53 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2021 - 2022
Loss of Exclusivity / End of Market Exclusivity Period dates
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Friedman, Yali, "53 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2021 - 2022" DrugPatentWatch.com thinkBiotech, 2021 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 VERZENIO?
Generic name: abemaciclib
NCE-1 Date: September 2021
VERZENIO is a drug marketed by Eli Lilly And Co. There is one patent protecting this drug.
This drug has fifty patent family members in forty-four countries.
See drug price trends for VERZENIO.
The generic ingredient in VERZENIO is abemaciclib. Additional details are available on the abemaciclib profile page.
When can drug patent challenges be filed against CALQUENCE?
Generic name: acalabrutinib
NCE-1 Date: October 2021
CALQUENCE is a drug marketed by Astrazeneca. There are seven patents protecting this drug.
This drug has one hundred and twenty-nine patent family members in forty-six countries. There has been litigation on patents covering CALQUENCE
See drug price trends for CALQUENCE.
The generic ingredient in CALQUENCE is acalabrutinib. Additional details are available on the acalabrutinib profile page.
When can drug patent challenges be filed against PREVYMIS?
Generic name: letermovir
NCE-1 Date: November 2021
PREVYMIS is a drug marketed by Merck Sharp Dohme. There are three patents protecting this drug.
This drug has eighty-one patent family members in forty-five countries.
See drug price trends for PREVYMIS.
The generic ingredient in PREVYMIS is letermovir. Additional details are available on the letermovir profile page.
When can drug patent challenges be filed against RYBELSUS?
Generic name: semaglutide
NCE-1 Date: December 2021
This drug has one hundred and thirty-seven patent family members in twenty-eight countries.
See drug price trends for RYBELSUS.
The generic ingredient in RYBELSUS is semaglutide. Additional details are available on the semaglutide profile page.
When can drug patent challenges be filed against OZEMPIC?
Generic name: semaglutide
NCE-1 Date: December 2021
This drug has two hundred and thirty-seven patent family members in twenty-eight countries. There has been litigation on patents covering OZEMPIC
See drug price trends for OZEMPIC.
The generic ingredient in OZEMPIC is semaglutide. Additional details are available on the semaglutide profile page.
When can drug patent challenges be filed against WEGOVY?
Generic name: semaglutide
NCE-1 Date: December 2021
WEGOVY is a drug marketed by Novo. There are four patents protecting this drug.
This drug has eighty patent family members in thirty countries.
See drug price trends for WEGOVY.
The generic ingredient in WEGOVY is semaglutide. Additional details are available on the semaglutide profile page.
When can drug patent challenges be filed against XEPI?
Generic name: ozenoxacin
NCE-1 Date: December 2021
XEPI is a drug marketed by Ferrer Internacional. There are three patents protecting this drug.
This drug has fifty patent family members in twenty-five countries.
The generic ingredient in XEPI is ozenoxacin. There is one drug master file entry for this API. Additional details are available on the ozenoxacin profile page.
When can drug patent challenges be filed against GOPRELTO?
Generic name: cocaine hydrochloride
NCE-1 Date: December 2021
GOPRELTO is a drug marketed by Genus Lifesciences. There are eleven patents protecting this drug.There has been litigation on patents covering GOPRELTO
The generic ingredient in GOPRELTO is cocaine hydrochloride. There are three drug master file entries for this API. Additional details are available on the cocaine hydrochloride profile page.
When can drug patent challenges be filed against NUMBRINO?
Generic name: cocaine hydrochloride
NCE-1 Date: December 2021
NUMBRINO is a drug marketed by Cody Labs Inc.
See drug price trends for NUMBRINO.
The generic ingredient in NUMBRINO is cocaine hydrochloride. There are three drug master file entries for this API. Additional details are available on the cocaine hydrochloride profile page.
When can drug patent challenges be filed against RHOPRESSA?
Generic name: netarsudil mesylate
NCE-1 Date: December 2021
This drug has fifty-seven patent family members in nine countries.
See drug price trends for RHOPRESSA.
The generic ingredient in RHOPRESSA is netarsudil mesylate. Additional details are available on the netarsudil mesylate profile page.
When can drug patent challenges be filed against ROCKLATAN?
Generic name: latanoprost; netarsudil dimesylate
NCE-1 Date: December 2021
This drug has fifty-seven patent family members in nine countries.
See drug price trends for ROCKLATAN.
The generic ingredient in ROCKLATAN is latanoprost; netarsudil dimesylate. There are twenty drug master file entries for this API. Additional details are available on the latanoprost; netarsudil dimesylate profile page.
When can drug patent challenges be filed against SEGLUROMET?
Generic name: ertugliflozin; metformin hydrochloride
NCE-1 Date: December 2021
This drug has eighty-four patent family members in forty-eight countries.
See drug price trends for SEGLUROMET.
The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. Additional details are available on the ertugliflozin; metformin hydrochloride profile page.
When can drug patent challenges be filed against STEGLATRO?
Generic name: ertugliflozin
NCE-1 Date: December 2021
This drug has fifty-nine patent family members in forty-eight countries.
See drug price trends for STEGLATRO.
The generic ingredient in STEGLATRO is ertugliflozin. Additional details are available on the ertugliflozin profile page.
When can drug patent challenges be filed against STEGLUJAN?
Generic name: ertugliflozin; sitagliptin phosphate
NCE-1 Date: December 2021
This drug has two hundred and ten patent family members in fifty-four countries. There has been litigation on patents covering STEGLUJAN
See drug price trends for STEGLUJAN.
The generic ingredient in STEGLUJAN is ertugliflozin; sitagliptin phosphate. Additional details are available on the ertugliflozin; sitagliptin phosphate profile page.
When can drug patent challenges be filed against MACRILEN?
Generic name: macimorelin acetate
NCE-1 Date: December 2021
MACRILEN is a drug marketed by Novo. There are two patents protecting this drug.
This drug has seventy-three patent family members in thirty-one countries.
See drug price trends for MACRILEN.
The generic ingredient in MACRILEN is macimorelin acetate. Additional details are available on the macimorelin acetate profile page.
When can drug patent challenges be filed against GIAPREZA?
Generic name: angiotensin ii acetate
NCE-1 Date: December 2021
GIAPREZA is a drug marketed by La Jolla Pharma. There are eight patents protecting this drug.
This drug has twenty-seven patent family members in twenty countries.
See drug price trends for GIAPREZA.
The generic ingredient in GIAPREZA is angiotensin ii acetate. There are five drug master file entries for this API. Additional details are available on the angiotensin ii acetate profile page.
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 seventeen patent family members in eleven 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 four hundred and ninety-eight 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 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 sixty-four 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 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 three hundred and ninety-nine 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 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 thirty-three 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-five 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-five 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 eighteen 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-four patent family members in forty-two 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-four patent family members in forty-two 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-four 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 seven patents protecting this drug.
This drug has ninety-nine patent family members in thirty-five 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-one patents protecting this drug.
This drug has four hundred and fifty-one patent family members in thirty-four 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 Theraps Us. There are twenty-seven patents protecting this drug.
This drug has one hundred and thirty-six 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-six 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 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 eighty-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 four patents protecting this drug.
This drug has one hundred and forty-one patent family members in thirty-one 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 sixteen patents protecting this drug.
This drug has one hundred and four patent family members in twenty-two countries. There has been litigation on patents covering EPIDIOLEX
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-one 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.
