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Last Updated: November 30, 2022

41 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, "41 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 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-nine patent family members in forty-two 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-nine patent family members in forty-two 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-eight 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-five patent family members in thirty-seven 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.

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

Generic name: elexacaftor, ivacaftor, tezacaftor; ivacaftor
NCE-1 Date: October 2023

TRIKAFTA (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-three patents protecting this drug.

This drug has four hundred and forty-two patent family members in forty-three 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 CAPLYTA?

Generic name: lumateperone tosylate
NCE-1 Date: December 2023

Drug Price Trends for CAPLYTA
CAPLYTA is a drug marketed by Intra-cellular. There are fourteen patents protecting this drug.

This drug has one hundred and twenty-seven patent family members in twenty countries. There has been litigation on patents covering CAPLYTA

See drug price trends for CAPLYTA.

The generic ingredient in CAPLYTA is lumateperone tosylate. Additional details are available on the lumateperone tosylate profile page.

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