45 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, "45 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 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 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 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 twelve patent family members in thirty-seven 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 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 four patents protecting this drug.
This drug has thirty-seven patent family members in twenty-three 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 thirty-six 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 seven patent family members in seven countries.
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 sixteen patents protecting this drug.
This drug has three hundred and thirteen patent family members in thirty-three 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 thirty-five patents protecting this drug.
This drug has one hundred and forty-two 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 forty-two 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 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 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 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-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-one patents protecting this drug.
This drug has one hundred and thirty-two 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-five 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 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 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 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-two 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 MOTEGRITY?
Generic name: prucalopride succinate
NCE-1 Date: December 2022
This drug has sixty-two patent family members in twenty-nine 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 sixty-two patent family members in twenty-nine 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-six 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-six 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-six 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-six 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-two 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-six patent family members in forty-seven 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 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 one 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 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 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.
