49 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2024 - 2025
Loss of Exclusivity / End of Market Exclusivity Period dates
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Friedman, Yali, "49 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2024 - 2025" DrugPatentWatch.com thinkBiotech, 2024 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 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-five patent family members in forty-four 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 one hundred and thirty-three patent family members in forty-one 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 twenty-four patents protecting this drug.
This drug has eighty-two patent family members in twenty 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 Ge Healthcare.
This drug has eighty-two patent family members in twenty 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 eighty-two patent family members in twenty 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.
See drug price trends for DOJOLVI.
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 fifty-one patent family members in thirty-nine 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.
When can drug patent challenges be filed against XEGLYZE?
Generic name: abametapir
NCE-1 Date: July 2024
XEGLYZE is a drug marketed by Hatchtech. There are five patents protecting this drug.
This drug has thirty-five patent family members in fifteen countries.
The generic ingredient in XEGLYZE is abametapir. Additional details are available on the abametapir profile page.
When can drug patent challenges be filed against LAMPIT?
Generic name: nifurtimox
NCE-1 Date: August 2024
LAMPIT is a drug marketed by Bayer Healthcare.
This drug has thirty-five patent family members in fifteen countries.
See drug price trends for LAMPIT.
The generic ingredient in LAMPIT is nifurtimox. Additional details are available on the nifurtimox profile page.
When can drug patent challenges be filed against EVRYSDI?
Generic name: risdiplam
NCE-1 Date: August 2024
EVRYSDI is a drug marketed by Genentech Inc. There are four patents protecting this drug.
This drug has one hundred and fourteen patent family members in thirty-nine countries.
See drug price trends for EVRYSDI.
The generic ingredient in EVRYSDI is risdiplam. Additional details are available on the risdiplam profile page.
When can drug patent challenges be filed against VILTEPSO?
Generic name: viltolarsen
NCE-1 Date: August 2024
VILTEPSO is a drug marketed by Nippon Shinyaku. There are two patents protecting this drug.
This drug has fifty-two patent family members in twenty countries.
See drug price trends for VILTEPSO.
The generic ingredient in VILTEPSO is viltolarsen. Additional details are available on the viltolarsen profile page.
When can drug patent challenges be filed against WINLEVI?
Generic name: clascoterone
NCE-1 Date: August 2024
This drug has eighty-nine patent family members in twenty-six countries.
See drug price trends for WINLEVI.
The generic ingredient in WINLEVI is clascoterone. Additional details are available on the clascoterone profile page.
When can drug patent challenges be filed against DETECTNET?
Generic name: copper cu-64 dotatate
NCE-1 Date: September 2024
DETECTNET is a drug marketed by Radiomedix. There are three patents protecting this drug.
This drug has eleven patent family members in six countries.
See drug price trends for DETECTNET.
The generic ingredient in DETECTNET is copper cu-64 dotatate. There are fifteen drug master file entries for this API. Additional details are available on the copper cu-64 dotatate profile page.
When can drug patent challenges be filed against GAVRETO?
Generic name: pralsetinib
NCE-1 Date: September 2024
GAVRETO is a drug marketed by Blueprint Medicines. There are three patents protecting this drug.
This drug has sixty-five patent family members in thirty-two countries.
See drug price trends for GAVRETO.
The generic ingredient in GAVRETO is pralsetinib. Additional details are available on the pralsetinib profile page.
When can drug patent challenges be filed against BYFAVO?
Generic name: remimazolam besylate
NCE-1 Date: October 2024
BYFAVO is a drug marketed by Acacia. There are eleven patents protecting this drug.
This drug has fifty-three patent family members in twenty-four countries.
See drug price trends for BYFAVO.
The generic ingredient in BYFAVO is remimazolam besylate. Additional details are available on the remimazolam besylate profile page.
When can drug patent challenges be filed against VEKLURY?
Generic name: remdesivir
NCE-1 Date: October 2024
VEKLURY is a drug marketed by Gilead Sciences Inc. There are thirteen patents protecting this drug.
This drug has three hundred and twenty-four patent family members in forty-seven countries.
The generic ingredient in VEKLURY is remdesivir. Additional details are available on the remdesivir profile page.
When can drug patent challenges be filed against OLINVYK?
Generic name: oliceridine
NCE-1 Date: October 2024
OLINVYK is a drug marketed by Trevena. There are four patents protecting this drug.
This drug has fifty-one patent family members in twenty-three countries.
See drug price trends for OLINVYK.
The generic ingredient in OLINVYK is oliceridine. Additional details are available on the oliceridine profile page.
When can drug patent challenges be filed against ZOKINVY?
Generic name: lonafarnib
NCE-1 Date: November 2024
ZOKINVY is a drug marketed by Eiger Biopharms. There are two patents protecting this drug.
This drug has nine patent family members in six countries.
See drug price trends for ZOKINVY.
The generic ingredient in ZOKINVY is lonafarnib. Additional details are available on the lonafarnib profile page.
When can drug patent challenges be filed against OXLUMO?
Generic name: lumasiran sodium
NCE-1 Date: November 2024
OXLUMO is a drug marketed by Alnylam Pharms Inc. There are fourteen patents protecting this drug.
This drug has one hundred and sixty-seven patent family members in forty-two countries.
See drug price trends for OXLUMO.
The generic ingredient in OXLUMO is lumasiran sodium. Additional details are available on the lumasiran sodium profile page.
When can drug patent challenges be filed against IMCIVREE?
Generic name: setmelanotide acetate
NCE-1 Date: November 2024
IMCIVREE is a drug marketed by Rhythm. There are three patents protecting this drug.
This drug has ninety-four patent family members in twenty-one countries.
See drug price trends for IMCIVREE.
The generic ingredient in IMCIVREE is setmelanotide acetate. Additional details are available on the setmelanotide acetate profile page.
When can drug patent challenges be filed against GALLIUM GA 68 GOZETOTIDE?
Generic name: gallium ga-68 gozetotide
NCE-1 Date: December 2024
GALLIUM GA 68 GOZETOTIDE is a drug marketed by Univ Ca Los Angeles and Univ Of Ca San Fran
This drug has ninety-four patent family members in twenty-one countries.
The generic ingredient in GALLIUM GA 68 GOZETOTIDE is gallium ga-68 gozetotide. There are sixteen drug master file entries for this API. Additional details are available on the gallium ga-68 gozetotide profile page.
When can drug patent challenges be filed against ORLADEYO?
Generic name: berotralstat hydrochloride
NCE-1 Date: December 2024
ORLADEYO is a drug marketed by Biocryst. There are eight patents protecting this drug.
This drug has seventy-nine patent family members in thirty-four countries.
See drug price trends for ORLADEYO.
The generic ingredient in ORLADEYO is berotralstat hydrochloride. Additional details are available on the berotralstat hydrochloride profile page.
When can drug patent challenges be filed against KLISYRI?
Generic name: tirbanibulin
NCE-1 Date: December 2024
KLISYRI is a drug marketed by Almirall. There are eight patents protecting this drug.
This drug has one hundred and six patent family members in twenty-six countries.
See drug price trends for KLISYRI.
The generic ingredient in KLISYRI is tirbanibulin. Additional details are available on the tirbanibulin profile page.
When can drug patent challenges be filed against MYFEMBREE?
Generic name: estradiol; norethindrone acetate; relugolix
NCE-1 Date: December 2024
This drug has one hundred and thirty-four patent family members in thirty-four countries.
See drug price trends for MYFEMBREE.
The generic ingredient in MYFEMBREE is estradiol; norethindrone acetate; relugolix. There are seventy-five drug master file entries for this API. Additional details are available on the estradiol; norethindrone acetate; relugolix profile page.
When can drug patent challenges be filed against ORGOVYX?
Generic name: relugolix
NCE-1 Date: December 2024
ORGOVYX is a drug marketed by Sumitomo Pharma. There are eight patents protecting this drug.
This drug has one hundred and fifty-nine patent family members in thirty-six countries.
See drug price trends for ORGOVYX.
The generic ingredient in ORGOVYX is relugolix. Additional details are available on the relugolix profile page.
When can drug patent challenges be filed against GEMTESA?
Generic name: vibegron
NCE-1 Date: December 2024
This drug has fifty-five patent family members in forty countries.
See drug price trends for GEMTESA.
The generic ingredient in GEMTESA is vibegron. Additional details are available on the vibegron profile page.
When can drug patent challenges be filed against VERQUVO?
Generic name: vericiguat
NCE-1 Date: January 2025
This drug has two hundred and ten patent family members in forty-nine countries.
See drug price trends for VERQUVO.
The generic ingredient in VERQUVO is vericiguat. Additional details are available on the vericiguat profile page.
When can drug patent challenges be filed against APRETUDE?
Generic name: cabotegravir
NCE-1 Date: January 2025
APRETUDE is a drug marketed by Viiv Hlthcare. There are three patents protecting this drug.
This drug has one hundred and fifty-seven patent family members in thirty-eight countries.
See drug price trends for APRETUDE.
The generic ingredient in APRETUDE is cabotegravir. Additional details are available on the cabotegravir profile page.
When can drug patent challenges be filed against CABENUVA KIT?
Generic name: cabotegravir; rilpivirine
NCE-1 Date: January 2025
CABENUVA KIT is a drug marketed by Viiv Hlthcare. There are five patents protecting this drug.
This drug has three hundred and ninety-two patent family members in fifty-one countries. There has been litigation on patents covering CABENUVA KIT
The generic ingredient in CABENUVA KIT is cabotegravir; rilpivirine. Additional details are available on the cabotegravir; rilpivirine profile page.
When can drug patent challenges be filed against VOCABRIA?
Generic name: cabotegravir sodium
NCE-1 Date: January 2025
VOCABRIA is a drug marketed by Viiv Hlthcare. There are two patents protecting this drug.
This drug has one hundred and twenty-five patent family members in thirty-three countries.
The generic ingredient in VOCABRIA is cabotegravir sodium. Additional details are available on the cabotegravir sodium profile page.
When can drug patent challenges be filed against LUPKYNIS?
Generic name: voclosporin
NCE-1 Date: January 2025
LUPKYNIS is a drug marketed by Aurinia. There are three patents protecting this drug.
This drug has one hundred and eighty-eight patent family members in thirty-eight countries.
See drug price trends for LUPKYNIS.
The generic ingredient in LUPKYNIS is voclosporin. There is one drug master file entry for this API. Additional details are available on the voclosporin profile page.
When can drug patent challenges be filed against TEPMETKO?
Generic name: tepotinib hydrochloride
NCE-1 Date: February 2025
TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug.
This drug has seventy-six patent family members in thirty-five countries.
See drug price trends for TEPMETKO.
The generic ingredient in TEPMETKO is tepotinib hydrochloride. Additional details are available on the tepotinib hydrochloride profile page.
When can drug patent challenges be filed against UKONIQ?
Generic name: umbralisib tosylate
NCE-1 Date: February 2025
UKONIQ is a drug marketed by Tg Theraps. There are eight patents protecting this drug.
This drug has sixty-eight patent family members in thirty-one countries.
The generic ingredient in UKONIQ is umbralisib tosylate. Additional details are available on the umbralisib tosylate profile page.
When can drug patent challenges be filed against COSELA?
Generic name: trilaciclib dihydrochloride
NCE-1 Date: February 2025
COSELA is a drug marketed by G1 Therap. There are twelve patents protecting this drug.
This drug has one hundred and thirty-five patent family members in twenty-seven countries.
See drug price trends for COSELA.
The generic ingredient in COSELA is trilaciclib dihydrochloride. Additional details are available on the trilaciclib dihydrochloride profile page.
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-seven 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 PEPAXTO?
Generic name: melphalan flufenamide hydrochloride
NCE-1 Date: February 2025
PEPAXTO is a drug marketed by Oncopeptides Ab. There are six patents protecting this drug.
This drug has one hundred and eight patent family members in thirty-one countries.
The generic ingredient in PEPAXTO is melphalan flufenamide hydrochloride. There are twelve drug master file entries for this API. Additional details are available on the melphalan flufenamide hydrochloride 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 Janssen Pharms. There are five patents protecting this drug.
This drug has one hundred and forty-one patent family members in forty countries.
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-three patent family members in twenty-four 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-three patent family members in twenty-four 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 five patents protecting this drug.
This drug has twenty-one patent family members in seven countries.
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 one hundred and fifty-seven patent family members in forty-four 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 seventy-one patent family members in twenty-eight 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 ten patents protecting this drug.
This drug has one hundred and sixty patent family members in twenty-four 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-two patent family members in twenty-five 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 five patents protecting this drug.
This drug has ninety-three patent family members in twenty-three 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.
