drug marketed by Pharming. There is one patent protecting this drug.
See drug price trends for JOENJA.
The generic ingredient in JOENJA is leniolisib phosphate. Additional details are available on the leniolisib phosphate profile page.
When can drug patent challenges be filed against QALSODY?
Generic name: tofersen
NCE-1 Date: April 2027
QALSODY is a drug marketed by Biogen Ma. There are three patents protecting this drug.
See drug price trends for QALSODY.
The generic ingredient in QALSODY is tofersen. Additional details are available on the tofersen profile page.
When can drug patent challenges be filed against VEOZAH?
Generic name: fezolinetant
NCE-1 Date: May 2027
See drug price trends for VEOZAH.
The generic ingredient in VEOZAH is fezolinetant. Additional details are available on the fezolinetant profile page.
When can drug patent challenges be filed against MIEBO?
Generic name: perfluorohexyloctane
NCE-1 Date: May 2027
See drug price trends for MIEBO.
The generic ingredient in MIEBO is perfluorohexyloctane. Additional details are available on the perfluorohexyloctane profile page.
When can drug patent challenges be filed against XACDURO (COPACKAGED)?
Generic name: durlobactam sodium; durlobactam sodium; sulbactam sodium
NCE-1 Date: May 2027
XACDURO (COPACKAGED) is a drug marketed by Entasis Therap. There are four patents protecting this drug.There has been litigation on patents covering XACDURO (COPACKAGED)
The generic ingredient in XACDURO (COPACKAGED) is durlobactam sodium; durlobactam sodium; sulbactam sodium. Additional details are available on the durlobactam sodium; durlobactam sodium; sulbactam sodium profile page.
When can drug patent challenges be filed against PAXLOVID (COPACKAGED)?
Generic name: nirmatrelvir; ritonavir
NCE-1 Date: May 2027
PAXLOVID (COPACKAGED) is a drug marketed by Pfizer. There are two patents protecting this drug.There has been litigation on patents covering PAXLOVID (COPACKAGED)
The generic ingredient in PAXLOVID (COPACKAGED) is nirmatrelvir; ritonavir. Additional details are available on the nirmatrelvir; ritonavir profile page.
When can drug patent challenges be filed against POSLUMA?
Generic name: flotufolastat f-18 gallium
NCE-1 Date: May 2027
POSLUMA is a drug marketed by Blue Earth. There are six patents protecting this drug.
See drug price trends for POSLUMA.
The generic ingredient in POSLUMA is flotufolastat f-18 gallium. Additional details are available on the flotufolastat f-18 gallium profile page.
When can drug patent challenges be filed against INPEFA?
Generic name: sotagliflozin
NCE-1 Date: May 2027
See drug price trends for INPEFA.
The generic ingredient in INPEFA is sotagliflozin. Additional details are available on the sotagliflozin profile page.
When can drug patent challenges be filed against LITFULO?
Generic name: ritlecitinib tosylate
NCE-1 Date: June 2027
LITFULO is a drug marketed by Pfizer. There are three patents protecting this drug.
See drug price trends for LITFULO.
The generic ingredient in LITFULO is ritlecitinib tosylate. Additional details are available on the ritlecitinib tosylate profile page.
When can drug patent challenges be filed against VANFLYTA?
Generic name: quizartinib dihydrochloride
NCE-1 Date: July 2027
VANFLYTA is a drug marketed by Daiichi Sankyo Inc. There are eleven patents protecting this drug.
See drug price trends for VANFLYTA.
The generic ingredient in VANFLYTA is quizartinib dihydrochloride. Additional details are available on the quizartinib dihydrochloride profile page.
When can drug patent challenges be filed against YCANTH?
Generic name: cantharidin
NCE-1 Date: July 2027
YCANTH is a drug marketed by Verrica Pharms. There are four patents protecting this drug.There has been litigation on patents covering YCANTH
See drug price trends for YCANTH.
The generic ingredient in YCANTH is cantharidin. Additional details are available on the cantharidin profile page.
When can drug patent challenges be filed against XDEMVY?
Generic name: lotilaner
NCE-1 Date: July 2027
XDEMVY is a drug marketed by Tarsus. There are nine patents protecting this drug.
See drug price trends for XDEMVY.
The generic ingredient in XDEMVY is lotilaner. Additional details are available on the lotilaner profile page.
When can drug patent challenges be filed against SOHONOS?
Generic name: palovarotene
NCE-1 Date: August 2027
SOHONOS is a drug marketed by Ipsen. There are nine patents protecting this drug.There has been litigation on patents covering SOHONOS
See drug price trends for SOHONOS.
The generic ingredient in SOHONOS is palovarotene. Additional details are available on the palovarotene profile page.
When can drug patent challenges be filed against APHEXDA?
Generic name: motixafortide acetate
NCE-1 Date: September 2027
APHEXDA is a drug marketed by Ayrmid Pharma. There are two patents protecting this drug.
The generic ingredient in APHEXDA is motixafortide acetate. Additional details are available on the motixafortide acetate profile page.
When can drug patent challenges be filed against OJJAARA?
Generic name: momelotinib dihydrochloride
NCE-1 Date: September 2027
OJJAARA is a drug marketed by Glaxosmithkline. There are five patents protecting this drug.
See drug price trends for OJJAARA.
The generic ingredient in OJJAARA is momelotinib dihydrochloride. Additional details are available on the momelotinib dihydrochloride profile page.
When can drug patent challenges be filed against EXXUA?
Generic name: gepirone hydrochloride
NCE-1 Date: September 2027
EXXUA is a drug marketed by Fabre Kramer. There is one patent protecting this drug.
The generic ingredient in EXXUA is gepirone hydrochloride. Additional details are available on the gepirone hydrochloride profile page.
When can drug patent challenges be filed against RIVFLOZA?
Generic name: nedosiran sodium
NCE-1 Date: September 2027
RIVFLOZA is a drug marketed by Novo. There are six patents protecting this drug.
The generic ingredient in RIVFLOZA is nedosiran sodium. Additional details are available on the nedosiran sodium profile page.
When can drug patent challenges be filed against VELSIPITY?
Generic name: etrasimod arginine
NCE-1 Date: October 2027
VELSIPITY is a drug marketed by Pfizer. There are nine patents protecting this drug.There has been litigation on patents covering VELSIPITY
See drug price trends for VELSIPITY.
The generic ingredient in VELSIPITY is etrasimod arginine. Additional details are available on the etrasimod arginine profile page.
When can drug patent challenges be filed against ZILBRYSQ?
Generic name: zilucoplan sodium
NCE-1 Date: October 2027
ZILBRYSQ is a drug marketed by Ucb Inc. There are nine patents protecting this drug.
See drug price trends for ZILBRYSQ.
The generic ingredient in ZILBRYSQ is zilucoplan sodium. Additional details are available on the zilucoplan sodium profile page.
When can drug patent challenges be filed against AGAMREE?
Generic name: vamorolone
NCE-1 Date: October 2027
AGAMREE is a drug marketed by Catalyst Pharms. There are seven patents protecting this drug.
See drug price trends for AGAMREE.
The generic ingredient in AGAMREE is vamorolone. Additional details are available on the vamorolone profile page.
When can drug patent challenges be filed against ZURZUVAE?
Generic name: zuranolone
NCE-1 Date: October 2027
ZURZUVAE is a drug marketed by Biogen. There are five patents protecting this drug.There has been litigation on patents covering ZURZUVAE
See drug price trends for ZURZUVAE.
The generic ingredient in ZURZUVAE is zuranolone. Additional details are available on the zuranolone profile page.
