39 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2021 - 2022
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, "39 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2021 - 2022" DrugPatentWatch.com thinkBiotech, 2021 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 KISQALI?
Generic name: ribociclib succinate
NCE-1 Date: March 2021
KISQALI is a drug marketed by Novartis. There are eight patents protecting this drug.
This drug has one hundred and sixty-six patent family members in fifty-one 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 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 eight patents protecting this drug.
This drug has one hundred and sixty-six patent family members in fifty-one 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 XADAGO?
Generic name: safinamide mesylate
NCE-1 Date: March 2021
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-three patent family members in twenty-five 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 fifty-two 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 eight patents protecting this drug.
This drug has eighty-four patent family members in twenty-one 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 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 seventy-five patent family members in thirty-five 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 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-one 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-nine 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 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 eighty-six patent family members in twenty-one 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.
When can drug patent challenges be filed against NERLYNX?
Generic name: neratinib maleate
NCE-1 Date: July 2021
NERLYNX is a drug marketed by Puma Biotech. There are eight patents protecting this drug.
This drug has one hundred and twenty-two patent family members in twenty-nine countries.
See drug price trends for NERLYNX.
The generic ingredient in NERLYNX is neratinib maleate. Additional details are available on the neratinib maleate profile page.
When can drug patent challenges be filed against VOSEVI?
Generic name: sofosbuvir; velpatasvir; voxilaprevir
NCE-1 Date: July 2021
VOSEVI is a drug marketed by Gilead Sciences Inc. There are fifteen patents protecting this drug.
This drug has five hundred and forty-three patent family members in forty-eight countries. There has been litigation on patents covering VOSEVI
See drug price trends for VOSEVI.
The generic ingredient in VOSEVI is sofosbuvir; velpatasvir; voxilaprevir. There are nine drug master file entries for this API. Additional details are available on the sofosbuvir; velpatasvir; voxilaprevir profile page.
When can drug patent challenges be filed against IDHIFA?
Generic name: enasidenib mesylate
NCE-1 Date: August 2021
IDHIFA is a drug marketed by Celgene Corp. There are six patents protecting this drug.
This drug has ninety-seven patent family members in thirty-seven countries.
See drug price trends for IDHIFA.
The generic ingredient in IDHIFA is enasidenib mesylate. Additional details are available on the enasidenib mesylate profile page.
When can drug patent challenges be filed against MAVYRET?
Generic name: glecaprevir; pibrentasvir
NCE-1 Date: August 2021
This drug has four hundred and forty patent family members in forty-four countries.
See drug price trends for MAVYRET.
The generic ingredient in MAVYRET is glecaprevir; pibrentasvir. Additional details are available on the glecaprevir; pibrentasvir profile page.
When can drug patent challenges be filed against BENZNIDAZOLE?
Generic name: benznidazole
NCE-1 Date: August 2021
BENZNIDAZOLE is a drug marketed by Chemo Research Sl.
This drug has four hundred and forty patent family members in forty-four countries.
The generic ingredient in BENZNIDAZOLE is benznidazole. There are two drug master file entries for this API. Additional details are available on the benznidazole profile page.
When can drug patent challenges be filed against ALIQOPA?
Generic name: copanlisib dihydrochloride
NCE-1 Date: September 2021
ALIQOPA is a drug marketed by Bayer Healthcare. There are four patents protecting this drug.
This drug has one hundred and fifty-two patent family members in fifty countries.
See drug price trends for ALIQOPA.
The generic ingredient in ALIQOPA is copanlisib dihydrochloride. Additional details are available on the copanlisib dihydrochloride profile page.
When can drug patent challenges be filed against SOLOSEC?
Generic name: secnidazole
NCE-1 Date: September 2021
This drug has fifteen patent family members in five countries.
See drug price trends for SOLOSEC.
The generic ingredient in SOLOSEC is secnidazole. There are two drug master file entries for this API. Additional details are available on the secnidazole profile page.
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 forty-nine 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 patent family members in forty-four 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 patent family members in forty-four 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 six patent family members in twenty-seven 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 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 seven 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 RHOPRESSA?
Generic name: netarsudil mesylate
NCE-1 Date: December 2021
This drug has fifty-one 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-one 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-five 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 five patent family members in two 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 eighty-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 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 fifty-eight patent family members in forty 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 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 patents protecting this drug.
This drug has three hundred and forty-three 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 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 one patent family members in forty-one 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.
