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Last Updated: September 27, 2023

48 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2023 - 2024

Loss of Exclusivity / End of Market Exclusivity Period dates

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Preferred citation:
Friedman, Yali, "48 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2023 - 2024" DrugPatentWatch.com thinkBiotech, 2023 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 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 thirty-one patents protecting this drug.

This drug has four hundred and seventy-six patent family members in forty-four countries. There has been litigation on patents covering TRIKAFTA (COPACKAGED)

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 fifteen patents protecting this drug.

This drug has one hundred and thirty-eight 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.

When can drug patent challenges be filed against PIZENSY?

Generic name: lactitol
NCE-1 Date: February 2024

PIZENSY is a drug marketed by Braintree Labs. There is one patent protecting this drug.

The generic ingredient in PIZENSY is lactitol. There are four drug master file entries for this API. Additional details are available on the lactitol profile page.

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Serving leading biopharmaceutical companies globally:

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