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Last Updated: April 21, 2024

50 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2024 - 2025

Loss of Exclusivity / End of Market Exclusivity Period dates

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Preferred citation:
Friedman, Yali, "50 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2024 - 2025" DrugPatentWatch.com thinkBiotech, 2024 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 DETECTNET?

Generic name: copper cu-64 dotatate
NCE-1 Date: September 2024

DETECTNET is a drug marketed by Radiomedix. There are three patents protecting this drug.

This drug has eleven patent family members in six countries.

See drug price trends for DETECTNET.

The generic ingredient in DETECTNET is copper cu-64 dotatate. There are fifteen drug master file entries for this API. Additional details are available on the copper cu-64 dotatate 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-four 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 one hundred and thirty-four patent family members in thirty-four 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.

When can drug patent challenges be filed against CABENUVA KIT?

Generic name: cabotegravir; rilpivirine
NCE-1 Date: January 2025

CABENUVA KIT is a drug marketed by Viiv Hlthcare. There are five patents protecting this drug.

This drug has three hundred and ninety-two patent family members in fifty-one countries. There has been litigation on patents covering CABENUVA KIT

The generic ingredient in CABENUVA KIT is cabotegravir; rilpivirine. Additional details are available on the cabotegravir; rilpivirine profile page.

When can drug patent challenges be filed against PEPAXTO?

Generic name: melphalan flufenamide hydrochloride
NCE-1 Date: February 2025

PEPAXTO is a drug marketed by Oncopeptides Ab. There are six patents protecting this drug.

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

The generic ingredient in PEPAXTO is melphalan flufenamide hydrochloride. There are twelve drug master file entries for this API. Additional details are available on the melphalan flufenamide hydrochloride profile page.

When can drug patent challenges be filed against NEXTSTELLIS?

Generic name: drospirenone; estetrol
NCE-1 Date: April 2025

Drug Price Trends for NEXTSTELLIS
NEXTSTELLIS is a drug marketed by Mayne Pharma. There are two patents protecting this drug.

This drug has one hundred and fifty-seven patent family members in forty-four countries.

See drug price trends for NEXTSTELLIS.

The generic ingredient in NEXTSTELLIS is drospirenone; estetrol. There are eleven drug master file entries for this API. Additional details are available on the drospirenone; estetrol profile page.

When can drug patent challenges be filed against AZSTARYS?

Generic name: dexmethylphenidate hydrochloride; serdexmethylphenidate chloride
NCE-1 Date: May 2025

Drug Price Trends for AZSTARYS
AZSTARYS is a drug marketed by Commave Therap. There are six patents protecting this drug.

This drug has seventy-one patent family members in twenty-eight countries.

See drug price trends for AZSTARYS.

The generic ingredient in AZSTARYS is dexmethylphenidate hydrochloride; serdexmethylphenidate chloride. There are six drug master file entries for this API. Additional details are available on the dexmethylphenidate hydrochloride; serdexmethylphenidate chloride profile page.

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