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Last Updated: January 25, 2022

46 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2022 - 2023

Loss of Exclusivity / End of Market Exclusivity Period dates

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Preferred citation:
Friedman, Yali, "46 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2022 - 2023" DrugPatentWatch.com thinkBiotech, 2022 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 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 nineteen patent family members in twelve 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 thirteen patents protecting this drug.

This drug has five hundred and five 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 four hundred and eighteen patent family members in forty-two 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-one patents protecting this drug.

This drug has three hundred and eighty-nine 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 AKYNZEO?

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

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

This drug has two hundred and fifty-seven 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 nineteen 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.

When can drug patent challenges be filed against ORIAHNN (COPACKAGED)?

Generic name: elagolix sodium,estradiol,norethindrone acetate; elagolix sodium
NCE-1 Date: July 2022

ORIAHNN (COPACKAGED) is a drug marketed by Abbvie Inc. There are seven patents protecting this drug.

This drug has fifty-five patent family members in twenty-four countries.

The generic ingredient in ORIAHNN (COPACKAGED) is elagolix sodium,estradiol,norethindrone acetate; elagolix sodium. Additional details are available on the elagolix sodium,estradiol,norethindrone acetate; elagolix sodium profile page.

When can drug patent challenges be filed against OMEGAVEN?

Generic name: fish oil triglycerides
NCE-1 Date: July 2022

OMEGAVEN is a drug marketed by Fresenius Kabi Usa. There are three patents protecting this drug.

This drug has five patent family members in four countries. There has been litigation on patents covering OMEGAVEN

See drug price trends for OMEGAVEN.

The generic ingredient in OMEGAVEN is fish oil triglycerides. There are six drug master file entries for this API. Additional details are available on the fish oil triglycerides profile page.

When can drug patent challenges be filed against ANNOVERA?

Generic name: ethinyl estradiol; segesterone acetate
NCE-1 Date: August 2022

ANNOVERA is a drug marketed by Therapeuticsmd Inc. There are six patents protecting this drug.

This drug has one patent family member in one country.

See drug price trends for ANNOVERA.

The generic ingredient in ANNOVERA is ethinyl estradiol; segesterone acetate. There are twenty-six drug master file entries for this API. Additional details are available on the ethinyl estradiol; segesterone acetate profile page.

When can drug patent challenges be filed against ONPATTRO?

Generic name: patisiran sodium
NCE-1 Date: August 2022

ONPATTRO is a drug marketed by Alnylam Pharms Inc. There are twenty-four patents protecting this drug.

This drug has four hundred and sixty-four patent family members in thirty-five countries. There has been litigation on patents covering ONPATTRO

See drug price trends for ONPATTRO.

The generic ingredient in ONPATTRO is patisiran sodium. Additional details are available on the patisiran sodium profile page.

When can drug patent challenges be filed against DELSTRIGO?

Generic name: doravirine; lamivudine; tenofovir disoproxil fumarate
NCE-1 Date: August 2022

DELSTRIGO is a drug marketed by Msd Merck Co. There are three patents protecting this drug.

This drug has eighty-six patent family members in forty-four countries.

The generic ingredient in DELSTRIGO is doravirine; lamivudine; tenofovir disoproxil fumarate. Additional details are available on the doravirine; lamivudine; tenofovir disoproxil fumarate profile page.

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