37 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, "37 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 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-five patent family members in twenty-eight 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 and three 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 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 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-four 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 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 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 fifty-four patent family members in twenty-eight 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 FEXINIDAZOLE?
Generic name: fexinidazole
NCE-1 Date: July 2025
FEXINIDAZOLE is a drug marketed by Sanofi.
This drug has fifty-four patent family members in twenty-eight 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 BYLVAY?
Generic name: odevixibat
NCE-1 Date: July 2025
BYLVAY is a drug marketed by Ipsen. There are thirteen patents protecting this drug.
This drug has one hundred and twenty-one patent family members in forty-four 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 seventeen patent family members in thirty-eight 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-nine patent family members in thirty 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 are two patents protecting this drug.
This drug has ten patent family members in ten countries.
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 nine patents protecting this drug.
This drug has one hundred and sixty-eight patent family members in thirty-two 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-six 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-eight patent family members in twenty-eight 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.
When can drug patent challenges be filed against PLUVICTO?
Generic name: lutetium lu-177 vipivotide tetraxetan
NCE-1 Date: March 2026
PLUVICTO is a drug marketed by Novartis. There are five patents protecting this drug.
This drug has one hundred and twenty-eight patent family members in thirty-eight countries.
See drug price trends for PLUVICTO.
The generic ingredient in PLUVICTO is lutetium lu-177 vipivotide tetraxetan. There are four drug master file entries for this API. Additional details are available on the lutetium lu-177 vipivotide tetraxetan profile page.
When can drug patent challenges be filed against QUVIVIQ?
Generic name: daridorexant hydrochloride
NCE-1 Date: April 2026
This drug has eighty-eight patent family members in thirty-five countries.
See drug price trends for QUVIVIQ.
The generic ingredient in QUVIVIQ is daridorexant hydrochloride. Additional details are available on the daridorexant hydrochloride profile page.
When can drug patent challenges be filed against VIVJOA?
Generic name: oteseconazole
NCE-1 Date: April 2026
VIVJOA is a drug marketed by Mycovia Pharms. There are five patents protecting this drug.
This drug has sixty-three patent family members in twenty-two countries.
See drug price trends for VIVJOA.
The generic ingredient in VIVJOA is oteseconazole. Additional details are available on the oteseconazole profile page.
When can drug patent challenges be filed against CAMZYOS?
Generic name: mavacamten
NCE-1 Date: April 2026
CAMZYOS is a drug marketed by Bristol. There are two patents protecting this drug.
This drug has sixty-seven patent family members in thirty-nine countries.
See drug price trends for CAMZYOS.
The generic ingredient in CAMZYOS is mavacamten. Additional details are available on the mavacamten profile page.
When can drug patent challenges be filed against VOQUEZNA TRIPLE PAK?
Generic name: amoxicillin; clarithromycin; vonoprazan fumarate
NCE-1 Date: May 2026
This drug has one hundred and three patent family members in forty-three countries.
See drug price trends for VOQUEZNA TRIPLE PAK.
The generic ingredient in VOQUEZNA TRIPLE PAK is amoxicillin; clarithromycin; vonoprazan fumarate. There are forty-six drug master file entries for this API. Additional details are available on the amoxicillin; clarithromycin; vonoprazan fumarate profile page.
When can drug patent challenges be filed against VOQUEZNA DUAL PAK?
Generic name: amoxicillin; vonoprazan fumarate
NCE-1 Date: May 2026
This drug has one hundred and three patent family members in forty-three countries.
See drug price trends for VOQUEZNA DUAL PAK.
The generic ingredient in VOQUEZNA DUAL PAK is amoxicillin; vonoprazan fumarate. There are forty-six drug master file entries for this API. Additional details are available on the amoxicillin; vonoprazan fumarate profile page.
When can drug patent challenges be filed against VOQUEZNA?
Generic name: vonoprazan fumarate
NCE-1 Date: May 2026
This drug has one hundred and three patent family members in forty-three countries.
See drug price trends for VOQUEZNA.
The generic ingredient in VOQUEZNA is vonoprazan fumarate. There is one drug master file entry for this API. Additional details are available on the vonoprazan fumarate profile page.
When can drug patent challenges be filed against MOUNJARO?
Generic name: tirzepatide
NCE-1 Date: May 2026
This drug has one hundred and fifteen patent family members in forty-four countries.
See drug price trends for MOUNJARO.
The generic ingredient in MOUNJARO is tirzepatide. Additional details are available on the tirzepatide profile page.
When can drug patent challenges be filed against MOUNJARO (AUTOINJECTOR)?
Generic name: tirzepatide
NCE-1 Date: May 2026
MOUNJARO (AUTOINJECTOR) is a drug marketed by Eli Lilly And Co. There are two patents protecting this drug.
This drug has one hundred and fifteen patent family members in forty-four countries.
The generic ingredient in MOUNJARO (AUTOINJECTOR) is tirzepatide. Additional details are available on the tirzepatide profile page.
When can drug patent challenges be filed against ZEPBOUND?
Generic name: tirzepatide
NCE-1 Date: May 2026
This drug has one hundred and seventeen patent family members in forty-four countries.
See drug price trends for ZEPBOUND.
The generic ingredient in ZEPBOUND is tirzepatide. Additional details are available on the tirzepatide profile page.
When can drug patent challenges be filed against ZEPBOUND (AUTOINJECTOR)?
Generic name: tirzepatide
NCE-1 Date: May 2026
ZEPBOUND (AUTOINJECTOR) is a drug marketed by Eli Lilly And Co. There are three patents protecting this drug.
This drug has one hundred and seventeen patent family members in forty-four countries.
The generic ingredient in ZEPBOUND (AUTOINJECTOR) is tirzepatide. Additional details are available on the tirzepatide profile page.
