41 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, "41 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 MOTEGRITY?
Generic name: prucalopride succinate
NCE-1 Date: December 2022
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.
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 forty 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-nine patent family members in forty-two 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-nine patent family members in forty-two 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-nine patent family members in forty-two 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-nine patent family members in forty-two 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-eight 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-eight 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 four 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 nine 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
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 fourteen 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-six 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-six 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 seventeen 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 RINVOQ?
Generic name: upadacitinib
NCE-1 Date: August 2023
RINVOQ is a drug marketed by Abbvie Inc. There are sixteen patents protecting this drug.
This drug has one hundred and sixty-one 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 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 ninety-seven patent family members in thirty-six 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 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
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.
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.
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-three patents protecting this drug.
This drug has four hundred and forty-two 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 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 forty-nine 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 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 GIVLAARI?
Generic name: givosiran sodium
NCE-1 Date: November 2023
GIVLAARI is a drug marketed by Alnylam Pharms Inc. There are thirteen patents protecting this drug.
This drug has four hundred and seven 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 nine patents protecting this drug.
This drug has two hundred and forty-five patent family members in thirty-seven 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 twenty-seven 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 eighty-eight 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.
