➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
McKinsey
Express Scripts
Merck
Medtronic

Last Updated: April 17, 2021

DrugPatentWatch Database Preview

AKYNZEO Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

Which patents cover Akynzeo, and what generic alternatives are available?

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

This drug has two hundred and fifty-two 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

< Available with Subscription >

  Start Trial

Summary for AKYNZEO
International Patents:252
US Patents:17
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Clinical Trials: 6
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
VIFORFRANCEPhase 4
Christina RuhlmannPhase 2/Phase 3

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   Start Trial   Start Trial Y Y   Start Trial
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes   Start Trial   Start Trial 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
>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
2785706 301047 Netherlands   Start Trial PRODUCT NAME: FOSNETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FOSNETUPITANTCHLORIDEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1001 20200318
1035115 CR 2015 00044 Denmark   Start Trial PRODUCT NAME: NETUPITANT; REG. NO/DATE: EU/1/15/1001 20150529
2785706 122020000050 Germany   Start Trial PRODUCT NAME: FOSNETUPITANT; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Moodys
Mallinckrodt
Merck
Colorcon
Baxter

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 verification 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.