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Last Updated: December 2, 2023

49 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, "49 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 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 sixteen patents protecting this drug.

This drug has one hundred and forty-six 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.

When can drug patent challenges be filed against GALLIUM GA 68 GOZETOTIDE?

Generic name: gallium ga-68 gozetotide
NCE-1 Date: December 2024

GALLIUM GA 68 GOZETOTIDE is a drug marketed by Univ Ca Los Angeles and Univ Of Ca San Fran

This drug has ninety-two patent family members in twenty-one countries.

The generic ingredient in GALLIUM GA 68 GOZETOTIDE is gallium ga-68 gozetotide. There are sixteen drug master file entries for this API. Additional details are available on the gallium ga-68 gozetotide profile page.

When can drug patent challenges be filed against MYFEMBREE?

Generic name: estradiol; norethindrone acetate; relugolix
NCE-1 Date: December 2024

Drug Price Trends for MYFEMBREE
MYFEMBREE is a drug marketed by Myovant Sciences. There are six patents protecting this drug.

This drug has ninety-four patent family members in thirty-two countries.

See drug price trends for MYFEMBREE.

The generic ingredient in MYFEMBREE is estradiol; norethindrone acetate; relugolix. There are seventy-five drug master file entries for this API. Additional details are available on the estradiol; norethindrone acetate; relugolix profile page.

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Serving leading biopharmaceutical companies globally:

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