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Last Updated: May 18, 2024

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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 twenty patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-five patent family members in fifty-one 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.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for AKYNZEO
Drug Prices for AKYNZEO

See drug prices for AKYNZEO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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

Paragraph IV (Patent) Challenges for AKYNZEO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AKYNZEO Solution in SDV fosnetupitant chloride hydrochloride; palonosetron hydrochloride 235 mg/0.25 mg per 20 mL 210493 1 2022-04-19

US Patents and Regulatory Information for AKYNZEO

AKYNZEO is protected by twenty-two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AKYNZEO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Physiologically balanced injectable formulations of fosnetupitant
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystalline forms of an NK-1 antagonist
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Substituted piperaziniums for the treatment of emesis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING EMESIS

Substituted 4-phenyl pyridines having anti-emetic effect
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AKYNZEO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 ⤷  Try a Trial ⤷  Try a Trial
Helsinn Hlthcare AKYNZEO netupitant; palonosetron hydrochloride CAPSULE;ORAL 205718-001 Oct 10, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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: ⤷  Try a Trial

Australia

Patent: 15323515
Estimated Expiration: ⤷  Try a Trial

Patent: 17276588
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2018074655
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 60599
Estimated Expiration: ⤷  Try a Trial

Patent: 25837
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 18003338
Estimated Expiration: ⤷  Try a Trial

China

Patent: 7001275
Estimated Expiration: ⤷  Try a Trial

Patent: 9310627
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 18011686
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0200196
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 22755
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 35980
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 19000169
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 6605
Estimated Expiration: ⤷  Try a Trial

Patent: 1892837
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 97871
Estimated Expiration: ⤷  Try a Trial

Patent: 35980
Estimated Expiration: ⤷  Try a Trial

Patent: 26231
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3126
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 36817
Estimated Expiration: ⤷  Try a Trial

Patent: 23084
Estimated Expiration: ⤷  Try a Trial

Patent: 17529380
Estimated Expiration: ⤷  Try a Trial

Patent: 19521102
Estimated Expiration: ⤷  Try a Trial

Patent: 21183639
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 0170137
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 35980
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4081
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 18015036
Estimated Expiration: ⤷  Try a Trial

Moldova, Republic of

Patent: 35980
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 513
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 190347
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 018502524
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 35980
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 35980
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 852
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201809708P
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 35980
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1807932
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2459416
Estimated Expiration: ⤷  Try a Trial

Patent: 170063768
Estimated Expiration: ⤷  Try a Trial

Patent: 190015276
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 71226
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 25191
Estimated Expiration: ⤷  Try a Trial

Patent: 1613888
Estimated Expiration: ⤷  Try a Trial

Patent: 1801727
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 2285
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 273
Estimated Expiration: ⤷  Try a Trial

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
Eurasian Patent Organization 201400624 ЗАМЕЩЕННЫЕ 4-ФЕНИЛПИРИДИНЫ ДЛЯ ЛЕЧЕНИЯ БОЛЕЗНЕЙ, СВЯЗАННЫХ С РЕЦЕПТОРОМ NK-1 ⤷  Try a Trial
Poland 166272 ⤷  Try a Trial
Australia 2017276588 Physiologically balanced injectable formulations of fosnetupitant ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AKYNZEO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1035115 C01035115/01 Switzerland ⤷  Try a Trial PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: SWISSMEDIC 65499 06.11.2015
1035115 300758 Netherlands ⤷  Try a Trial PRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1001 20150527
2785706 C02785706/01 Switzerland ⤷  Try a Trial PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022
>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.