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 22, 2019

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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 thirteen patents protecting this drug.

This drug has two hundred and ten 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
Drug Prices for AKYNZEO

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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.

Recent Clinical Trials for AKYNZEO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
VIFORFRANCEPhase 4
Christina RuhlmannPhase 2/Phase 3
Helsinn Healthcare SAPhase 3

See all AKYNZEO clinical trials

Recent Litigation for AKYNZEO

Identify potential future generic entrants

District Court Litigation
Case NameDate
Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.2015-12-04
HELSINN HEALTHCARE S.A. v. HOSPIRA, INC.2015-03-23
Helsinn Healthcare SA v. Cipla Ltd.2013-04-16

See all AKYNZEO litigation

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

Supplementary Protection Certificates for AKYNZEO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1035115 2015/030 Ireland   Start Trial PRODUCT NAME: NETUPITANT OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1001 20150527
1035115 43/2015 Austria   Start Trial PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: EU/1/15/1001 20150527
1035115 15C0049 France   Start Trial PRODUCT NAME: NETUPITANT OU L'UN DE SES SELS D'ADDITION D'ACIDES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1001 20150529
1035115 300758 Netherlands   Start Trial PRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1001 20150527
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Moodys
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Colorcon
Boehringer Ingelheim

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