37 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2019 - 2020
Loss of Exclusivity / End of Market Exclusivity Period dates
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Friedman, Yali, "37 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2019 - 2020" DrugPatentWatch.com thinkBiotech, 2019 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.
VIBERZI
Generic name: eluxadoline
NCE-1 Date: May 2019
This drug has one hundred and thirty-two patent family members in thirty-seven countries. There has been litigation on patents covering VIBERZI
See drug price trends for VIBERZI.
The generic ingredient in VIBERZI is eluxadoline. There are two drug master file entries for this API. Additional details are available on the eluxadoline profile page.
KENGREAL
Generic name: cangrelor
NCE-1 Date: June 2019
KENGREAL is a drug marketed by Chiesi Usa Inc. There are nine patents protecting this drug.
This drug has ninety-seven patent family members in forty-one countries.
See drug price trends for KENGREAL.
The generic ingredient in KENGREAL is cangrelor. There are three drug master file entries for this API. Additional details are available on the cangrelor profile page.
ORKAMBI
Generic name: ivacaftor; lumacaftor
NCE-1 Date: July 2019
ORKAMBI is a drug marketed by Vertex Pharms Inc. There are seventeen patents protecting this drug.
This drug has three hundred and twenty-three patent family members in thirty-four countries.
See drug price trends for ORKAMBI.
The generic ingredient in ORKAMBI is ivacaftor; lumacaftor. There are three drug master file entries for this API. Additional details are available on the ivacaftor; lumacaftor profile page.
ENTRESTO
Generic name: sacubitril; valsartan
NCE-1 Date: July 2019
This drug has ninety patent family members in thirty-seven countries.
See drug price trends for ENTRESTO.
The generic ingredient in ENTRESTO is sacubitril; valsartan. There are eleven drug master file entries for this API. Additional details are available on the sacubitril; valsartan profile page.
REXULTI
Generic name: brexpiprazole
NCE-1 Date: July 2019
This drug has thirty-two patent family members in twenty-seven countries.
See drug price trends for REXULTI.
The generic ingredient in REXULTI is brexpiprazole. There are eight drug master file entries for this API. Additional details are available on the brexpiprazole profile page.
DAKLINZA
Generic name: daclatasvir dihydrochloride
NCE-1 Date: July 2019
This drug has eighty-eight patent family members in thirty-one countries.
See drug price trends for DAKLINZA.
The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride profile page.
ODOMZO
Generic name: sonidegib phosphate
NCE-1 Date: July 2019
ODOMZO is a drug marketed by Sun Pharma Global. There are two patents protecting this drug.
This drug has one hundred and five patent family members in forty-seven countries.
See drug price trends for ODOMZO.
The generic ingredient in ODOMZO is sonidegib phosphate. There are two drug master file entries for this API. Additional details are available on the sonidegib phosphate profile page.
ADDYI
Generic name: flibanserin
NCE-1 Date: August 2019
ADDYI is a drug marketed by Sprout Pharms. There are four patents protecting this drug.
This drug has eighty-one patent family members in thirty-one countries.
See drug price trends for ADDYI.
The generic ingredient in ADDYI is flibanserin. Additional details are available on the flibanserin profile page.
VARUBI
Generic name: rolapitant hydrochloride
NCE-1 Date: September 2019
VARUBI is a drug marketed by Tersera Theraps Llc. There are nine patents protecting this drug.
This drug has one hundred and fifty-nine patent family members in thirty-five countries.
The generic ingredient in VARUBI is rolapitant hydrochloride. Additional details are available on the rolapitant hydrochloride profile page.
VISTOGARD
Generic name: uridine triacetate
NCE-1 Date: September 2019
VISTOGARD is a drug marketed by Wellstat Therap. There are two patents protecting this drug.
This drug has one hundred and seventy-five patent family members in twenty-one countries.
The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this API. Additional details are available on the uridine triacetate profile page.
XURIDEN
Generic name: uridine triacetate
NCE-1 Date: September 2019
XURIDEN is a drug marketed by Wellstat Therap. There is one patent protecting this drug.
This drug has one hundred and seventy-five patent family members in twenty-one countries.
The generic ingredient in XURIDEN is uridine triacetate. There are thirty-six drug master file entries for this API. Additional details are available on the uridine triacetate profile page.
VRAYLAR
Generic name: cariprazine hydrochloride
NCE-1 Date: September 2019
This drug has eighty-two patent family members in thirty-seven countries.
See drug price trends for VRAYLAR.
The generic ingredient in VRAYLAR is cariprazine hydrochloride. There are two drug master file entries for this API. Additional details are available on the cariprazine hydrochloride profile page.
LONSURF
Generic name: tipiracil hydrochloride; trifluridine
NCE-1 Date: September 2019
LONSURF is a drug marketed by Taiho Oncology. There are three patents protecting this drug.
This drug has fifty-five patent family members in twenty-six countries.
See drug price trends for LONSURF.
The generic ingredient in LONSURF is tipiracil hydrochloride; trifluridine. There are two drug master file entries for this API. Additional details are available on the tipiracil hydrochloride; trifluridine profile page.
RYZODEG 70/30
Generic name: insulin aspart; insulin degludec
NCE-1 Date: September 2019
RYZODEG 70/30 is a drug marketed by Novo. There are seventeen patents protecting this drug.
This drug has one hundred and sixty-nine patent family members in twenty-three countries. There has been litigation on patents covering RYZODEG 70/30
The generic ingredient in RYZODEG 70/30 is insulin aspart; insulin degludec. There are forty drug master file entries for this API. Additional details are available on the insulin aspart; insulin degludec profile page.
TRESIBA
Generic name: insulin degludec
NCE-1 Date: September 2019
TRESIBA is a drug marketed by Novo. There are sixteen patents protecting this drug.
This drug has one hundred and sixty-one patent family members in twenty-three countries. There has been litigation on patents covering TRESIBA
See drug price trends for TRESIBA.
The generic ingredient in TRESIBA is insulin degludec. There are forty drug master file entries for this API. Additional details are available on the insulin degludec profile page.
XULTOPHY 100/3.6
Generic name: insulin degludec; liraglutide
NCE-1 Date: September 2019
XULTOPHY 100/3.6 is a drug marketed by Novo. There are eighteen patents protecting this drug.
This drug has two hundred and eighty-three patent family members in twenty-seven countries. There has been litigation on patents covering XULTOPHY 100/3.6
The generic ingredient in XULTOPHY 100/3.6 is insulin degludec; liraglutide. There are forty drug master file entries for this API. Additional details are available on the insulin degludec; liraglutide profile page.
ARISTADA
Generic name: aripiprazole lauroxil
NCE-1 Date: October 2019
ARISTADA is a drug marketed by Alkermes Inc. There are eight patents protecting this drug.
This drug has eighty-six patent family members in twenty-six countries.
See drug price trends for ARISTADA.
The generic ingredient in ARISTADA is aripiprazole lauroxil. There are forty-nine drug master file entries for this API. Additional details are available on the aripiprazole lauroxil profile page.
ARISTADA INITIO KIT
Generic name: aripiprazole lauroxil
NCE-1 Date: October 2019
ARISTADA INITIO KIT is a drug marketed by Alkermes Inc. There are four patents protecting this drug.
This drug has forty-eight patent family members in twenty-four countries.
The generic ingredient in ARISTADA INITIO KIT is aripiprazole lauroxil. There are forty-nine drug master file entries for this API. Additional details are available on the aripiprazole lauroxil profile page.
VELTASSA
Generic name: patiromer sorbitex calcium
NCE-1 Date: October 2019
This drug has one hundred and fifty-three patent family members in twenty-three countries. There has been litigation on patents covering VELTASSA
See drug price trends for VELTASSA.
The generic ingredient in VELTASSA is patiromer sorbitex calcium. Additional details are available on the patiromer sorbitex calcium profile page.
YONDELIS
Generic name: trabectedin
NCE-1 Date: October 2019
YONDELIS is a drug marketed by Janssen Prods. There is one patent protecting this drug.
This drug has forty-two patent family members in thirty-five countries.
See drug price trends for YONDELIS.
The generic ingredient in YONDELIS is trabectedin. There are four drug master file entries for this API. Additional details are available on the trabectedin profile page.
DESCOVY
Generic name: emtricitabine; tenofovir alafenamide fumarate
NCE-1 Date: November 2019
This drug has three hundred and four patent family members in fifty-nine countries. There has been litigation on patents covering DESCOVY
See drug price trends for DESCOVY.
The generic ingredient in DESCOVY is emtricitabine; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this API. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.
GENVOYA
Generic name: cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
NCE-1 Date: November 2019
GENVOYA is a drug marketed by Gilead Sciences Inc. There are thirteen patents protecting this drug.
This drug has six hundred and forty-two patent family members in sixty countries. There has been litigation on patents covering GENVOYA
See drug price trends for GENVOYA.
The generic ingredient in GENVOYA is cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this API. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate profile page.
ODEFSEY
Generic name: emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
NCE-1 Date: November 2019
ODEFSEY is a drug marketed by Gilead Sciences Inc. There are eleven patents protecting this drug.
This drug has five hundred and twenty patent family members in sixty-one countries. There has been litigation on patents covering ODEFSEY
See drug price trends for ODEFSEY.
The generic ingredient in ODEFSEY is emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this API. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate profile page.
SYMTUZA
Generic name: cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate
NCE-1 Date: November 2019
This drug has six hundred and twenty-nine patent family members in fifty-nine countries. There has been litigation on patents covering SYMTUZA
See drug price trends for SYMTUZA.
The generic ingredient in SYMTUZA is cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this API. Additional details are available on the cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate profile page.
VEMLIDY
Generic name: tenofovir alafenamide fumarate
NCE-1 Date: November 2019
This drug has one hundred and twenty-eight patent family members in forty-nine countries. There has been litigation on patents covering VEMLIDY
See drug price trends for VEMLIDY.
The generic ingredient in VEMLIDY is tenofovir alafenamide fumarate. There are forty-two drug master file entries for this API. Additional details are available on the tenofovir alafenamide fumarate profile page.
COTELLIC
Generic name: cobimetinib fumarate
NCE-1 Date: November 2019
COTELLIC is a drug marketed by Genentech Inc. There are two patents protecting this drug.
This drug has fifty-two patent family members in thirty countries.
See drug price trends for COTELLIC.
The generic ingredient in COTELLIC is cobimetinib fumarate. Additional details are available on the cobimetinib fumarate profile page.
TAGRISSO
Generic name: osimertinib mesylate
NCE-1 Date: November 2019
TAGRISSO is a drug marketed by Astrazeneca Pharms. There are three patents protecting this drug.
This drug has one hundred and eleven patent family members in forty-one countries.
See drug price trends for TAGRISSO.
The generic ingredient in TAGRISSO is osimertinib mesylate. There are two drug master file entries for this API. Additional details are available on the osimertinib mesylate profile page.
NINLARO
Generic name: ixazomib citrate
NCE-1 Date: November 2019
NINLARO is a drug marketed by Millennium Pharms. There are nine patents protecting this drug.
This drug has two hundred and nine patent family members in forty-five countries.
See drug price trends for NINLARO.
The generic ingredient in NINLARO is ixazomib citrate. Additional details are available on the ixazomib citrate profile page.
ALECENSA
Generic name: alectinib hydrochloride
NCE-1 Date: December 2019
ALECENSA is a drug marketed by Hoffmann-la Roche. There are three patents protecting this drug.
This drug has eighty patent family members in thirty-seven countries.
See drug price trends for ALECENSA.
The generic ingredient in ALECENSA is alectinib hydrochloride. Additional details are available on the alectinib hydrochloride profile page.
BRIDION
Generic name: sugammadex sodium
NCE-1 Date: December 2019
BRIDION is a drug marketed by Organon Sub Merck. There are three patents protecting this drug.
This drug has fifty-five patent family members in thirty countries.
See drug price trends for BRIDION.
The generic ingredient in BRIDION is sugammadex sodium. There are two drug master file entries for this API. Additional details are available on the sugammadex sodium profile page.
UPTRAVI
Generic name: selexipag
NCE-1 Date: December 2019
UPTRAVI is a drug marketed by Actelion Pharms Ltd. There are four patents protecting this drug.
This drug has ninety-five patent family members in thirty-two countries. There has been litigation on patents covering UPTRAVI
See drug price trends for UPTRAVI.
The generic ingredient in UPTRAVI is selexipag. There are two drug master file entries for this API. Additional details are available on the selexipag profile page.
ZURAMPIC
Generic name: lesinurad
NCE-1 Date: December 2019
ZURAMPIC is a drug marketed by Ironwood Pharms Inc. There are nine patents protecting this drug.
This drug has one hundred and ninety patent family members in forty countries.
See drug price trends for ZURAMPIC.
The generic ingredient in ZURAMPIC is lesinurad. Additional details are available on the lesinurad profile page.
ZEPATIER
Generic name: elbasvir; grazoprevir
NCE-1 Date: January 2020
This drug has one hundred and one patent family members in forty-one countries.
See drug price trends for ZEPATIER.
The generic ingredient in ZEPATIER is elbasvir; grazoprevir. Additional details are available on the elbasvir; grazoprevir profile page.
DEFITELIO
Generic name: defibrotide sodium
NCE-1 Date: March 2020
DEFITELIO is a drug marketed by Jazz Pharms Inc.
This drug has one hundred and one patent family members in forty-one countries.
See drug price trends for DEFITELIO.
The generic ingredient in DEFITELIO is defibrotide sodium. Additional details are available on the defibrotide sodium profile page.
VENCLEXTA
Generic name: venetoclax
NCE-1 Date: April 2020
VENCLEXTA is a drug marketed by Abbvie Inc. There are two patents protecting this drug.
This drug has one hundred and eighteen patent family members in forty-one countries.
See drug price trends for VENCLEXTA.
The generic ingredient in VENCLEXTA is venetoclax. Additional details are available on the venetoclax profile page.
NUPLAZID
Generic name: pimavanserin tartrate
NCE-1 Date: April 2020
NUPLAZID is a drug marketed by Acadia Pharms Inc. There are fifteen patents protecting this drug.
This drug has one hundred and forty-two patent family members in twenty-seven countries.
See drug price trends for NUPLAZID.
The generic ingredient in NUPLAZID is pimavanserin tartrate. There are two drug master file entries for this API. Additional details are available on the pimavanserin tartrate profile page.
BRIVIACT
Generic name: brivaracetam
NCE-1 Date: May 2020
This drug has one hundred and forty-five patent family members in forty-one countries.
See drug price trends for BRIVIACT.
The generic ingredient in BRIVIACT is brivaracetam. Additional details are available on the brivaracetam profile page.
