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Last Updated: May 10, 2021

34 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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Preferred citation:
Friedman, Yali, "34 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 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 ninety patent family members in twenty-four 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 VOSEVI?

Generic name: sofosbuvir; velpatasvir; voxilaprevir
NCE-1 Date: July 2021

VOSEVI is a drug marketed by Gilead Sciences Inc. There are seventeen patents protecting this drug.

This drug has five hundred and fifty-nine 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 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-three patent family members in forty-five 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 ROCKLATAN?

Generic name: latanoprost; netarsudil dimesylate
NCE-1 Date: December 2021

Drug Price Trends for ROCKLATAN
ROCKLATAN is a drug marketed by Aerie Pharms Inc. There are eleven patents protecting this drug.

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

Drug Price Trends for SEGLUROMET
SEGLUROMET is a drug marketed by Merck Sharp Dohme. There are three patents protecting this drug.

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 STEGLUJAN?

Generic name: ertugliflozin; sitagliptin phosphate
NCE-1 Date: December 2021

Drug Price Trends for STEGLUJAN
STEGLUJAN is a drug marketed by Merck Sharp Dohme. There are five patents protecting this drug.

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 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 seven patent family members in four 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

Drug Price Trends for BIKTARVY
BIKTARVY is a drug marketed by Gilead Sciences Inc. There are ten patents protecting this drug.

This drug has four hundred and eighty-nine 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 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 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 sixty-four 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 AKYNZEO?

Generic name: fosnetupitant chloride hydrochloride; palonosetron hydrochloride
NCE-1 Date: April 2022

AKYNZEO is a drug marketed by Helsinn Hlthcare. There are seventeen patents protecting this drug.

This drug has two hundred and fifty-two 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 LOKELMA?

Generic name: sodium zirconium cyclosilicate
NCE-1 Date: May 2022

Drug Price Trends for LOKELMA
LOKELMA is a drug marketed by Astrazeneca. There are twelve patents protecting this drug.

This drug has one hundred and seventeen 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.

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