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Last Updated: April 7, 2020

31 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, "31 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 NUPLAZID?

Generic name: pimavanserin tartrate
NCE-1 Date: April 2020

NUPLAZID is a drug marketed by Acadia Pharms Inc. There are seventeen patents protecting this drug.

This drug has one hundred and forty-six patent family members in twenty-seven countries.

See drug price trends for NUPLAZID.

The generic ingredient in NUPLAZID is pimavanserin tartrate. There are two drug master file entries for this API. Additional details are available on the pimavanserin tartrate profile page.

When can drug patent challenges be filed against EPCLUSA?

Generic name: sofosbuvir; velpatasvir
NCE-1 Date: June 2020

Drug Price Trends for EPCLUSA
EPCLUSA is a drug marketed by Gilead Sciences Inc. There are fourteen patents protecting this drug.

This drug has four hundred and sixty-five patent family members in forty-seven countries. There has been litigation on patents covering EPCLUSA

See drug price trends for EPCLUSA.

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

When can drug patent challenges be filed against SMOFLIPID 20%?

Generic name: fish oil; medium chain triglycerides; olive oil; soybean oil
NCE-1 Date: July 2020

SMOFLIPID 20% is a drug marketed by Fresenius Kabi Usa.

This drug has one hundred and nine patent family members in twenty-one countries.

The generic ingredient in SMOFLIPID 20% is fish oil; medium chain triglycerides; olive oil; soybean oil. There are six drug master file entries for this API. Additional details are available on the fish oil; medium chain triglycerides; olive oil; soybean oil profile page.

When can drug patent challenges be filed against SOLIQUA 100/33?

Generic name: insulin glargine; lixisenatide
NCE-1 Date: July 2020

SOLIQUA 100/33 is a drug marketed by Sanofi-aventis Us. There are twenty-six patents protecting this drug.

This drug has four hundred and seventy-five patent family members in fifty countries. There has been litigation on patents covering SOLIQUA 100/33

The generic ingredient in SOLIQUA 100/33 is insulin glargine; lixisenatide. There are forty drug master file entries for this API. Additional details are available on the insulin glargine; lixisenatide profile page.

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 thirty-eight patent family members in forty-nine 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.

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