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Citi
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Generated: December 18, 2017

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AKYNZEO Drug Profile

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When do Akynzeo patents expire, and what generic alternatives are available?

Akynzeo is a drug marketed by Helsinn Hlthcare and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and forty-two patent family members in sixty-three countries and twelve supplementary protection certificates in nine countries.

The generic ingredient in AKYNZEO is netupitant; palonosetron hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the netupitant; palonosetron hydrochloride profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Helsinn HlthcareAKYNZEOnetupitant; palonosetron hydrochlorideCAPSULE;ORAL205718-001Oct 10, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Helsinn HlthcareAKYNZEOnetupitant; palonosetron hydrochlorideCAPSULE;ORAL205718-001Oct 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Helsinn HlthcareAKYNZEOnetupitant; palonosetron hydrochlorideCAPSULE;ORAL205718-001Oct 10, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Helsinn HlthcareAKYNZEOnetupitant; palonosetron hydrochlorideCAPSULE;ORAL205718-001Oct 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Helsinn HlthcareAKYNZEOnetupitant; palonosetron hydrochlorideCAPSULE;ORAL205718-001Oct 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Helsinn HlthcareAKYNZEOnetupitant; palonosetron hydrochlorideCAPSULE;ORAL205718-001Oct 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: AKYNZEO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,479,483 4-phenyl-pyridine derivatives► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: AKYNZEO

Country Document Number Estimated Expiration
Germany60014216► Subscribe
Spain2623503► Subscribe
Morocco26722► Subscribe
CroatiaP20161277► Subscribe
China104856998► Subscribe
CroatiaP20000097► Subscribe
Cyprus1118062► Subscribe
Ukraine105817► Subscribe
Hong Kong1031223► Subscribe
African Intellectual Property Organization (OAPI)11680► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AKYNZEO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
15/030Ireland► SubscribePRODUCT NAME: NETUPITANT OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1001 20150527
00758Netherlands► SubscribePRODUCT NAME: NETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/15/1001 20150527
2015036Lithuania► SubscribePRODUCT NAME: NETUPITANTUM; REGISTRATION NO/DATE: EU/1/15/1001 20150527
1035115/01Switzerland► SubscribePRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: SWISSMEDIC 65499 06.11.2015
2015036,C1035115Lithuania► SubscribePRODUCT NAME: NETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20150527
/2015Austria► SubscribePRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: EU/1/15/1001 20150527
C0049France► SubscribePRODUCT NAME: NETUPITANT OU L'UN DE SES SELS D'ADDITION D'ACIDES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1001 20150529
745Luxembourg► SubscribePRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527
2015 00044Denmark► SubscribePRODUCT NAME: NETUPITANT; REG. NO/DATE: EU/1/15/1001 20150529
90040-0Sweden► SubscribePRODUCT NAME: NETUPITANT; REG. NO/DATE: EU/1/15/1001 20150529
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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Cerilliant
US Army
Citi
Healthtrust
Cipla
Novartis
Johnson and Johnson
US Department of Justice

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 verifification 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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