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 nineteen patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and sixty-one 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.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for AKYNZEO
International Patents: | 261 |
US Patents: | 19 |
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 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
Sponsor | Phase |
---|---|
HK inno.N Corporation | Phase 1 |
Helsinn Healthcare SA | Phase 4 |
VIFORFRANCE | Phase 4 |
Pharmacology for AKYNZEO
Anatomical Therapeutic Chemical (ATC) Classes for AKYNZEO
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-one US patents and one FDA Regulatory Exclusivity.
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
4-phenyl-pyridine derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
FDA Regulatory Exclusivity protecting AKYNZEO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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
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 |
---|---|---|---|
Ecuador | SP19000169 | FORMULACIONES INYECTABLES FISIOLĂ“GICAMENTE BALANCEADAS DE FOSNETUPITANT | ⤷ Try a Trial |
South Korea | 102459416 | ⤷ Try a Trial | |
Poland | 287961 | ⤷ Try a Trial | |
Taiwan | I595873 | ⤷ 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 | PA2015036,C1035115 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: NETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
2785706 | 2020C/516 | Belgium | ⤷ Try a Trial | PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318 |
0430190 | 300194 | Netherlands | ⤷ Try a Trial | 300194, 20101127, EXPIRES: 20151126 |
0430190 | 91162 | Luxembourg | ⤷ Try a Trial | 91162, EXPIRES: 20151127 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |