56 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2023 - 2024
Loss of Exclusivity / End of Market Exclusivity Period dates
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Friedman, Yali, "56 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2023 - 2024" DrugPatentWatch.com thinkBiotech, 2023 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 SUNOSI?
Generic name: solriamfetol hydrochloride
NCE-1 Date: June 2023
This drug has forty-eight patent family members in twenty countries.
See drug price trends for SUNOSI.
The generic ingredient in SUNOSI is solriamfetol hydrochloride. Additional details are available on the solriamfetol hydrochloride profile page.
When can drug patent challenges be filed against ZULRESSO?
Generic name: brexanolone
NCE-1 Date: June 2023
ZULRESSO is a drug marketed by Sage Therap. There are eight patents protecting this drug.
This drug has one hundred and ten patent family members in thirty-one countries. There has been litigation on patents covering ZULRESSO
See drug price trends for ZULRESSO.
The generic ingredient in ZULRESSO is brexanolone. Additional details are available on the brexanolone profile page.
When can drug patent challenges be filed against VYLEESI (AUTOINJECTOR)?
Generic name: bremelanotide acetate
NCE-1 Date: June 2023
VYLEESI (AUTOINJECTOR) is a drug marketed by Palatin Technologies. There are four patents protecting this drug.
This drug has seventy-nine patent family members in twenty-five countries.
The generic ingredient in VYLEESI (AUTOINJECTOR) is bremelanotide acetate. Additional details are available on the bremelanotide acetate profile page.
When can drug patent challenges be filed against XPOVIO?
Generic name: selinexor
NCE-1 Date: July 2023
XPOVIO is a drug marketed by Karyopharm Theraps. There are six patents protecting this drug.
This drug has one hundred and sixteen patent family members in thirty-seven countries.
See drug price trends for XPOVIO.
The generic ingredient in XPOVIO is selinexor. Additional details are available on the selinexor profile page.
When can drug patent challenges be filed against RECARBRIO?
Generic name: cilastatin sodium; imipenem; relebactam
NCE-1 Date: July 2023
RECARBRIO is a drug marketed by Msd Merck Co. There is one patent protecting this drug.
This drug has sixty-five patent family members in thirty-seven countries.
See drug price trends for RECARBRIO.
The generic ingredient in RECARBRIO is cilastatin sodium; imipenem; relebactam. There are sixteen drug master file entries for this API. Additional details are available on the cilastatin sodium; imipenem; relebactam profile page.
When can drug patent challenges be filed against ACCRUFER?
Generic name: ferric maltol
NCE-1 Date: July 2023
This drug has fifty-one patent family members in nineteen countries.
See drug price trends for ACCRUFER.
The generic ingredient in ACCRUFER is ferric maltol. There are twenty drug master file entries for this API. Additional details are available on the ferric maltol profile page.
When can drug patent challenges be filed against NUBEQA?
Generic name: darolutamide
NCE-1 Date: July 2023
NUBEQA is a drug marketed by Bayer Healthcare. There are eight patents protecting this drug.
This drug has one hundred and twenty patent family members in thirty-six countries.
See drug price trends for NUBEQA.
The generic ingredient in NUBEQA is darolutamide. Additional details are available on the darolutamide profile page.
When can drug patent challenges be filed against TURALIO?
Generic name: pexidartinib hydrochloride
NCE-1 Date: August 2023
TURALIO is a drug marketed by Daiichi Sankyo Inc. There are twelve patents protecting this drug.
This drug has one hundred and twenty-seven patent family members in forty-one countries.
See drug price trends for TURALIO.
The generic ingredient in TURALIO is pexidartinib hydrochloride. Additional details are available on the pexidartinib hydrochloride profile page.
When can drug patent challenges be filed against PRETOMANID?
Generic name: pretomanid
NCE-1 Date: August 2023
PRETOMANID is a drug marketed by Mylan Ireland Ltd.
This drug has one hundred and twenty-seven patent family members in forty-one countries.
See drug price trends for PRETOMANID.
The generic ingredient in PRETOMANID is pretomanid. Additional details are available on the pretomanid profile page.
When can drug patent challenges be filed against WAKIX?
Generic name: pitolisant hydrochloride
NCE-1 Date: August 2023
WAKIX is a drug marketed by Harmony. There are three patents protecting this drug.
This drug has sixty-one patent family members in thirty-one countries.
See drug price trends for WAKIX.
The generic ingredient in WAKIX is pitolisant hydrochloride. Additional details are available on the pitolisant hydrochloride profile page.
When can drug patent challenges be filed against ROZLYTREK?
Generic name: entrectinib
NCE-1 Date: August 2023
ROZLYTREK is a drug marketed by Genentech Inc. There are fourteen patents protecting this drug.
This drug has one hundred and twenty-one patent family members in twenty-nine countries.
See drug price trends for ROZLYTREK.
The generic ingredient in ROZLYTREK is entrectinib. Additional details are available on the entrectinib profile page.
When can drug patent challenges be filed against INREBIC?
Generic name: fedratinib hydrochloride
NCE-1 Date: August 2023
INREBIC is a drug marketed by Impact. There are five patents protecting this drug.
This drug has one hundred and eight patent family members in thirty-nine countries.
See drug price trends for INREBIC.
The generic ingredient in INREBIC is fedratinib hydrochloride. Additional details are available on the fedratinib hydrochloride profile page.
When can drug patent challenges be filed against RINVOQ?
Generic name: upadacitinib
NCE-1 Date: August 2023
RINVOQ is a drug marketed by Abbvie Inc. There are seventeen patents protecting this drug.
This drug has one hundred and sixty-three patent family members in forty-one countries.
See drug price trends for RINVOQ.
The generic ingredient in RINVOQ is upadacitinib. Additional details are available on the upadacitinib profile page.
When can drug patent challenges be filed against XENLETA?
Generic name: lefamulin acetate
NCE-1 Date: August 2023
XENLETA is a drug marketed by Nabriva. There are three patents protecting this drug.
This drug has eighty-five patent family members in thirty-three countries. There has been litigation on patents covering XENLETA
See drug price trends for XENLETA.
The generic ingredient in XENLETA is lefamulin acetate. Additional details are available on the lefamulin acetate profile page.
When can drug patent challenges be filed against GALLIUM GA 68 DOTATOC?
Generic name: gallium ga-68 dotatoc
NCE-1 Date: August 2023
GALLIUM GA 68 DOTATOC is a drug marketed by Uihc Pet Imaging.
This drug has eighty-five patent family members in thirty-three countries.
The generic ingredient in GALLIUM GA 68 DOTATOC is gallium ga-68 dotatoc. There are sixteen drug master file entries for this API. Additional details are available on the gallium ga-68 dotatoc profile page.
When can drug patent challenges be filed against NOURIANZ?
Generic name: istradefylline
NCE-1 Date: August 2023
NOURIANZ is a drug marketed by Kyowa Kirin. There are four patents protecting this drug.
This drug has sixty-three patent family members in eighteen countries.
See drug price trends for NOURIANZ.
The generic ingredient in NOURIANZ is istradefylline. There is one drug master file entry for this API. Additional details are available on the istradefylline profile page.
When can drug patent challenges be filed against IBSRELA?
Generic name: tenapanor hydrochloride
NCE-1 Date: September 2023
This drug has thirty-seven patent family members in twenty-one countries.
See drug price trends for IBSRELA.
The generic ingredient in IBSRELA is tenapanor hydrochloride. Additional details are available on the tenapanor hydrochloride profile page.
When can drug patent challenges be filed against AKLIEF?
Generic name: trifarotene
NCE-1 Date: October 2023
This drug has sixty patent family members in twenty-eight countries.
See drug price trends for AKLIEF.
The generic ingredient in AKLIEF is trifarotene. There is one drug master file entry for this API. Additional details are available on the trifarotene profile page.
When can drug patent challenges be filed against SCENESSE?
Generic name: afamelanotide
NCE-1 Date: October 2023
SCENESSE is a drug marketed by Clivunel Inc. There are two patents protecting this drug.
This drug has thirty-four patent family members in eighteen countries.
See drug price trends for SCENESSE.
The generic ingredient in SCENESSE is afamelanotide. There is one drug master file entry for this API. Additional details are available on the afamelanotide profile page.
When can drug patent challenges be filed against FLUORODOPA F18?
Generic name: fluorodopa f-18
NCE-1 Date: October 2023
FLUORODOPA F18 is a drug marketed by Feinstein.
This drug has thirty-four patent family members in eighteen countries.
The generic ingredient in FLUORODOPA F18 is fluorodopa f-18. Additional details are available on the fluorodopa f-18 profile page.
When can drug patent challenges be filed against TRIKAFTA (COPACKAGED)?
Generic name: elexacaftor, ivacaftor, tezacaftor; ivacaftor
NCE-1 Date: October 2023
TRIKAFTA (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-five patents protecting this drug.
This drug has four hundred and fifty patent family members in forty-three countries.
The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. Additional details are available on the elexacaftor, ivacaftor, tezacaftor; ivacaftor profile page.
When can drug patent challenges be filed against EXEM FOAM KIT?
Generic name: air polymer-type a
NCE-1 Date: November 2023
EXEM FOAM KIT is a drug marketed by Giskit. There are three patents protecting this drug.
This drug has six patent family members in six countries.
The generic ingredient in EXEM FOAM KIT is air polymer-type a. There are thirty-seven drug master file entries for this API. Additional details are available on the air polymer-type a profile page.
When can drug patent challenges be filed against FETROJA?
Generic name: cefiderocol sulfate tosylate
NCE-1 Date: November 2023
FETROJA is a drug marketed by Shionogi Inc. There are three patents protecting this drug.
This drug has seventy-nine patent family members in thirty-six countries.
See drug price trends for FETROJA.
The generic ingredient in FETROJA is cefiderocol sulfate tosylate. Additional details are available on the cefiderocol sulfate tosylate profile page.
When can drug patent challenges be filed against BRUKINSA?
Generic name: zanubrutinib
NCE-1 Date: November 2023
BRUKINSA is a drug marketed by Beigene. There are four patents protecting this drug.
This drug has fifty patent family members in twenty-seven countries.
See drug price trends for BRUKINSA.
The generic ingredient in BRUKINSA is zanubrutinib. Additional details are available on the zanubrutinib profile page.
When can drug patent challenges be filed against GIVLAARI?
Generic name: givosiran sodium
NCE-1 Date: November 2023
GIVLAARI is a drug marketed by Alnylam Pharms Inc. There are fourteen patents protecting this drug.
This drug has four hundred and thirteen patent family members in forty-two countries.
See drug price trends for GIVLAARI.
The generic ingredient in GIVLAARI is givosiran sodium. Additional details are available on the givosiran sodium profile page.
When can drug patent challenges be filed against OXBRYTA?
Generic name: voxelotor
NCE-1 Date: November 2023
OXBRYTA is a drug marketed by Global Blood Theraps. There are ten patents protecting this drug.
This drug has two hundred and fifty-three patent family members in thirty-eight countries.
See drug price trends for OXBRYTA.
The generic ingredient in OXBRYTA is voxelotor. Additional details are available on the voxelotor profile page.
When can drug patent challenges be filed against VYONDYS 53?
Generic name: golodirsen
NCE-1 Date: December 2023
VYONDYS 53 is a drug marketed by Sarepta Theraps Inc. There are eight patents protecting this drug.
This drug has twenty-nine patent family members in thirteen countries. There has been litigation on patents covering VYONDYS 53
The generic ingredient in VYONDYS 53 is golodirsen. Additional details are available on the golodirsen profile page.
When can drug patent challenges be filed against TISSUEBLUE?
Generic name: brilliant blue g
NCE-1 Date: December 2023
TISSUEBLUE is a drug marketed by Dutch Ophthalmic.
This drug has twenty-nine patent family members in thirteen countries.
The generic ingredient in TISSUEBLUE is brilliant blue g. Additional details are available on the brilliant blue g profile page.
When can drug patent challenges be filed against CAPLYTA?
Generic name: lumateperone tosylate
NCE-1 Date: December 2023
This drug has one hundred and thirty-five patent family members in twenty countries. There has been litigation on patents covering CAPLYTA
See drug price trends for CAPLYTA.
The generic ingredient in CAPLYTA is lumateperone tosylate. Additional details are available on the lumateperone tosylate profile page.
When can drug patent challenges be filed against UBRELVY?
Generic name: ubrogepant
NCE-1 Date: December 2023
This drug has ninety-two patent family members in forty-one countries.
See drug price trends for UBRELVY.
The generic ingredient in UBRELVY is ubrogepant. Additional details are available on the ubrogepant profile page.
When can drug patent challenges be filed against AYVAKIT?
Generic name: avapritinib
NCE-1 Date: January 2024
AYVAKIT is a drug marketed by Blueprint Medicines. There are three patents protecting this drug.
This drug has forty-seven patent family members in thirty-one countries.
See drug price trends for AYVAKIT.
The generic ingredient in AYVAKIT is avapritinib. Additional details are available on the avapritinib profile page.
When can drug patent challenges be filed against TAZVERIK?
Generic name: tazemetostat hydrobromide
NCE-1 Date: January 2024
TAZVERIK is a drug marketed by Epizyme Inc. There are twenty-four patents protecting this drug.
This drug has three hundred and forty-three patent family members in thirty-eight countries.
See drug price trends for TAZVERIK.
The generic ingredient in TAZVERIK is tazemetostat hydrobromide. Additional details are available on the tazemetostat hydrobromide profile page.
When can drug patent challenges be filed against REYVOW?
Generic name: lasmiditan succinate
NCE-1 Date: January 2024
This drug has eighty-one patent family members in forty-two countries.
See drug price trends for REYVOW.
The generic ingredient in REYVOW is lasmiditan succinate. Additional details are available on the lasmiditan succinate profile page.
When can drug patent challenges be filed against PIZENSY?
Generic name: lactitol
NCE-1 Date: February 2024
PIZENSY is a drug marketed by Braintree Labs. There is one patent protecting this drug.
The generic ingredient in PIZENSY is lactitol. There are four drug master file entries for this API. Additional details are available on the lactitol profile page.
When can drug patent challenges be filed against NEXLETOL?
Generic name: bempedoic acid
NCE-1 Date: February 2024
This drug has twenty-three patent family members in thirteen countries.
See drug price trends for NEXLETOL.
The generic ingredient in NEXLETOL is bempedoic acid. Additional details are available on the bempedoic acid profile page.
When can drug patent challenges be filed against NEXLIZET?
Generic name: bempedoic acid; ezetimibe
NCE-1 Date: February 2024
This drug has forty-seven patent family members in twenty-two countries.
See drug price trends for NEXLIZET.
The generic ingredient in NEXLIZET is bempedoic acid; ezetimibe. Additional details are available on the bempedoic acid; ezetimibe profile page.
When can drug patent challenges be filed against BARHEMSYS?
Generic name: amisulpride
NCE-1 Date: February 2024
BARHEMSYS is a drug marketed by Acacia. There are five patents protecting this drug.
This drug has sixty-five patent family members in twenty-six countries.
See drug price trends for BARHEMSYS.
The generic ingredient in BARHEMSYS is amisulpride. There are four drug master file entries for this API. Additional details are available on the amisulpride profile page.
When can drug patent challenges be filed against NURTEC ODT?
Generic name: rimegepant sulfate
NCE-1 Date: February 2024
This drug has one hundred and three patent family members in thirty-five countries.
See drug price trends for NURTEC ODT.
The generic ingredient in NURTEC ODT is rimegepant sulfate. Additional details are available on the rimegepant sulfate profile page.
When can drug patent challenges be filed against ISTURISA?
Generic name: osilodrostat phosphate
NCE-1 Date: March 2024
ISTURISA is a drug marketed by Recordati Rare. There are six patents protecting this drug.
This drug has one hundred and thirty-four patent family members in forty-three countries.
See drug price trends for ISTURISA.
The generic ingredient in ISTURISA is osilodrostat phosphate. Additional details are available on the osilodrostat phosphate profile page.
When can drug patent challenges be filed against XCOPRI?
Generic name: cenobamate
NCE-1 Date: March 2024
This drug has twenty-three patent family members in nineteen countries.
See drug price trends for XCOPRI.
The generic ingredient in XCOPRI is cenobamate. Additional details are available on the cenobamate profile page.
When can drug patent challenges be filed against ZEPOSIA?
Generic name: ozanimod hydrochloride
NCE-1 Date: March 2024
ZEPOSIA is a drug marketed by Celgene Intl. There are four patents protecting this drug.
This drug has one hundred and fifty-two patent family members in thirty-one countries.
See drug price trends for ZEPOSIA.
The generic ingredient in ZEPOSIA is ozanimod hydrochloride. Additional details are available on the ozanimod hydrochloride profile page.
When can drug patent challenges be filed against DAYVIGO?
Generic name: lemborexant
NCE-1 Date: April 2024
This drug has fifty-three patent family members in thirty-two countries.
See drug price trends for DAYVIGO.
The generic ingredient in DAYVIGO is lemborexant. Additional details are available on the lemborexant profile page.
When can drug patent challenges be filed against KOSELUGO?
Generic name: selumetinib sulfate
NCE-1 Date: April 2024
KOSELUGO is a drug marketed by Astrazeneca. There are four patents protecting this drug.
This drug has one hundred and fifty-eight patent family members in thirty-nine countries.
See drug price trends for KOSELUGO.
The generic ingredient in KOSELUGO is selumetinib sulfate. Additional details are available on the selumetinib sulfate profile page.
When can drug patent challenges be filed against PEMAZYRE?
Generic name: pemigatinib
NCE-1 Date: April 2024
PEMAZYRE is a drug marketed by Incyte Corp. There are three patents protecting this drug.
This drug has one hundred and twenty-five patent family members in thirty-eight countries.
See drug price trends for PEMAZYRE.
The generic ingredient in PEMAZYRE is pemigatinib. Additional details are available on the pemigatinib profile page.
When can drug patent challenges be filed against TUKYSA?
Generic name: tucatinib
NCE-1 Date: April 2024
TUKYSA is a drug marketed by Seagen. There are five patents protecting this drug.
This drug has one hundred and ninety-five patent family members in forty-one countries.
See drug price trends for TUKYSA.
The generic ingredient in TUKYSA is tucatinib. Additional details are available on the tucatinib profile page.
When can drug patent challenges be filed against ONGENTYS?
Generic name: opicapone
NCE-1 Date: April 2024
This drug has one hundred and twenty-nine patent family members in thirty-one countries.
See drug price trends for ONGENTYS.
The generic ingredient in ONGENTYS is opicapone. There is one drug master file entry for this API. Additional details are available on the opicapone profile page.
When can drug patent challenges be filed against TABRECTA?
Generic name: capmatinib hydrochloride
NCE-1 Date: May 2024
TABRECTA is a drug marketed by Novartis Pharm. There are five patents protecting this drug.
This drug has one hundred and seventy patent family members in forty-three countries.
See drug price trends for TABRECTA.
The generic ingredient in TABRECTA is capmatinib hydrochloride. Additional details are available on the capmatinib hydrochloride profile page.
When can drug patent challenges be filed against RETEVMO?
Generic name: selpercatinib
NCE-1 Date: May 2024
RETEVMO is a drug marketed by Loxo Oncol Eli Lilly. There are five patents protecting this drug.
This drug has eighty-five patent family members in thirty-nine countries.
See drug price trends for RETEVMO.
The generic ingredient in RETEVMO is selpercatinib. Additional details are available on the selpercatinib profile page.
When can drug patent challenges be filed against QINLOCK?
Generic name: ripretinib
NCE-1 Date: May 2024
QINLOCK is a drug marketed by Deciphera Pharms. There are ten patents protecting this drug.
This drug has sixty-eight patent family members in thirteen countries.
See drug price trends for QINLOCK.
The generic ingredient in QINLOCK is ripretinib. Additional details are available on the ripretinib profile page.
When can drug patent challenges be filed against CERIANNA?
Generic name: fluoroestradiol f-18
NCE-1 Date: May 2024
CERIANNA is a drug marketed by Zionexa.
This drug has sixty-eight patent family members in thirteen countries.
The generic ingredient in CERIANNA is fluoroestradiol f-18. Additional details are available on the fluoroestradiol f-18 profile page.
When can drug patent challenges be filed against ARTESUNATE?
Generic name: artesunate
NCE-1 Date: May 2024
ARTESUNATE is a drug marketed by Amivas.
This drug has sixty-eight patent family members in thirteen countries.
See drug price trends for ARTESUNATE.
The generic ingredient in ARTESUNATE is artesunate. There are five drug master file entries for this API. Additional details are available on the artesunate profile page.
When can drug patent challenges be filed against TAUVID?
Generic name: flortaucipir f-18
NCE-1 Date: May 2024
TAUVID is a drug marketed by Avid Radiopharms Inc. There is one patent protecting this drug.
This drug has twenty-six patent family members in sixteen countries.
The generic ingredient in TAUVID is flortaucipir f-18. Additional details are available on the flortaucipir f-18 profile page.
When can drug patent challenges be filed against ZEPZELCA?
Generic name: lurbinectedin
NCE-1 Date: June 2024
ZEPZELCA is a drug marketed by Jazz. There is one patent protecting this drug.
This drug has thirty-two patent family members in twenty-three countries.
See drug price trends for ZEPZELCA.
The generic ingredient in ZEPZELCA is lurbinectedin. Additional details are available on the lurbinectedin profile page.
When can drug patent challenges be filed against DOJOLVI?
Generic name: triheptanoin
NCE-1 Date: June 2024
DOJOLVI is a drug marketed by Ultragenyx Pharm Inc. There are two patents protecting this drug.
This drug has eight patent family members in four countries.
The generic ingredient in DOJOLVI is triheptanoin. There is one drug master file entry for this API. Additional details are available on the triheptanoin profile page.
When can drug patent challenges be filed against RUKOBIA?
Generic name: fostemsavir tromethamine
NCE-1 Date: July 2024
RUKOBIA is a drug marketed by Viiv Hlthcare. There are three patents protecting this drug.
This drug has thirty-nine patent family members in thirty countries.
See drug price trends for RUKOBIA.
The generic ingredient in RUKOBIA is fostemsavir tromethamine. Additional details are available on the fostemsavir tromethamine profile page.
When can drug patent challenges be filed against INQOVI?
Generic name: cedazuridine; decitabine
NCE-1 Date: July 2024
INQOVI is a drug marketed by Otsuka. There are three patents protecting this drug.
This drug has forty-three patent family members in thirty-four countries.
See drug price trends for INQOVI.
The generic ingredient in INQOVI is cedazuridine; decitabine. Additional details are available on the cedazuridine; decitabine profile page.
