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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Farmers Insurance
Express Scripts
US Army
Colorcon
Daiichi Sankyo
Argus Health
Federal Trade Commission
Chinese Patent Office

Generated: August 20, 2018

DrugPatentWatch Database Preview

AKYNZEO Drug Profile

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When do Akynzeo patents expire, and what generic alternatives are available?

Akynzeo is a drug marketed by Helsinn Hlthcare and is included in two NDAs. There are eleven patents protecting this drug.

This drug has two hundred and five patent family members in sixty-seven countries.

The generic ingredient in AKYNZEO is fosnetupitant chloride hydrochloride; palonosetron hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fosnetupitant chloride hydrochloride; palonosetron hydrochloride profile page.

Drug patent expirations by year for AKYNZEO
Generic Entry Opportunity Date for AKYNZEO
Generic Entry Dates for AKYNZEO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for AKYNZEO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for AKYNZEO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride POWDER;INTRAVENOUS 210493-001 Apr 19, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride POWDER;INTRAVENOUS 210493-001 Apr 19, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for AKYNZEO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,479,483 4-phenyl-pyridine derivatives ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for AKYNZEO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
15/030 Ireland ➤ Sign Up PRODUCT NAME: NETUPITANT OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1001 20150527
0758 Netherlands ➤ Sign Up PRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1001 20150527
2015036,C1035115 Lithuania ➤ Sign Up PRODUCT NAME: NETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20150527
1035115/01 Switzerland ➤ Sign Up PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: SWISSMEDIC 65499 06.11.2015
745 Luxembourg ➤ Sign Up PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
/2015 Austria ➤ Sign Up PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: EU/1/15/1001 20150527
2015036 Lithuania ➤ Sign Up PRODUCT NAME: NETUPITANTUM; REGISTRATION NO/DATE: EU/1/15/1001 20150527
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Baxter
Dow
Moodys
Teva
Covington
Healthtrust
Boehringer Ingelheim

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