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Last Updated: May 22, 2022

AKYNZEO Drug Patent Profile


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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 eighteen patents protecting this drug.

This drug has two hundred and fifty-seven 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 was eligible for patent challenges on April 19, 2022.

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:257
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

AKYNZEO is protected by twenty US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AKYNZEO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting AKYNZEO

Solution comprising the chloride hydrochloride salt of 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-to- lyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-IUM-(fosnet- upitant) and palonosetron hydrochloride in combination with dexamethasone as a neurokinin receptor modulator
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY

Crystalline forms of an NK-1 antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Physiologically balanced injectable formulations of fosnetupitant
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of an NK-1 antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted piperaziniums for the treatment of emesis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC CHEMOTHERAPY

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY

Crystalline forms of an NK-1 antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

4-phenyl-pyridine derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted 4-phenyl pyridines having anti-emetic effect
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC CHEMOTHERAPY

Methods of treating emesis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC CHEMOTHERAPY

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC CHEMOTHERAPY

4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tol- yl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium as a neurokinin receptor modulator
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY

Substituted piperaziniums for the treatment of emesis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC CHEMOTHERAPY

Crystalline forms of an NK-1 antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting AKYNZEO

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride POWDER;INTRAVENOUS 210493-001 Apr 19, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for AKYNZEO

When does loss-of-exclusivity occur for AKYNZEO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 8676
Estimated Expiration: See Plans and Pricing

Australia

Patent: 15323515
Estimated Expiration: See Plans and Pricing

Patent: 17276588
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2018074655
Estimated Expiration: See Plans and Pricing

Canada

Patent: 60599
Estimated Expiration: See Plans and Pricing

Patent: 25837
Estimated Expiration: See Plans and Pricing

Chile

Patent: 18003338
Estimated Expiration: See Plans and Pricing

China

Patent: 7001275
Estimated Expiration: See Plans and Pricing

Patent: 9310627
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 18011686
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0200196
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 35980
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 19000169
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 6605
Estimated Expiration: See Plans and Pricing

Patent: 1892837
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 97871
Estimated Expiration: See Plans and Pricing

Patent: 35980
Estimated Expiration: See Plans and Pricing

Patent: 26231
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3126
Estimated Expiration: See Plans and Pricing

Japan

Patent: 36817
Estimated Expiration: See Plans and Pricing

Patent: 17529380
Estimated Expiration: See Plans and Pricing

Patent: 19521102
Estimated Expiration: See Plans and Pricing

Patent: 21183639
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 35980
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 18015036
Estimated Expiration: See Plans and Pricing

Moldova, Republic of

Patent: 35980
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 513
Estimated Expiration: See Plans and Pricing

Peru

Patent: 190347
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 018502524
Estimated Expiration: See Plans and Pricing

Poland

Patent: 35980
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 35980
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 852
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201809708P
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 35980
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1807932
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170063768
Estimated Expiration: See Plans and Pricing

Patent: 190015276
Estimated Expiration: See Plans and Pricing

Spain

Patent: 71226
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 25191
Estimated Expiration: See Plans and Pricing

Patent: 1613888
Estimated Expiration: See Plans and Pricing

Patent: 1801727
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 2285
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 273
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AKYNZEO around the world.

Country Patent Number Title Estimated Expiration
Denmark 1394150 See Plans and Pricing
Germany 60045564 See Plans and Pricing
Serbia 59852 FIZIOLOŠKI BALANSIRANE INJEKTABILNE FORMULACIJE FOSNETUPITANTA (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT) See Plans and Pricing
Hong Kong 1214148 用於治療中樞介導的噁心及嘔吐的組合物及方法 (COMPOSITIONS FOR TREATING CENTRALLY MEDIATED NAUSEA AND VOMITING) See Plans and Pricing
Nicaragua 201400043 4 - FENIL - PIRIDINAS SUSTITUIDAS PARA EL TRATAMIENTO DE ENFERMEDADES RELACIONADAS CON EL RECEPTOR DE NK1 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AKYNZEO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1035115 15C0049 France See Plans and Pricing PRODUCT NAME: NETUPITANT OU L'UN DE SES SELS D'ADDITION D'ACIDES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1001 20150529
1035115 C300758 Netherlands See Plans and Pricing PRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/15/1001 20150527
0430190 18/2005 Austria See Plans and Pricing PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
1035115 300758 Netherlands See Plans and Pricing PRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1001 20150527
1035115 PA2015036,C1035115 Lithuania See Plans and Pricing PRODUCT NAME: NETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20150527
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.