AKYNZEO Drug Patent Profile
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When do Akynzeo patents expire, and when can generic versions of Akynzeo launch?
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-three patent family members in fifty-three 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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Questions you can ask:
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Summary for AKYNZEO
International Patents: | 193 |
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
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 |
---|---|
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 ⤷ Subscribe.
This potential generic entry date is based on patent 9,951,016.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 8,426,450 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Helsinn Hlthcare | AKYNZEO | fosnetupitant chloride hydrochloride; palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 210493-002 | May 27, 2020 | RX | Yes | Yes | 10,828,297 | ⤷ Subscribe | ⤷ Subscribe | ||||
Helsinn Hlthcare | AKYNZEO | fosnetupitant chloride hydrochloride; palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 210493-002 | May 27, 2020 | RX | Yes | Yes | 10,624,911 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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 | 5,202,333 | ⤷ Subscribe |
Helsinn Hlthcare | AKYNZEO | netupitant; palonosetron hydrochloride | CAPSULE;ORAL | 205718-001 | Oct 10, 2014 | 6,297,375 | ⤷ Subscribe |
>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: ⤷ Subscribe
Australia
Patent: 15323515
Estimated Expiration: ⤷ Subscribe
Patent: 17276588
Patent: Physiologically balanced injectable formulations of fosnetupitant
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2018074655
Patent: formulação injetável de fosnetupitant e método de fabricação de uma formulação
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 60599
Estimated Expiration: ⤷ Subscribe
Patent: 25837
Patent: FORMULATIONS INJECTABLES PHYSIOLOGIQUEMENT EQUILIBREES DE FOSNETUPITANT (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Estimated Expiration: ⤷ Subscribe
Chile
Patent: 18003338
Patent: Formulaciones inyectables fisiológicamente balanceadas de fosnetupitant.
Estimated Expiration: ⤷ Subscribe
China
Patent: 7001275
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Colombia
Patent: 18011686
Patent: Formulaciones inyectables fisiológicamente balanceadas de fosnetupitant
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0200196
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 22755
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 35980
Estimated Expiration: ⤷ Subscribe
Ecuador
Patent: 19000169
Patent: FORMULACIONES INYECTABLES FISIOLÓGICAMENTE BALANCEADAS DE FOSNETUPITANT
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 6605
Patent: ФИЗИОЛОГИЧЕСКИ СБАЛАНСИРОВАННЫЙ СОСТАВ ДЛЯ ИНЪЕКЦИЙ, ВКЛЮЧАЮЩИЙ ФОСНЕТУПИТАНТ (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATION OF FOSNETUPITANT)
Estimated Expiration: ⤷ Subscribe
Patent: 1892837
Patent: ФИЗИОЛОГИЧЕСКИ СБАЛАНСИРОВАННЫЕ СОСТАВЫ ДЛЯ ИНЪЕКЦИЙ, ВКЛЮЧАЮЩИЕ ФОСНЕТУПИТАНТ
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 97871
Estimated Expiration: ⤷ Subscribe
Patent: 35980
Patent: FORMULATIONS INJECTABLES DE FOSNETUPITANT PHYSIOLOGIQUEMENT EQUILIBREES (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Estimated Expiration: ⤷ Subscribe
Patent: 26231
Patent: FORMULATIONS INJECTABLES DE FOSNETUPITANT PHYSIOLOGIQUEMENT ÉQUILIBRÉES (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 3126
Patent: פורמולציות להזרקה של פוסנטופיטנט המאוזנות פיזיולוגית (Physiologically balanced injectable formulations of fosnetupitant)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 36817
Estimated Expiration: ⤷ Subscribe
Patent: 23084
Estimated Expiration: ⤷ Subscribe
Patent: 17529380
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Jordan
Patent: 0170137
Patent: صيغ قابلة للحقن متوازنة فسيولوجياً من فوسنيتوبيتانت (Physiologically balanced injectable formulations of fosnetupitant)
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 35980
Estimated Expiration: ⤷ Subscribe
Malaysia
Patent: 4081
Patent: PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 18015036
Patent: FORMULACIONES INYECTABLES FISIOLOGICAMENTE BALANCEADAS DE FOSNETUPITANT. (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT.)
Estimated Expiration: ⤷ Subscribe
Moldova, Republic of
Patent: 35980
Estimated Expiration: ⤷ Subscribe
Morocco
Patent: 513
Patent: Formulations injectables de fosnetupitant physiologiquement equilibrees
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 7865
Estimated Expiration: ⤷ Subscribe
Peru
Patent: 190347
Patent: FORMULACIONES INYECTABLES FISIOLOGICAMENTE BALANCEADAS DE FOSNETUPITANT
Estimated Expiration: ⤷ Subscribe
Philippines
Patent: 018502524
Patent: PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 35980
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 35980
Estimated Expiration: ⤷ Subscribe
Serbia
Patent: 852
Patent: FIZIOLOŠKI BALANSIRANE INJEKTABILNE FORMULACIJE FOSNETUPITANTA (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 201809708P
Patent: PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 35980
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 1807932
Patent: PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 2459416
Estimated Expiration: ⤷ Subscribe
Patent: 170063768
Patent: NK-1 길항제의 결정질 형태 (-1 CRYSTALLINE FORMS OF AN NK-1 ANTAGONIST)
Estimated Expiration: ⤷ Subscribe
Patent: 190015276
Patent: 포스네투피탄트의 생리학적으로 균형잡힌 주사가능 제제
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 71226
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 25191
Estimated Expiration: ⤷ Subscribe
Patent: 1613888
Patent: Crystalline forms of an NK-1 antagonist
Estimated Expiration: ⤷ Subscribe
Patent: 1801727
Patent: Physiologically balanced injectable formulations of fosnetupitant
Estimated Expiration: ⤷ Subscribe
Ukraine
Patent: 2285
Patent: ФІЗІОЛОГІЧНО ЗБАЛАНСОВАНІ СКЛАДИ ДЛЯ ІН'ЄКЦІЙ, ЯКІ ВКЛЮЧАЮТЬ ФОСНЕТУПІТАНТ (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT)
Estimated Expiration: ⤷ Subscribe
Uruguay
Patent: 273
Patent: FORMULACIONES INYECTABLES FISIOLÓGICAMENTE BALANCEADAS DE FOSNETUPITANT
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Slovenia | 1035115 | ⤷ Subscribe | |
Mexico | 2018015036 | FORMULACIONES INYECTABLES FISIOLOGICAMENTE BALANCEADAS DE FOSNETUPITANT. (PHYSIOLOGICALLY BALANCED INJECTABLE FORMULATIONS OF FOSNETUPITANT.) | ⤷ Subscribe |
China | 1142144 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AKYNZEO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1035115 | 43/2015 | Austria | ⤷ Subscribe | PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
1035115 | 300758 | Netherlands | ⤷ Subscribe | PRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1001 20150527 |
0430190 | SPC/GB05/032 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
AKYNZEO Market Analysis and Financial Projection Experimental
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