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-one patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and ninety-one 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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Summary for AKYNZEO
| International Patents: | 191 |
| US Patents: | 21 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 9 |
| Drug Prices: | Drug price information for AKYNZEO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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
*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 |
|---|---|
| Simon Williamson Clinic | Phase 2 |
| Helsinn Healthcare SA | Phase 2 |
| HK inno.N Corporation | Phase 1 |
Pharmacology 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-three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AKYNZEO is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Physiologically balanced injectable formulations of fosnetupitant
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Crystalline forms of an NK-1 antagonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted piperaziniums for the treatment of emesis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING EMESIS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING EMESIS
Substituted 4-phenyl pyridines having anti-emetic effect
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions and methods for treating centrally mediated nausea and vomiting
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up |
| Helsinn Hlthcare | AKYNZEO | netupitant; palonosetron hydrochloride | CAPSULE;ORAL | 205718-001 | Oct 10, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: FORMULACIONES INYECTABLES FISIOLÓGICAMENTE BALANCEADAS DE FOSNETUPITANT
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 15323515
Estimated Expiration: ⤷ Sign Up
Patent: 17276588
Patent: Physiologically balanced injectable formulations of fosnetupitant
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2018074655
Patent: formulação injetável de fosnetupitant e método de fabricação de uma formulação
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 60599
Estimated Expiration: ⤷ Sign Up
Patent: 25837
Patent: FORMULATIONS INJECTABLES PHYSIOLOGIQUEMENT EQUILIBREES DE FOSNETUPITANT (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 18003338
Patent: Formulaciones inyectables fisiológicamente balanceadas de fosnetupitant.
Estimated Expiration: ⤷ Sign Up
China
Patent: 7001275
Estimated Expiration: ⤷ Sign Up
Patent: 9310627
Patent: 福奈妥匹坦的生理平衡注射制剂 (Physiologically balanced injectable formulations of fosnetupitant)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 18011686
Patent: Formulaciones inyectables fisiológicamente balanceadas de fosnetupitant
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0200196
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 22755
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 35980
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 19000169
Patent: FORMULACIONES INYECTABLES FISIOLÓGICAMENTE BALANCEADAS DE FOSNETUPITANT
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 6605
Patent: ФИЗИОЛОГИЧЕСКИ СБАЛАНСИРОВАННЫЙ СОСТАВ ДЛЯ ИНЪЕКЦИЙ, ВКЛЮЧАЮЩИЙ ФОСНЕТУПИТАНТ (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATION OF FOSNETUPITANT)
Estimated Expiration: ⤷ Sign Up
Patent: 1892837
Patent: ФИЗИОЛОГИЧЕСКИ СБАЛАНСИРОВАННЫЕ СОСТАВЫ ДЛЯ ИНЪЕКЦИЙ, ВКЛЮЧАЮЩИЕ ФОСНЕТУПИТАНТ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 97871
Estimated Expiration: ⤷ Sign Up
Patent: 35980
Patent: FORMULATIONS INJECTABLES DE FOSNETUPITANT PHYSIOLOGIQUEMENT EQUILIBREES (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Estimated Expiration: ⤷ Sign Up
Patent: 26231
Patent: FORMULATIONS INJECTABLES DE FOSNETUPITANT PHYSIOLOGIQUEMENT ÉQUILIBRÉES (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3126
Patent: פורמולציות להזרקה של פוסנטופיטנט המאוזנות פיזיולוגית (Physiologically balanced injectable formulations of fosnetupitant)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 36817
Estimated Expiration: ⤷ Sign Up
Patent: 23084
Estimated Expiration: ⤷ Sign Up
Patent: 17529380
Estimated Expiration: ⤷ Sign Up
Patent: 19521102
Patent: ホスネツピタントの生理学的にバランスのとれた注射可能な製剤
Estimated Expiration: ⤷ Sign Up
Patent: 21183639
Patent: ホスネツピタントの生理学的にバランスのとれた注射可能な製剤 (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 0170137
Patent: صيغ قابلة للحقن متوازنة فسيولوجياً من فوسنيتوبيتانت (Physiologically balanced injectable formulations of fosnetupitant)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 35980
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4081
Patent: PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 18015036
Patent: FORMULACIONES INYECTABLES FISIOLOGICAMENTE BALANCEADAS DE FOSNETUPITANT. (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT.)
Estimated Expiration: ⤷ Sign Up
Moldova, Republic of
Patent: 35980
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 513
Patent: Formulations injectables de fosnetupitant physiologiquement equilibrees
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 7865
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 190347
Patent: FORMULACIONES INYECTABLES FISIOLOGICAMENTE BALANCEADAS DE FOSNETUPITANT
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 018502524
Patent: PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 35980
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 35980
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 852
Patent: FIZIOLOŠKI BALANSIRANE INJEKTABILNE FORMULACIJE FOSNETUPITANTA (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201809708P
Patent: PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 35980
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1807932
Patent: PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2459416
Estimated Expiration: ⤷ Sign Up
Patent: 170063768
Patent: ＮＫ-1 길항제의 결정질 형태 (-1 CRYSTALLINE FORMS OF AN NK-1 ANTAGONIST)
Estimated Expiration: ⤷ Sign Up
Patent: 190015276
Patent: 포스네투피탄트의 생리학적으로 균형잡힌 주사가능 제제
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 71226
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 25191
Estimated Expiration: ⤷ Sign Up
Patent: 1613888
Patent: Crystalline forms of an NK-1 antagonist
Estimated Expiration: ⤷ Sign Up
Patent: 1801727
Patent: Physiologically balanced injectable formulations of fosnetupitant
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 2285
Patent: ФІЗІОЛОГІЧНО ЗБАЛАНСОВАНІ СКЛАДИ ДЛЯ ІН'ЄКЦІЙ, ЯКІ ВКЛЮЧАЮТЬ ФОСНЕТУПІТАНТ (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 273
Patent: FORMULACIONES INYECTABLES FISIOLÓGICAMENTE BALANCEADAS DE FOSNETUPITANT
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| China | 109310627 | 福奈妥匹坦的生理平衡注射制剂 (Physiologically balanced injectable formulations of fosnetupitant) | ⤷ Sign Up |
| Poland | 166277 | ⤷ Sign Up | |
| Brazil | 112018074655 | formulação injetável de fosnetupitant e método de fabricação de uma formulação | ⤷ Sign Up |
| Croatia | P20000097 | DERIVATI 4-FENIL-PIRIDINA (4-PHENYL-PYRIDINE DERIVATIVES) | ⤷ Sign Up |
| Australia | 2015323515 | ⤷ Sign Up | |
| Israel | 219576 | תכשירים ושיטות לטיפול בבחילות והקאות מתווכות מרכזית (Compositions for treating centrally mediated nausea and vomiting) | ⤷ Sign Up |
| Slovakia | 287912 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AKYNZEO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1035115 | PA2015036 | Lithuania | ⤷ Sign Up | PRODUCT NAME: NETUPITANTUM; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
| 1035115 | C300758 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
| 0430190 | C00430190/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 1035115 | 92745 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527 |
| 0430190 | 91162 | Luxembourg | ⤷ Sign Up | 91162, EXPIRES: 20151127 |
| 2785706 | 301047 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FOSNETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FOSNETUPITANTCHLORIDEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1001 20200318 |
| 2785706 | LUC00158 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318 |
| >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.
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