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Last Updated: August 7, 2020

27 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2020 - 2021

Loss of Exclusivity / End of Market Exclusivity Period dates

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Preferred citation:
Friedman, Yali, "27 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2020 - 2021" DrugPatentWatch.com thinkBiotech, 2020 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 KISQALI FEMARA CO-PACK (COPACKAGED)?

Generic name: letrozole; ribociclib succinate
NCE-1 Date: March 2021

KISQALI FEMARA CO-PACK (COPACKAGED) is a drug marketed by Novartis. There are seven patents protecting this drug.

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

The generic ingredient in KISQALI FEMARA CO-PACK (COPACKAGED) is letrozole; ribociclib succinate. There are twenty-four drug master file entries for this API. Additional details are available on the letrozole; ribociclib succinate profile page.

When can drug patent challenges be filed against BAXDELA?

Generic name: delafloxacin meglumine
NCE-1 Date: June 2021

BAXDELA is a drug marketed by Melinta. There are thirteen patents protecting this drug.

This drug has seventy-nine patent family members in seventeen countries. There has been litigation on patents covering BAXDELA

See drug price trends for BAXDELA.

The generic ingredient in BAXDELA is delafloxacin meglumine. Additional details are available on the delafloxacin meglumine profile page.

When can drug patent challenges be filed against VOSEVI?

Generic name: sofosbuvir; velpatasvir; voxilaprevir
NCE-1 Date: July 2021

VOSEVI is a drug marketed by Gilead Sciences Inc. There are fifteen patents protecting this drug.

This drug has five hundred and twenty-two patent family members in forty-eight countries. There has been litigation on patents covering VOSEVI

See drug price trends for VOSEVI.

The generic ingredient in VOSEVI is sofosbuvir; velpatasvir; voxilaprevir. There are nine drug master file entries for this API. Additional details are available on the sofosbuvir; velpatasvir; voxilaprevir profile page.

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