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
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 |


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
Sponsor | Phase |
---|---|
HK inno.N Corporation | Phase 1 |
Helsinn Healthcare SA | Phase 4 |
VIFORFRANCE | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for AKYNZEO
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
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 | See Plans and Pricing | See Plans and Pricing |
>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: 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 |