46 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2022 - 2023
Loss of Exclusivity / End of Market Exclusivity Period dates
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Friedman, Yali, "46 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2022 - 2023" DrugPatentWatch.com thinkBiotech, 2022 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 DIACOMIT?
Generic name: stiripentol
NCE-1 Date: August 2022
DIACOMIT is a drug marketed by Biocodex Sa.
See drug price trends for DIACOMIT.
The generic ingredient in DIACOMIT is stiripentol. Additional details are available on the stiripentol profile page.
When can drug patent challenges be filed against XERAVA?
Generic name: eravacycline dihydrochloride
NCE-1 Date: August 2022
XERAVA is a drug marketed by Tetraphase Pharms. There are three patents protecting this drug.
This drug has seventy-eight patent family members in thirty-two countries.
See drug price trends for XERAVA.
The generic ingredient in XERAVA is eravacycline dihydrochloride. Additional details are available on the eravacycline dihydrochloride profile page.
When can drug patent challenges be filed against PIFELTRO?
Generic name: doravirine
NCE-1 Date: August 2022
This drug has sixty-nine patent family members in forty-three countries.
See drug price trends for PIFELTRO.
The generic ingredient in PIFELTRO is doravirine. Additional details are available on the doravirine profile page.
When can drug patent challenges be filed against DELSTRIGO?
Generic name: doravirine; lamivudine; tenofovir disoproxil fumarate
NCE-1 Date: August 2022
DELSTRIGO is a drug marketed by Msd Merck Co. There are three patents protecting this drug.
This drug has ninety-one patent family members in forty-four countries.
The generic ingredient in DELSTRIGO is doravirine; lamivudine; tenofovir disoproxil fumarate. Additional details are available on the doravirine; lamivudine; tenofovir disoproxil fumarate profile page.
When can drug patent challenges be filed against COPIKTRA?
Generic name: duvelisib
NCE-1 Date: September 2022
COPIKTRA is a drug marketed by Secura. There are five patents protecting this drug.
This drug has one hundred and forty-seven patent family members in thirty-four countries.
The generic ingredient in COPIKTRA is duvelisib. Additional details are available on the duvelisib profile page.
When can drug patent challenges be filed against VIZIMPRO?
Generic name: dacomitinib
NCE-1 Date: September 2022
VIZIMPRO is a drug marketed by Pfizer. There are four patents protecting this drug.
This drug has ninety-one patent family members in forty-seven countries.
See drug price trends for VIZIMPRO.
The generic ingredient in VIZIMPRO is dacomitinib. Additional details are available on the dacomitinib profile page.
When can drug patent challenges be filed against EPIDIOLEX?
Generic name: cannabidiol
NCE-1 Date: September 2022
EPIDIOLEX is a drug marketed by Gw Res Ltd. There are twenty-two patents protecting this drug.
This drug has one hundred and thirty-four patent family members in twenty-five countries.
See drug price trends for EPIDIOLEX.
The generic ingredient in EPIDIOLEX is cannabidiol. There are nine drug master file entries for this API. Additional details are available on the cannabidiol profile page.
When can drug patent challenges be filed against SEYSARA?
Generic name: sarecycline hydrochloride
NCE-1 Date: October 2022
SEYSARA is a drug marketed by Almirall. There are four patents protecting this drug.
This drug has sixty-seven patent family members in twenty countries.
See drug price trends for SEYSARA.
The generic ingredient in SEYSARA is sarecycline hydrochloride. Additional details are available on the sarecycline hydrochloride profile page.
When can drug patent challenges be filed against NUZYRA?
Generic name: omadacycline tosylate
NCE-1 Date: October 2022
NUZYRA is a drug marketed by Paratek Pharms Inc. There are ten patents protecting this drug.
This drug has two hundred and thirty-six patent family members in forty countries.
See drug price trends for NUZYRA.
The generic ingredient in NUZYRA is omadacycline tosylate. Additional details are available on the omadacycline tosylate profile page.
When can drug patent challenges be filed against TEGSEDI?
Generic name: inotersen sodium
NCE-1 Date: October 2022
TEGSEDI is a drug marketed by Akcea Theraps. There are six patents protecting this drug.
This drug has five hundred and thirty-two patent family members in thirty countries.
See drug price trends for TEGSEDI.
The generic ingredient in TEGSEDI is inotersen sodium. Additional details are available on the inotersen sodium profile page.
When can drug patent challenges be filed against TALZENNA?
Generic name: talazoparib tosylate
NCE-1 Date: October 2022
TALZENNA is a drug marketed by Pfizer. There are five patents protecting this drug.
This drug has ninety patent family members in thirty countries.
See drug price trends for TALZENNA.
The generic ingredient in TALZENNA is talazoparib tosylate. Additional details are available on the talazoparib tosylate profile page.
When can drug patent challenges be filed against XOFLUZA?
Generic name: baloxavir marboxil
NCE-1 Date: October 2022
This drug has one hundred and seventy patent family members in thirty-six countries.
See drug price trends for XOFLUZA.
The generic ingredient in XOFLUZA is baloxavir marboxil. Additional details are available on the baloxavir marboxil profile page.
When can drug patent challenges be filed against LORBRENA?
Generic name: lorlatinib
NCE-1 Date: November 2022
LORBRENA is a drug marketed by Pfizer. There are four patents protecting this drug.
This drug has ninety-four patent family members in forty-seven countries.
See drug price trends for LORBRENA.
The generic ingredient in LORBRENA is lorlatinib. Additional details are available on the lorlatinib profile page.
When can drug patent challenges be filed against YUPELRI?
Generic name: revefenacin
NCE-1 Date: November 2022
This drug has seventy-one patent family members in thirty-one countries.
See drug price trends for YUPELRI.
The generic ingredient in YUPELRI is revefenacin. Additional details are available on the revefenacin profile page.
When can drug patent challenges be filed against DAURISMO?
Generic name: glasdegib maleate
NCE-1 Date: November 2022
DAURISMO is a drug marketed by Pfizer. There are four patents protecting this drug.
This drug has eighty-six patent family members in forty-eight countries.
See drug price trends for DAURISMO.
The generic ingredient in DAURISMO is glasdegib maleate. Additional details are available on the glasdegib maleate profile page.
When can drug patent challenges be filed against VITRAKVI?
Generic name: larotrectinib sulfate
NCE-1 Date: November 2022
VITRAKVI is a drug marketed by Bayer Hlthcare and Bayer HealthcareThere are sixteen patents protecting this drug.
This drug has one hundred and ninety-three patent family members in forty-eight countries.
See drug price trends for VITRAKVI.
The generic ingredient in VITRAKVI is larotrectinib sulfate. Additional details are available on the larotrectinib sulfate profile page.
When can drug patent challenges be filed against XOSPATA?
Generic name: gilteritinib fumarate
NCE-1 Date: November 2022
XOSPATA is a drug marketed by Astellas. There are three patents protecting this drug.
This drug has sixty-three patent family members in twenty-nine countries.
See drug price trends for XOSPATA.
The generic ingredient in XOSPATA is gilteritinib fumarate. Additional details are available on the gilteritinib fumarate profile page.
When can drug patent challenges be filed against FIRDAPSE?
Generic name: amifampridine phosphate
NCE-1 Date: November 2022
FIRDAPSE is a drug marketed by Catalyst Pharms. There are five patents protecting this drug.
This drug has two patent family members in two countries.
See drug price trends for FIRDAPSE.
The generic ingredient in FIRDAPSE is amifampridine phosphate. Additional details are available on the amifampridine phosphate profile page.
When can drug patent challenges be filed against MOTEGRITY?
Generic name: prucalopride succinate
NCE-1 Date: December 2022
This drug has two patent family members in two countries.
See drug price trends for MOTEGRITY.
The generic ingredient in MOTEGRITY is prucalopride succinate. Additional details are available on the prucalopride succinate profile page.
When can drug patent challenges be filed against EGATEN?
Generic name: triclabendazole
NCE-1 Date: February 2023
EGATEN is a drug marketed by Novartis.
This drug has two patent family members in two countries.
The generic ingredient in EGATEN is triclabendazole. There is one drug master file entry for this API. Additional details are available on the triclabendazole profile page.
When can drug patent challenges be filed against MAYZENT?
Generic name: siponimod fumaric acid
NCE-1 Date: March 2023
MAYZENT is a drug marketed by Novartis. There are two patents protecting this drug.
This drug has one hundred and thirty-eight patent family members in thirty-nine countries.
See drug price trends for MAYZENT.
The generic ingredient in MAYZENT is siponimod fumaric acid. Additional details are available on the siponimod fumaric acid profile page.
When can drug patent challenges be filed against BALVERSA?
Generic name: erdafitinib
NCE-1 Date: April 2023
BALVERSA is a drug marketed by Janssen Biotech. There are five patents protecting this drug.
This drug has one hundred and sixty-seven patent family members in forty-one countries.
See drug price trends for BALVERSA.
The generic ingredient in BALVERSA is erdafitinib. Additional details are available on the erdafitinib profile page.
When can drug patent challenges be filed against MULTRYS?
Generic name: cupric sulfate; manganese sulfate; selenious acid; zinc sulfate
NCE-1 Date: April 2023
MULTRYS is a drug marketed by Am Regent.
This drug has one hundred and sixty-seven patent family members in forty-one countries.
The generic ingredient in MULTRYS is cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. Additional details are available on the cupric sulfate; manganese sulfate; selenious acid; zinc sulfate profile page.
When can drug patent challenges be filed against SELENIOUS ACID?
Generic name: selenious acid
NCE-1 Date: April 2023
SELENIOUS ACID is a drug marketed by Am Regent.
This drug has one hundred and sixty-seven patent family members in forty-one countries.
The generic ingredient in SELENIOUS ACID is selenious acid. Additional details are available on the selenious acid profile page.
When can drug patent challenges be filed against TRALEMENT?
Generic name: cupric sulfate; manganese sulfate; selenious acid; zinc sulfate
NCE-1 Date: April 2023
TRALEMENT is a drug marketed by Am Regent.
This drug has one hundred and sixty-seven patent family members in forty-one countries.
See drug price trends for TRALEMENT.
The generic ingredient in TRALEMENT is cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. Additional details are available on the cupric sulfate; manganese sulfate; selenious acid; zinc sulfate profile page.
When can drug patent challenges be filed against VYNDAMAX?
Generic name: tafamidis
NCE-1 Date: May 2023
VYNDAMAX is a drug marketed by Foldrx Pharms. There are three patents protecting this drug.
This drug has sixty-three patent family members in twenty-eight countries.
See drug price trends for VYNDAMAX.
The generic ingredient in VYNDAMAX is tafamidis. Additional details are available on the tafamidis profile page.
When can drug patent challenges be filed against VYNDAQEL?
Generic name: tafamidis meglumine
NCE-1 Date: May 2023
VYNDAQEL is a drug marketed by Foldrx Pharms. There are four patents protecting this drug.
This drug has thirty-five patent family members in seventeen countries.
See drug price trends for VYNDAQEL.
The generic ingredient in VYNDAQEL is tafamidis meglumine. Additional details are available on the tafamidis meglumine profile page.
When can drug patent challenges be filed against PIQRAY?
Generic name: alpelisib
NCE-1 Date: May 2023
PIQRAY is a drug marketed by Novartis. There are two patents protecting this drug.
This drug has fifty-seven patent family members in forty-eight countries.
See drug price trends for PIQRAY.
The generic ingredient in PIQRAY is alpelisib. Additional details are available on the alpelisib profile page.
When can drug patent challenges be filed against VIJOICE?
Generic name: alpelisib
NCE-1 Date: May 2023
VIJOICE is a drug marketed by Novartis. There are two patents protecting this drug.
This drug has fifty-seven patent family members in forty-eight countries.
The generic ingredient in VIJOICE is alpelisib. Additional details are available on the alpelisib profile page.
When can drug patent challenges be filed against SUNOSI?
Generic name: solriamfetol hydrochloride
NCE-1 Date: June 2023
This drug has forty-two patent family members in nineteen 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 two patent family members in twenty-nine 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 seven patent family members in thirty-six 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-four patent family members in thirty-six 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
ACCRUFER is a drug marketed by Shield Tx. There are three patents protecting this drug.
This drug has fifty patent family members in nineteen countries.
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 eleven 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-four 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-four 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 fourteen 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 four patents protecting this drug.
This drug has eighty-four patent family members in thirty-five 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 fifteen patents protecting this drug.
This drug has one hundred and fifty-nine 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-four 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 DOTATOC GA 68?
Generic name: gallium dotatoc ga-68
NCE-1 Date: August 2023
GALLIUM DOTATOC GA 68 is a drug marketed by Uihc Pet Imaging.
This drug has eighty-four patent family members in thirty-three countries.
The generic ingredient in GALLIUM DOTATOC GA 68 is gallium dotatoc ga-68. There are sixteen drug master file entries for this API. Additional details are available on the gallium dotatoc ga-68 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
IBSRELA is a drug marketed by Ardelyx Inc. There are four patents protecting this drug.
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.
