Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 16, 2019

21 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2019 - 2020

Loss of Exclusivity / End of Market Exclusivity Period dates

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Preferred citation:
Friedman, Yali, "21 Drugs Facing NCE-1 / Abbreviated New Drug Application acceptance dates in 2019 - 2020" DrugPatentWatch.com thinkBiotech, 2019 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 UPTRAVI?

Generic name: selexipag
NCE-1 Date: December 2019

UPTRAVI is a drug marketed by Actelion Pharms Ltd. There are four patents protecting this drug.

This drug has one hundred patent family members in thirty-three countries. There has been litigation on patents covering UPTRAVI

See drug price trends for UPTRAVI.

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

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 fifteen patents protecting this drug.

This drug has one hundred and forty-two 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 forty-nine 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 three 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 fifty-seven 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 EUCRISA?

Generic name: crisaborole
NCE-1 Date: December 2020

Drug Price Trends for EUCRISA
EUCRISA is a drug marketed by Anacor Pharms Inc. There are four patents protecting this drug.

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

See drug price trends for EUCRISA.

The generic ingredient in EUCRISA is crisaborole. There are three drug master file entries for this API. Additional details are available on the crisaborole profile page.

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Serving leading biopharmaceutical companies globally:

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Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.