21 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2020 - 2021
Loss of Exclusivity / End of Market Exclusivity Period dates
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Friedman, Yali, "21 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2020 - 2021" DrugPatentWatch.com thinkBiotech, 2020 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 ZEPATIER?
Generic name: elbasvir; grazoprevir
NCE-1 Date: January 2020
This drug has one hundred and six patent family members in forty-three 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.
When can drug patent challenges be filed against 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 six patent family members in forty-three 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.
When can drug patent challenges be filed against VENCLEXTA?
Generic name: venetoclax
NCE-1 Date: April 2020
VENCLEXTA is a drug marketed by Abbvie Inc. There are three patents protecting this drug.
This drug has one hundred and forty patent family members in forty-two countries.
See drug price trends for VENCLEXTA.
The generic ingredient in VENCLEXTA is venetoclax. Additional details are available on the venetoclax profile page.
When can drug patent challenges be filed against NUPLAZID?
Generic name: pimavanserin tartrate
NCE-1 Date: April 2020
NUPLAZID is a drug marketed by Acadia Pharms Inc. There are sixteen patents protecting this drug.
This drug has one hundred and forty-five 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.
When can drug patent challenges be filed against 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.
When can drug patent challenges be filed against AXUMIN?
Generic name: fluciclovine f-18
NCE-1 Date: May 2020
AXUMIN is a drug marketed by Blue Earth. There are four patents protecting this drug.
This drug has thirty-nine patent family members in sixteen countries.
The generic ingredient in AXUMIN is fluciclovine f-18. Additional details are available on the fluciclovine f-18 profile page.
When can drug patent challenges be filed against OCALIVA?
Generic name: obeticholic acid
NCE-1 Date: May 2020
OCALIVA is a drug marketed by Intercept Pharms Inc. There are seven patents protecting this drug.
This drug has ninety-eight patent family members in thirty-one countries.
See drug price trends for OCALIVA.
The generic ingredient in OCALIVA is obeticholic acid. There is one drug master file entry for this API. Additional details are available on the obeticholic acid profile page.
When can drug patent challenges be filed against NETSPOT?
Generic name: gallium dotatate ga-68
NCE-1 Date: June 2020
NETSPOT is a drug marketed by Aaa Usa Inc. There is one patent protecting this drug.
This drug has twenty-six patent family members in nineteen countries.
The generic ingredient in NETSPOT is gallium dotatate ga-68. There are sixteen drug master file entries for this API. Additional details are available on the gallium dotatate ga-68 profile page.
When can drug patent challenges be filed against EPCLUSA?
Generic name: sofosbuvir; velpatasvir
NCE-1 Date: June 2020
This drug has four hundred and sixty-two patent family members in forty-seven countries. There has been litigation on patents covering EPCLUSA
See drug price trends for EPCLUSA.
The generic ingredient in EPCLUSA is sofosbuvir; velpatasvir. There are nine drug master file entries for this API. Additional details are available on the sofosbuvir; velpatasvir profile page.
When can drug patent challenges be filed against XIIDRA?
Generic name: lifitegrast
NCE-1 Date: July 2020
This drug has one hundred and six patent family members in twenty-one countries.
See drug price trends for XIIDRA.
The generic ingredient in XIIDRA is lifitegrast. Additional details are available on the lifitegrast profile page.
When can drug patent challenges be filed against SMOFLIPID 20%?
Generic name: fish oil; medium chain triglycerides; olive oil; soybean oil
NCE-1 Date: July 2020
SMOFLIPID 20% is a drug marketed by Fresenius Kabi Usa.
This drug has one hundred and six patent family members in twenty-one countries.
The generic ingredient in SMOFLIPID 20% is fish oil; medium chain triglycerides; olive oil; soybean oil. There are six drug master file entries for this API. Additional details are available on the fish oil; medium chain triglycerides; olive oil; soybean oil profile page.
When can drug patent challenges be filed against ADLYXIN?
Generic name: lixisenatide
NCE-1 Date: July 2020
ADLYXIN is a drug marketed by Sanofi-aventis Us. There are sixteen patents protecting this drug.
This drug has three hundred and forty-three patent family members in forty-three countries.
See drug price trends for ADLYXIN.
The generic ingredient in ADLYXIN is lixisenatide. Additional details are available on the lixisenatide profile page.
When can drug patent challenges be filed against SOLIQUA 100/33?
Generic name: insulin glargine; lixisenatide
NCE-1 Date: July 2020
SOLIQUA 100/33 is a drug marketed by Sanofi-aventis Us. There are twenty-six patents protecting this drug.
This drug has four hundred and seventy-one patent family members in fifty countries. There has been litigation on patents covering SOLIQUA 100/33
The generic ingredient in SOLIQUA 100/33 is insulin glargine; lixisenatide. There are forty drug master file entries for this API. Additional details are available on the insulin glargine; lixisenatide profile page.
When can drug patent challenges be filed against EXONDYS 51?
Generic name: eteplirsen
NCE-1 Date: September 2020
EXONDYS 51 is a drug marketed by Sarepta Theraps Inc. There are seven patents protecting this drug.
This drug has two hundred and five patent family members in twenty-four countries. There has been litigation on patents covering EXONDYS 51
The generic ingredient in EXONDYS 51 is eteplirsen. Additional details are available on the eteplirsen profile page.
When can drug patent challenges be filed against INTRAROSA?
Generic name: prasterone
NCE-1 Date: November 2020
This drug has fifty-three patent family members in twenty-eight countries.
See drug price trends for INTRAROSA.
The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries for this API. Additional details are available on the prasterone profile page.
When can drug patent challenges be filed against EUCRISA?
Generic name: crisaborole
NCE-1 Date: December 2020
This drug has one hundred and thirty-one patent family members in twenty-four countries.
See drug price trends for EUCRISA.
The generic ingredient in EUCRISA is crisaborole. There are three drug master file entries for this API. Additional details are available on the crisaborole profile page.
When can drug patent challenges be filed against RUBRACA?
Generic name: rucaparib camsylate
NCE-1 Date: December 2020
RUBRACA is a drug marketed by Clovis Oncology Inc. There are twelve patents protecting this drug.
This drug has two hundred and fifty-six patent family members in fifty-three countries.
See drug price trends for RUBRACA.
The generic ingredient in RUBRACA is rucaparib camsylate. Additional details are available on the rucaparib camsylate profile page.
When can drug patent challenges be filed against SPINRAZA?
Generic name: nusinersen sodium
NCE-1 Date: December 2020
SPINRAZA is a drug marketed by Biogen Idec. There are nine patents protecting this drug.
This drug has five hundred and seventy-five patent family members in thirty countries.
See drug price trends for SPINRAZA.
The generic ingredient in SPINRAZA is nusinersen sodium. Additional details are available on the nusinersen sodium profile page.
When can drug patent challenges be filed against TRULANCE?
Generic name: plecanatide
NCE-1 Date: January 2021
This drug has fifty-eight patent family members in fifteen countries. There has been litigation on patents covering TRULANCE
See drug price trends for TRULANCE.
The generic ingredient in TRULANCE is plecanatide. Additional details are available on the plecanatide profile page.
When can drug patent challenges be filed against PARSABIV?
Generic name: etelcalcetide
NCE-1 Date: February 2021
PARSABIV is a drug marketed by Kai Pharms Inc. There are six patents protecting this drug.
This drug has ninety patent family members in forty-one countries.
See drug price trends for PARSABIV.
The generic ingredient in PARSABIV is etelcalcetide. Additional details are available on the etelcalcetide profile page.
When can drug patent challenges be filed against EMFLAZA?
Generic name: deflazacort
NCE-1 Date: February 2021
EMFLAZA is a drug marketed by Ptc Therap.
This drug has ninety patent family members in forty-one countries.
See drug price trends for EMFLAZA.
The generic ingredient in EMFLAZA is deflazacort. There are three drug master file entries for this API. Additional details are available on the deflazacort profile page.
