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Last Updated: May 19, 2022

47 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, "47 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 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 four patents protecting this drug.

This drug has thirty-seven patent family members in twenty-three 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 seven patent family members in seven countries.

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 sixteen patents protecting this drug.

This drug has three hundred and thirteen patent family members in thirty-three 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 ninety 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.

When can drug patent challenges be filed against EPIDIOLEX?

Generic name: cannabidiol
NCE-1 Date: September 2022

EPIDIOLEX is a drug marketed by Gw Res Ltd. There are twenty-one patents protecting this drug.

This drug has one hundred and thirty-one patent family members in twenty-five countries.

See drug price trends for EPIDIOLEX.

The generic ingredient in EPIDIOLEX is cannabidiol. There are nine drug master file entries for this API. Additional details are available on the cannabidiol profile page.

When can drug patent challenges be filed against MULTRYS?

Generic name: cupric sulfate; manganese sulfate; selenious acid; zinc sulfate
NCE-1 Date: April 2023

MULTRYS is a drug marketed by Am Regent.

This drug has one hundred and sixty-three patent family members in forty-one countries.

The generic ingredient in MULTRYS is cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. Additional details are available on the cupric sulfate; manganese sulfate; selenious acid; zinc sulfate profile page.

When can drug patent challenges be filed against TRALEMENT?

Generic name: cupric sulfate; manganese sulfate; selenious acid; zinc sulfate
NCE-1 Date: April 2023

TRALEMENT is a drug marketed by Am Regent.

This drug has one hundred and sixty-three patent family members in forty-one countries.

See drug price trends for TRALEMENT.

The generic ingredient in TRALEMENT is cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. Additional details are available on the cupric sulfate; manganese sulfate; selenious acid; zinc sulfate profile page.

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