25 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2020 - 2021
Loss of Exclusivity / End of Market Exclusivity Period dates
The content of this page is licensed under a Creative Commons Attribution 4.0 International License.
Friedman, Yali, "25 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2020 - 2021" DrugPatentWatch.com thinkBiotech, 2020 www.drugpatentwatch.com/p/nce-1/.
Media collateral
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 EPCLUSA?
Generic name: sofosbuvir; velpatasvir
NCE-1 Date: June 2020
This drug has four hundred and sixty-six 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 ten 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 ten 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 EXONDYS 51?
Generic name: eteplirsen
NCE-1 Date: September 2020
EXONDYS 51 is a drug marketed by Sarepta Theraps Inc. There are ten patents protecting this drug.
This drug has two hundred and six 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-two 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 sixty-eight 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-nine 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-nine 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.
When can drug patent challenges be filed against XERMELO?
Generic name: telotristat etiprate
NCE-1 Date: February 2021
XERMELO is a drug marketed by Lexicon Pharms Inc. There are five patents protecting this drug.
This drug has sixty-two patent family members in twenty-nine countries.
See drug price trends for XERMELO.
The generic ingredient in XERMELO is telotristat etiprate. Additional details are available on the telotristat etiprate profile page.
When can drug patent challenges be filed against KISQALI FEMARA CO-PACK (COPACKAGED)?
Generic name: letrozole; ribociclib succinate
NCE-1 Date: March 2021
KISQALI FEMARA CO-PACK (COPACKAGED) is a drug marketed by Novartis. There are seven patents protecting this drug.
This drug has one hundred and forty patent family members in fifty countries.
The generic ingredient in KISQALI FEMARA CO-PACK (COPACKAGED) is letrozole; ribociclib succinate. There are twenty-four drug master file entries for this API. Additional details are available on the letrozole; ribociclib succinate profile page.
When can drug patent challenges be filed against KISQALI?
Generic name: ribociclib succinate
NCE-1 Date: March 2021
KISQALI is a drug marketed by Novartis. There are seven patents protecting this drug.
This drug has one hundred and forty patent family members in fifty countries.
See drug price trends for KISQALI.
The generic ingredient in KISQALI is ribociclib succinate. Additional details are available on the ribociclib succinate profile page.
When can drug patent challenges be filed against XADAGO?
Generic name: safinamide mesylate
NCE-1 Date: March 2021
XADAGO is a drug marketed by Us Worldmeds Llc. There are three patents protecting this drug.
This drug has ninety-seven patent family members in thirty-one countries.
See drug price trends for XADAGO.
The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this API. Additional details are available on the safinamide mesylate profile page.
When can drug patent challenges be filed against SYMPROIC?
Generic name: naldemedine tosylate
NCE-1 Date: March 2021
This drug has sixty-two patent family members in twenty-four countries.
See drug price trends for SYMPROIC.
The generic ingredient in SYMPROIC is naldemedine tosylate. Additional details are available on the naldemedine tosylate profile page.
When can drug patent challenges be filed against ZEJULA?
Generic name: niraparib tosylate
NCE-1 Date: March 2021
ZEJULA is a drug marketed by Glaxosmithkline. There are five patents protecting this drug.
This drug has two hundred and forty-one patent family members in fifty countries.
See drug price trends for ZEJULA.
The generic ingredient in ZEJULA is niraparib tosylate. Additional details are available on the niraparib tosylate profile page.
When can drug patent challenges be filed against AUSTEDO?
Generic name: deutetrabenazine
NCE-1 Date: April 2021
This drug has forty-seven patent family members in twenty countries.
See drug price trends for AUSTEDO.
The generic ingredient in AUSTEDO is deutetrabenazine. Additional details are available on the deutetrabenazine profile page.
When can drug patent challenges be filed against INGREZZA?
Generic name: valbenazine tosylate
NCE-1 Date: April 2021
INGREZZA is a drug marketed by Neurocrine. There are three patents protecting this drug.
This drug has thirty-four patent family members in twenty countries.
See drug price trends for INGREZZA.
The generic ingredient in INGREZZA is valbenazine tosylate. Additional details are available on the valbenazine tosylate profile page.
When can drug patent challenges be filed against RYDAPT?
Generic name: midostaurin
NCE-1 Date: April 2021
RYDAPT is a drug marketed by Novartis. There are three patents protecting this drug.
This drug has sixty patent family members in twenty-seven countries. There has been litigation on patents covering RYDAPT
See drug price trends for RYDAPT.
The generic ingredient in RYDAPT is midostaurin. Additional details are available on the midostaurin profile page.
When can drug patent challenges be filed against TYMLOS?
Generic name: abaloparatide
NCE-1 Date: April 2021
This drug has thirty-seven patent family members in twenty-five countries.
See drug price trends for TYMLOS.
The generic ingredient in TYMLOS is abaloparatide. Additional details are available on the abaloparatide profile page.
When can drug patent challenges be filed against ALUNBRIG?
Generic name: brigatinib
NCE-1 Date: April 2021
ALUNBRIG is a drug marketed by Ariad. There are four patents protecting this drug.
This drug has sixty-two patent family members in thirty-three countries.
See drug price trends for ALUNBRIG.
The generic ingredient in ALUNBRIG is brigatinib. Additional details are available on the brigatinib profile page.
When can drug patent challenges be filed against RADICAVA?
Generic name: edaravone
NCE-1 Date: May 2021
RADICAVA is a drug marketed by Mitsubishi Tanabe. There is one patent protecting this drug.
This drug has seven patent family members in six countries.
See drug price trends for RADICAVA.
The generic ingredient in RADICAVA is edaravone. Additional details are available on the edaravone profile page.
When can drug patent challenges be filed against BAXDELA?
Generic name: delafloxacin meglumine
NCE-1 Date: June 2021
BAXDELA is a drug marketed by Melinta. There are thirteen patents protecting this drug.
This drug has seventy-eight patent family members in seventeen countries. There has been litigation on patents covering BAXDELA
See drug price trends for BAXDELA.
The generic ingredient in BAXDELA is delafloxacin meglumine. Additional details are available on the delafloxacin meglumine profile page.
When can drug patent challenges be filed against BEVYXXA?
Generic name: betrixaban
NCE-1 Date: June 2021
BEVYXXA is a drug marketed by Portola Pharms Inc. There are ten patents protecting this drug.
This drug has one hundred and twenty-seven patent family members in thirty-two countries.
See drug price trends for BEVYXXA.
The generic ingredient in BEVYXXA is betrixaban. Additional details are available on the betrixaban profile page.
