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Last Updated: December 9, 2021

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AKYNZEO Drug Patent Profile


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When do Akynzeo patents expire, and when can generic versions of Akynzeo launch?

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

This drug has two hundred and fifty-six patent family members in sixty-eight 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.

DrugPatentWatch® Generic Entry Outlook for Akynzeo

Akynzeo will be eligible for patent challenges on April 19, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 25, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for AKYNZEO
International Patents:256
US Patents:18
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Clinical Trials: 8
Formulation / Manufacturing:see details
Drug Prices: Drug price information for AKYNZEO
What excipients (inactive ingredients) are in AKYNZEO?AKYNZEO excipients list
DailyMed Link:AKYNZEO at DailyMed
Drug patent expirations by year for AKYNZEO
Drug Prices for AKYNZEO

See drug prices for AKYNZEO

DrugPatentWatch® Estimated 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
HK inno.N CorporationPhase 1
Helsinn Healthcare SAPhase 4
VIFORFRANCEPhase 4

See all AKYNZEO clinical trials

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 fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride POWDER;INTRAVENOUS 210493-001 Apr 19, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 92745 Luxembourg ⤷  Try it Free PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
1035115 PA2015036 Lithuania ⤷  Try it Free PRODUCT NAME: NETUPITANTUM; REGISTRATION NO/DATE: EU/1/15/1001 20150527
2785706 PA2020510 Lithuania ⤷  Try it Free PRODUCT NAME: FOSNETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20200316
0430190 C00430190/01 Switzerland ⤷  Try it Free FORMER REPRESENTATIVE: BOHEST AG, CH
0430190 91162 Luxembourg ⤷  Try it Free 91162, EXPIRES: 20151127
0430190 SPC/GB05/032 United Kingdom ⤷  Try it Free PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322
2785706 132020000000094 Italy ⤷  Try it Free PRODUCT NAME: FOSNETUPITANT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL SUO SALE CLORURO CLORIDRATO(AKYNZEO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1001/001-002, 20200316
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Moodys
Express Scripts
McKesson
Johnson and Johnson

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