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 LUTATHERA?
Generic name: lutetium dotatate lu-177
NCE-1 Date: January 2022
LUTATHERA is a drug marketed by Aaa Usa Inc. There are two patents protecting this drug.
This drug has nineteen patent family members in twelve countries. There has been litigation on patents covering LUTATHERA
See drug price trends for LUTATHERA.
The generic ingredient in LUTATHERA is lutetium dotatate lu-177. There are four drug master file entries for this API. Additional details are available on the lutetium dotatate lu-177 profile page.
When can drug patent challenges be filed against BIKTARVY?
Generic name: bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate
NCE-1 Date: February 2022
This drug has five hundred and five patent family members in sixty-four countries. There has been litigation on patents covering BIKTARVY
See drug price trends for BIKTARVY.
The generic ingredient in BIKTARVY is bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate. Additional details are available on the bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate profile page.
When can drug patent challenges be filed against TRIKAFTA (COPACKAGED)?
Generic name: elexacaftor, ivacaftor, tezacaftor; ivacaftor
NCE-1 Date: February 2022
TRIKAFTA (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-one patents protecting this drug.
This drug has four hundred and eighteen patent family members in forty-two 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 SYMDEKO (COPACKAGED)?
Generic name: ivacaftor; ivacaftor, tezacaftor
NCE-1 Date: February 2022
SYMDEKO (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-one patents protecting this drug.
This drug has three hundred and eighty-nine patent family members in thirty-seven countries.
The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this API. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.
When can drug patent challenges be filed against ERLEADA?
Generic name: apalutamide
NCE-1 Date: February 2022
ERLEADA is a drug marketed by Janssen Biotech. There are nine patents protecting this drug.
This drug has two hundred and forty-four patent family members in forty-two countries. There has been litigation on patents covering ERLEADA
See drug price trends for ERLEADA.
The generic ingredient in ERLEADA is apalutamide. Additional details are available on the apalutamide profile page.
When can drug patent challenges be filed against TAVALISSE?
Generic name: fostamatinib disodium
NCE-1 Date: April 2022
TAVALISSE is a drug marketed by Rigel Pharms Inc. There are fourteen patents protecting this drug.
This drug has one hundred and thirteen patent family members in forty-three countries.
See drug price trends for TAVALISSE.
The generic ingredient in TAVALISSE is fostamatinib disodium. Additional details are available on the fostamatinib disodium profile page.
When can drug patent challenges be filed against AKYNZEO?
Generic name: fosnetupitant chloride hydrochloride; palonosetron hydrochloride
NCE-1 Date: April 2022
AKYNZEO is a drug marketed by Helsinn Hlthcare. There are eighteen patents protecting this drug.
This drug has two hundred and fifty-seven patent family members in sixty-eight countries.
See drug price trends for AKYNZEO.
The generic ingredient in AKYNZEO is fosnetupitant chloride hydrochloride; palonosetron hydrochloride. There is one drug master file entry for this API. Additional details are available on the fosnetupitant chloride hydrochloride; palonosetron hydrochloride profile page.
When can drug patent challenges be filed against LUCEMYRA?
Generic name: lofexidine hydrochloride
NCE-1 Date: May 2022
This drug has two hundred and fifty-seven patent family members in sixty-eight countries.
See drug price trends for LUCEMYRA.
The generic ingredient in LUCEMYRA is lofexidine hydrochloride. Additional details are available on the lofexidine hydrochloride profile page.
When can drug patent challenges be filed against LOKELMA?
Generic name: sodium zirconium cyclosilicate
NCE-1 Date: May 2022
This drug has one hundred and nineteen patent family members in thirty-four countries.
See drug price trends for LOKELMA.
The generic ingredient in LOKELMA is sodium zirconium cyclosilicate. There are one thousand four hundred and seventy-two drug master file entries for this API. Additional details are available on the sodium zirconium cyclosilicate profile page.
When can drug patent challenges be filed against DOPTELET?
Generic name: avatrombopag maleate
NCE-1 Date: May 2022
DOPTELET is a drug marketed by Akarx Inc. There are three patents protecting this drug.
This drug has twenty-one patent family members in fourteen countries.
See drug price trends for DOPTELET.
The generic ingredient in DOPTELET is avatrombopag maleate. Additional details are available on the avatrombopag maleate profile page.
When can drug patent challenges be filed against OLUMIANT?
Generic name: baricitinib
NCE-1 Date: May 2022
OLUMIANT is a drug marketed by Eli Lilly And Co. There are two patents protecting this drug.
This drug has fifty-six patent family members in forty-four countries.
See drug price trends for OLUMIANT.
The generic ingredient in OLUMIANT is baricitinib. Additional details are available on the baricitinib profile page.
When can drug patent challenges be filed against MOXIDECTIN?
Generic name: moxidectin
NCE-1 Date: June 2022
MOXIDECTIN is a drug marketed by Mdgh.
This drug has fifty-six patent family members in forty-four countries.
The generic ingredient in MOXIDECTIN is moxidectin. There is one drug master file entry for this API. Additional details are available on the moxidectin profile page.
When can drug patent challenges be filed against ZEMDRI?
Generic name: plazomicin sulfate
NCE-1 Date: June 2022
ZEMDRI is a drug marketed by Cipla Usa. There are four patents protecting this drug.
This drug has twenty-eight patent family members in twenty-one countries. There has been litigation on patents covering ZEMDRI
See drug price trends for ZEMDRI.
The generic ingredient in ZEMDRI is plazomicin sulfate. Additional details are available on the plazomicin sulfate profile page.
When can drug patent challenges be filed against BRAFTOVI?
Generic name: encorafenib
NCE-1 Date: June 2022
BRAFTOVI is a drug marketed by Array Biopharma Inc. There are thirteen patents protecting this drug.
This drug has one hundred and eighty-five patent family members in fifty-one countries.
See drug price trends for BRAFTOVI.
The generic ingredient in BRAFTOVI is encorafenib. Additional details are available on the encorafenib profile page.
When can drug patent challenges be filed against MEKTOVI?
Generic name: binimetinib
NCE-1 Date: June 2022
MEKTOVI is a drug marketed by Array Biopharma Inc. There are eleven patents protecting this drug.
This drug has two hundred and twenty-three patent family members in fifty-three countries.
The generic ingredient in MEKTOVI is binimetinib. Additional details are available on the binimetinib profile page.
When can drug patent challenges be filed against TPOXX?
Generic name: tecovirimat
NCE-1 Date: July 2022
TPOXX is a drug marketed by Siga Technologies. There are six patents protecting this drug.
This drug has seventy patent family members in twenty-one countries.
The generic ingredient in TPOXX is tecovirimat. Additional details are available on the tecovirimat profile page.
When can drug patent challenges be filed against TIBSOVO?
Generic name: ivosidenib
NCE-1 Date: July 2022
TIBSOVO is a drug marketed by Servier. There are eight patents protecting this drug.
This drug has one hundred and one patent family members in thirty-six countries.
See drug price trends for TIBSOVO.
The generic ingredient in TIBSOVO is ivosidenib. Additional details are available on the ivosidenib profile page.
When can drug patent challenges be filed against ARAKODA?
Generic name: tafenoquine succinate
NCE-1 Date: July 2022
ARAKODA is a drug marketed by 60 Degrees Pharms. There are two patents protecting this drug.
This drug has eight patent family members in seven countries.
See drug price trends for ARAKODA.
The generic ingredient in ARAKODA is tafenoquine succinate. Additional details are available on the tafenoquine succinate profile page.
When can drug patent challenges be filed against KRINTAFEL?
Generic name: tafenoquine succinate
NCE-1 Date: July 2022
KRINTAFEL is a drug marketed by Glaxosmithkline.
This drug has eight patent family members in seven countries.
See drug price trends for KRINTAFEL.
The generic ingredient in KRINTAFEL is tafenoquine succinate. Additional details are available on the tafenoquine succinate profile page.
When can drug patent challenges be filed against ORIAHNN (COPACKAGED)?
Generic name: elagolix sodium,estradiol,norethindrone acetate; elagolix sodium
NCE-1 Date: July 2022
ORIAHNN (COPACKAGED) is a drug marketed by Abbvie Inc. There are seven patents protecting this drug.
This drug has fifty-five patent family members in twenty-four countries.
The generic ingredient in ORIAHNN (COPACKAGED) is elagolix sodium,estradiol,norethindrone acetate; elagolix sodium. Additional details are available on the elagolix sodium,estradiol,norethindrone acetate; elagolix sodium profile page.
When can drug patent challenges be filed against ORILISSA?
Generic name: elagolix sodium
NCE-1 Date: July 2022
This drug has fifty-four patent family members in twenty-four countries.
See drug price trends for ORILISSA.
The generic ingredient in ORILISSA is elagolix sodium. Additional details are available on the elagolix sodium profile page.
When can drug patent challenges be filed against OMEGAVEN?
Generic name: fish oil triglycerides
NCE-1 Date: July 2022
OMEGAVEN is a drug marketed by Fresenius Kabi Usa. There are three patents protecting this drug.
This drug has five patent family members in four countries. There has been litigation on patents covering OMEGAVEN
See drug price trends for OMEGAVEN.
The generic ingredient in OMEGAVEN is fish oil triglycerides. There are six drug master file entries for this API. Additional details are available on the fish oil triglycerides profile page.
When can drug patent challenges be filed against MULPLETA?
Generic name: lusutrombopag
NCE-1 Date: July 2022
MULPLETA is a drug marketed by Shionogi Inc. There are four patents protecting this drug.
This drug has fifty-four patent family members in nineteen countries.
See drug price trends for MULPLETA.
The generic ingredient in MULPLETA is lusutrombopag. Additional details are available on the lusutrombopag profile page.
When can drug patent challenges be filed against ANNOVERA?
Generic name: ethinyl estradiol; segesterone acetate
NCE-1 Date: August 2022
ANNOVERA is a drug marketed by Therapeuticsmd Inc. There are six patents protecting this drug.
This drug has one patent family member in one country.
See drug price trends for ANNOVERA.
The generic ingredient in ANNOVERA is ethinyl estradiol; segesterone acetate. There are twenty-six drug master file entries for this API. Additional details are available on the ethinyl estradiol; segesterone acetate profile page.
When can drug patent challenges be filed against ONPATTRO?
Generic name: patisiran sodium
NCE-1 Date: August 2022
ONPATTRO is a drug marketed by Alnylam Pharms Inc. There are twenty-four patents protecting this drug.
This drug has four hundred and sixty-four patent family members in thirty-five countries. There has been litigation on patents covering ONPATTRO
See drug price trends for ONPATTRO.
The generic ingredient in ONPATTRO is patisiran sodium. Additional details are available on the patisiran sodium profile page.
When can drug patent challenges be filed against GALAFOLD?
Generic name: migalastat hydrochloride
NCE-1 Date: August 2022
GALAFOLD is a drug marketed by Amicus Therap Us. There are twenty-seven patents protecting this drug.
This drug has one hundred and thirty-eight patent family members in twenty-seven countries.
The generic ingredient in GALAFOLD is migalastat hydrochloride. Additional details are available on the migalastat hydrochloride profile page.
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.
This drug has one hundred and thirty-eight patent family members in twenty-seven countries.
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 two patents protecting this drug.
This drug has seventy patent family members in thirty 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 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 eighty-six 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 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 COPIKTRA?
Generic name: duvelisib
NCE-1 Date: September 2022
COPIKTRA is a drug marketed by Secura. There are four patents protecting this drug.
This drug has one hundred and forty-three patent family members in thirty-two 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 two patents protecting this drug.
This drug has fifty-five patent family members in forty-five 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 patents protecting this drug.
This drug has one hundred and eight patent family members in twenty-two 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 eleven patents protecting this drug.
This drug has two hundred and thirty-four 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 fifty-one 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 three patents protecting this drug.
This drug has eighty-one 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 three patents protecting this drug.
This drug has eighty-four patent family members in forty-seven 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 seventy-six patent family members in forty-seven 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-one 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 two 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.
