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Last Updated: August 17, 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 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-one 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-two patents protecting this drug.

This drug has one hundred and thirty-four 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-seven 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-seven 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.

When can drug patent challenges be filed against VIJOICE?

Generic name: alpelisib
NCE-1 Date: May 2023

VIJOICE is a drug marketed by Novartis. There are two patents protecting this drug.

This drug has fifty-seven patent family members in forty-eight countries.

The generic ingredient in VIJOICE is alpelisib. Additional details are available on the alpelisib profile page.

When can drug patent challenges be filed against RECARBRIO?

Generic name: cilastatin sodium; imipenem; relebactam
NCE-1 Date: July 2023

RECARBRIO is a drug marketed by Msd Merck Co. There is one patent protecting this drug.

This drug has sixty-four patent family members in thirty-six countries.

See drug price trends for RECARBRIO.

The generic ingredient in RECARBRIO is cilastatin sodium; imipenem; relebactam. There are sixteen drug master file entries for this API. Additional details are available on the cilastatin sodium; imipenem; relebactam profile page.

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