34 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2025 - 2026
Loss of Exclusivity / End of Market Exclusivity Period dates
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Friedman, Yali, "34 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 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 AMONDYS 45?
Generic name: casimersen
NCE-1 Date: February 2025
AMONDYS 45 is a drug marketed by Sarepta Theraps Inc. There are six patents protecting this drug.
This drug has eighty-eight patent family members in twenty-four countries.
The generic ingredient in AMONDYS 45 is casimersen. Additional details are available on the casimersen profile page.
When can drug patent challenges be filed against NULIBRY?
Generic name: fosdenopterin hydrobromide
NCE-1 Date: February 2025
NULIBRY is a drug marketed by Sentynl Theraps Inc. There is one patent protecting this drug.
This drug has ten patent family members in ten countries.
See drug price trends for NULIBRY.
The generic ingredient in NULIBRY is fosdenopterin hydrobromide. Additional details are available on the fosdenopterin hydrobromide profile page.
When can drug patent challenges be filed against FOTIVDA?
Generic name: tivozanib hydrochloride
NCE-1 Date: March 2025
FOTIVDA is a drug marketed by Aveo Pharms. There are three patents protecting this drug.
This drug has fifty-five patent family members in twenty-six countries.
See drug price trends for FOTIVDA.
The generic ingredient in FOTIVDA is tivozanib hydrochloride. Additional details are available on the tivozanib hydrochloride profile page.
When can drug patent challenges be filed against PONVORY?
Generic name: ponesimod
NCE-1 Date: March 2025
PONVORY is a drug marketed by Vanda Pharms Inc. There are six patents protecting this drug.
This drug has one hundred and forty-five patent family members in forty-one countries. There has been litigation on patents covering PONVORY
See drug price trends for PONVORY.
The generic ingredient in PONVORY is ponesimod. Additional details are available on the ponesimod profile page.
When can drug patent challenges be filed against ZEGALOGUE?
Generic name: dasiglucagon hydrochloride
NCE-1 Date: March 2025
This drug has thirty-six patent family members in twenty-seven countries.
See drug price trends for ZEGALOGUE.
The generic ingredient in ZEGALOGUE is dasiglucagon hydrochloride. Additional details are available on the dasiglucagon hydrochloride profile page.
When can drug patent challenges be filed against ZEGALOGUE (AUTOINJECTOR)?
Generic name: dasiglucagon hydrochloride
NCE-1 Date: March 2025
ZEGALOGUE (AUTOINJECTOR) is a drug marketed by Zealand Pharma. There are two patents protecting this drug.
This drug has thirty-six patent family members in twenty-seven countries.
The generic ingredient in ZEGALOGUE (AUTOINJECTOR) is dasiglucagon hydrochloride. Additional details are available on the dasiglucagon hydrochloride profile page.
When can drug patent challenges be filed against QELBREE?
Generic name: viloxazine hydrochloride
NCE-1 Date: April 2025
QELBREE is a drug marketed by Supernus Pharms. There are six patents protecting this drug.
This drug has twenty-one patent family members in seven countries. There has been litigation on patents covering QELBREE
See drug price trends for QELBREE.
The generic ingredient in QELBREE is viloxazine hydrochloride. Additional details are available on the viloxazine hydrochloride profile page.
When can drug patent challenges be filed against NEXTSTELLIS?
Generic name: drospirenone; estetrol
NCE-1 Date: April 2025
This drug has two hundred and two patent family members in forty-seven countries.
See drug price trends for NEXTSTELLIS.
The generic ingredient in NEXTSTELLIS is drospirenone; estetrol. There are eleven drug master file entries for this API. Additional details are available on the drospirenone; estetrol profile page.
When can drug patent challenges be filed against AZSTARYS?
Generic name: dexmethylphenidate hydrochloride; serdexmethylphenidate chloride
NCE-1 Date: May 2025
This drug has eighty-three patent family members in thirty countries.
See drug price trends for AZSTARYS.
The generic ingredient in AZSTARYS is dexmethylphenidate hydrochloride; serdexmethylphenidate chloride. There are six drug master file entries for this API. Additional details are available on the dexmethylphenidate hydrochloride; serdexmethylphenidate chloride profile page.
When can drug patent challenges be filed against SYFOVRE?
Generic name: pegcetacoplan
NCE-1 Date: May 2025
SYFOVRE is a drug marketed by Apellis Pharms. There are eleven patents protecting this drug.
This drug has one hundred and eighty-one patent family members in twenty-seven countries.
See drug price trends for SYFOVRE.
The generic ingredient in SYFOVRE is pegcetacoplan. Additional details are available on the pegcetacoplan profile page.
When can drug patent challenges be filed against EMPAVELI?
Generic name: pegcetacoplan
NCE-1 Date: May 2025
EMPAVELI is a drug marketed by Apellis Pharms. There are ten patents protecting this drug.
This drug has one hundred and forty-nine patent family members in twenty-seven countries.
See drug price trends for EMPAVELI.
The generic ingredient in EMPAVELI is pegcetacoplan. Additional details are available on the pegcetacoplan profile page.
When can drug patent challenges be filed against PYLARIFY?
Generic name: piflufolastat f-18
NCE-1 Date: May 2025
PYLARIFY is a drug marketed by Progenics Pharms Inc. There are six patents protecting this drug.
This drug has one hundred patent family members in twenty-six countries.
See drug price trends for PYLARIFY.
The generic ingredient in PYLARIFY is piflufolastat f-18. Additional details are available on the piflufolastat f-18 profile page.
When can drug patent challenges be filed against LUMAKRAS?
Generic name: sotorasib
NCE-1 Date: May 2025
LUMAKRAS is a drug marketed by Amgen Inc. There are four patents protecting this drug.
This drug has one hundred and twenty-three patent family members in thirty-seven countries.
See drug price trends for LUMAKRAS.
The generic ingredient in LUMAKRAS is sotorasib. Additional details are available on the sotorasib profile page.
When can drug patent challenges be filed against LYBALVI?
Generic name: olanzapine; samidorphan l-malate
NCE-1 Date: May 2025
This drug has eighty-seven patent family members in twenty-eight countries.
See drug price trends for LYBALVI.
The generic ingredient in LYBALVI is olanzapine; samidorphan l-malate. There are thirty-three drug master file entries for this API. Additional details are available on the olanzapine; samidorphan l-malate profile page.
When can drug patent challenges be filed against TRUSELTIQ?
Generic name: infigratinib phosphate
NCE-1 Date: May 2025
TRUSELTIQ is a drug marketed by Helsinn Hlthcare. There are four patents protecting this drug.
This drug has one hundred and thirty-five patent family members in forty countries.
See drug price trends for TRUSELTIQ.
The generic ingredient in TRUSELTIQ is infigratinib phosphate. Additional details are available on the infigratinib phosphate profile page.
When can drug patent challenges be filed against BREXAFEMME?
Generic name: ibrexafungerp citrate
NCE-1 Date: June 2025
This drug has fifty-five patent family members in twenty-six countries.
See drug price trends for BREXAFEMME.
The generic ingredient in BREXAFEMME is ibrexafungerp citrate. Additional details are available on the ibrexafungerp citrate profile page.
When can drug patent challenges be filed against KERENDIA?
Generic name: finerenone
NCE-1 Date: July 2025
This drug has ninety-three patent family members in forty-seven countries.
See drug price trends for KERENDIA.
The generic ingredient in KERENDIA is finerenone. Additional details are available on the finerenone profile page.
When can drug patent challenges be filed against FEXINIDAZOLE?
Generic name: fexinidazole
NCE-1 Date: July 2025
FEXINIDAZOLE is a drug marketed by Sanofi.
This drug has ninety-three patent family members in forty-seven countries.
The generic ingredient in FEXINIDAZOLE is fexinidazole. Additional details are available on the fexinidazole profile page.
When can drug patent challenges be filed against REZUROCK?
Generic name: belumosudil mesylate
NCE-1 Date: July 2025
REZUROCK is a drug marketed by Kadmon Pharms Llc. There are five patents protecting this drug.
This drug has forty-nine patent family members in twenty-seven countries.
See drug price trends for REZUROCK.
The generic ingredient in REZUROCK is belumosudil mesylate. Additional details are available on the belumosudil mesylate profile page.
When can drug patent challenges be filed against BYLVAY?
Generic name: odevixibat
NCE-1 Date: July 2025
BYLVAY is a drug marketed by Ipsen. There are twelve patents protecting this drug.
This drug has one hundred and fifteen patent family members in forty-two countries.
See drug price trends for BYLVAY.
The generic ingredient in BYLVAY is odevixibat. Additional details are available on the odevixibat profile page.
When can drug patent challenges be filed against WELIREG?
Generic name: belzutifan
NCE-1 Date: August 2025
WELIREG is a drug marketed by Merck Sharp Dohme. There are two patents protecting this drug.
This drug has fifty-three patent family members in twenty-eight countries.
See drug price trends for WELIREG.
The generic ingredient in WELIREG is belzutifan. Additional details are available on the belzutifan profile page.
When can drug patent challenges be filed against KORSUVA?
Generic name: difelikefalin acetate
NCE-1 Date: August 2025
KORSUVA is a drug marketed by Cara Therap. There are twelve patents protecting this drug.
This drug has fifty-two patent family members in twenty-seven countries.
See drug price trends for KORSUVA.
The generic ingredient in KORSUVA is difelikefalin acetate. Additional details are available on the difelikefalin acetate profile page.
When can drug patent challenges be filed against EXKIVITY?
Generic name: mobocertinib succinate
NCE-1 Date: September 2025
EXKIVITY is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug.
This drug has sixty-three patent family members in forty countries.
See drug price trends for EXKIVITY.
The generic ingredient in EXKIVITY is mobocertinib succinate. Additional details are available on the mobocertinib succinate profile page.
When can drug patent challenges be filed against QULIPTA?
Generic name: atogepant
NCE-1 Date: September 2025
This drug has one hundred and fourteen patent family members in forty-five countries. There has been litigation on patents covering QULIPTA
See drug price trends for QULIPTA.
The generic ingredient in QULIPTA is atogepant. Additional details are available on the atogepant profile page.
When can drug patent challenges be filed against LIVMARLI?
Generic name: maralixibat chloride
NCE-1 Date: September 2025
LIVMARLI is a drug marketed by Mirum. There are seven patents protecting this drug.
This drug has one hundred and thirty-one patent family members in twenty-three countries.
See drug price trends for LIVMARLI.
The generic ingredient in LIVMARLI is maralixibat chloride. Additional details are available on the maralixibat chloride profile page.
When can drug patent challenges be filed against TAVNEOS?
Generic name: avacopan
NCE-1 Date: October 2025
TAVNEOS is a drug marketed by Chemocentryx. There are four patents protecting this drug.
This drug has one hundred and eight patent family members in thirty-seven countries.
See drug price trends for TAVNEOS.
The generic ingredient in TAVNEOS is avacopan. Additional details are available on the avacopan profile page.
When can drug patent challenges be filed against SCEMBLIX?
Generic name: asciminib hydrochloride
NCE-1 Date: October 2025
SCEMBLIX is a drug marketed by Novartis. There are two patents protecting this drug.
This drug has eighty-six patent family members in forty-nine countries.
See drug price trends for SCEMBLIX.
The generic ingredient in SCEMBLIX is asciminib hydrochloride. Additional details are available on the asciminib hydrochloride profile page.
When can drug patent challenges be filed against VOXZOGO?
Generic name: vosoritide
NCE-1 Date: November 2025
VOXZOGO is a drug marketed by Biomarin Pharm. There are six patents protecting this drug.
This drug has eighty-five patent family members in twenty-eight countries.
See drug price trends for VOXZOGO.
The generic ingredient in VOXZOGO is vosoritide. Additional details are available on the vosoritide profile page.
When can drug patent challenges be filed against LIVTENCITY?
Generic name: maribavir
NCE-1 Date: November 2025
LIVTENCITY is a drug marketed by Takeda Pharms Usa. There is one patent protecting this drug.
See drug price trends for LIVTENCITY.
The generic ingredient in LIVTENCITY is maribavir. Additional details are available on the maribavir profile page.
When can drug patent challenges be filed against CYTALUX?
Generic name: pafolacianine sodium
NCE-1 Date: November 2025
CYTALUX is a drug marketed by On Target Labs. There are six patents protecting this drug.
This drug has thirty-five patent family members in twelve countries.
The generic ingredient in CYTALUX is pafolacianine sodium. Additional details are available on the pafolacianine sodium profile page.
When can drug patent challenges be filed against LEQVIO?
Generic name: inclisiran sodium
NCE-1 Date: December 2025
LEQVIO is a drug marketed by Novartis. There are thirteen patents protecting this drug.
This drug has two hundred and twenty-four patent family members in thirty-three countries. There has been litigation on patents covering LEQVIO
See drug price trends for LEQVIO.
The generic ingredient in LEQVIO is inclisiran sodium. Additional details are available on the inclisiran sodium profile page.
When can drug patent challenges be filed against CIBINQO?
Generic name: abrocitinib
NCE-1 Date: January 2026
This drug has sixty-five patent family members in forty-four countries.
See drug price trends for CIBINQO.
The generic ingredient in CIBINQO is abrocitinib. Additional details are available on the abrocitinib profile page.
When can drug patent challenges be filed against PYRUKYND?
Generic name: mitapivat sulfate
NCE-1 Date: February 2026
PYRUKYND is a drug marketed by Agios Pharms Inc. There are nine patents protecting this drug.
This drug has one hundred and eighty-three patent family members in forty-six countries.
See drug price trends for PYRUKYND.
The generic ingredient in PYRUKYND is mitapivat sulfate. Additional details are available on the mitapivat sulfate profile page.
When can drug patent challenges be filed against VONJO?
Generic name: pacritinib citrate
NCE-1 Date: February 2026
VONJO is a drug marketed by Sobi. There are three patents protecting this drug.
This drug has seventy-seven patent family members in twenty-seven countries.
See drug price trends for VONJO.
The generic ingredient in VONJO is pacritinib citrate. Additional details are available on the pacritinib citrate profile page.