Akynzeo Patent Expiration

Akynzeo is a drug owned by Helsinn Healthcare Sa. It is protected by 13 US drug patents filed from 2014 to 2023. Out of these, 11 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 25, 2035. Details of Akynzeo's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5202333 Tricyclic 5-HT3 receptor antagonists
Apr, 2015

(9 years ago)

Expired
US6297375 4-phenyl-pyridine derivatives
Mar, 2023

(1 year, 4 months ago)

Expired
US10676440 Crystalline forms of an NK-1 antagonist
Sep, 2035

(11 years from now)

Active
US9951016 Crystalline forms of an NK-1 antagonist
Sep, 2035

(11 years from now)

Active
US10233154 Crystalline forms of an NK-1 antagonist
Sep, 2035

(11 years from now)

Active
US10961195 Crystalline forms of an NK-1 antagonist
Sep, 2035

(11 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9943515 Compositions and methods for treating centrally mediated nausea and vomiting
Nov, 2030

(6 years from now)

Active
US9186357 Compositions and methods for treating centrally mediated nausea and vomiting
Nov, 2030

(6 years from now)

Active
US8951969 Compositions and methods for treating centrally mediated nausea and vomiting
Nov, 2030

(6 years from now)

Active
US11559523 Compositions and methods for treating centrally mediated nausea and vomiting
Nov, 2030

(6 years from now)

Active
US8623826 Compositions and methods for treating centrally mediated nausea and vomiting
Nov, 2030

(6 years from now)

Active
US10828297 Compositions and methods for treating centrally mediated nausea and vomiting
Dec, 2030

(6 years from now)

Active
US9271975 Compositions and methods for treating centrally mediated nausea and vomiting
Sep, 2031

(7 years from now)

Active


FDA has granted several exclusivities to Akynzeo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Akynzeo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Akynzeo.

Exclusivity Information

Akynzeo holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Akynzeo's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Oct 10, 2019

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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Several oppositions have been filed on Akynzeo's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Akynzeo's generic, the next section provides detailed information on ongoing and past EP oppositions related to Akynzeo patents.

Akynzeo's oppositions filed in EPO

Akynzeo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 20, 2016, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP14151676A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP14151676A Jul, 2016 Teva Pharmaceutical Industries Ltd Opposition rejected


US patents provide insights into the exclusivity only within the United States, but Akynzeo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Akynzeo's family patents as well as insights into ongoing legal events on those patents.

Akynzeo's family patents

Akynzeo has patent protection in a total of 42 countries. It's US patent count contributes only to 19.3% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Akynzeo.

Family Patents

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Generic Launch

Generic Release Date:

Akynzeo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 25, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Akynzeo Generics:

There are no approved generic versions for Akynzeo as of now.





About Akynzeo

Akynzeo is a drug owned by Helsinn Healthcare Sa. It is used for preventing chemotherapy-induced nausea and vomiting in adults. Akynzeo uses Netupitant; Palonosetron Hydrochloride as an active ingredient. Akynzeo was launched by Helsinn Hlthcare in 2014.

Market Authorisation Date:

Akynzeo was approved by FDA for market use on 10 October, 2014.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Akynzeo is 10 October, 2014, its NCE-1 date is estimated to be 10 October, 2018

Active Ingredient:

Akynzeo uses Netupitant; Palonosetron Hydrochloride as the active ingredient. Check out other Drugs and Companies using Netupitant; Palonosetron Hydrochloride ingredient

Treatment:

Akynzeo is used for preventing chemotherapy-induced nausea and vomiting in adults.

Dosage:

Akynzeo is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
300MG;EQ 0.5MG BASE CAPSULE Prescription ORAL


Akynzeo is a drug owned by Helsinn Healthcare Sa. It is protected by 11 US drug patents filed from 2018 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 02, 2037. Details of Akynzeo's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9403772 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tolyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium as a neurokinin receptor modulator
May, 2032

(7 years from now)

Active
US11312698 Fosnetupitant chloride hydrochloride having improved stability
May, 2032

(7 years from now)

Active
US8426450 Substituted 4-phenyl pyridines having anti-emetic effect
May, 2032

(7 years from now)

Active
US9908907 Substituted piperaziniums for the treatment of emesis
May, 2032

(7 years from now)

Active
US10717721 Substituted piperaziniums for the treatment of emesis
May, 2032

(7 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9186357 Compositions and methods for treating centrally mediated nausea and vomiting
Nov, 2030

(6 years from now)

Active
US10828297 Compositions and methods for treating centrally mediated nausea and vomiting
Dec, 2030

(6 years from now)

Active
US10208073 Solution comprising the chloride hydrochloride salt of 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tolyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-IUM-(fosnetupitant) and palonosetron hydrochloride in combination with dexamethasone as a neurokinin receptor modulator
May, 2032

(7 years from now)

Active
US8895586 Methods of treating emesis
May, 2032

(7 years from now)

Active
US10624911 Physiologically balanced injectable formulations of fosnetupitant
Jun, 2037

(12 years from now)

Active
US11529362 Physiologically balanced injectable formulations of fosnetupitant
Jun, 2037

(12 years from now)

Active


FDA has granted several exclusivities to Akynzeo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Akynzeo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Akynzeo.

Exclusivity Information

Akynzeo holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Akynzeo's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Apr 19, 2023

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

Several oppositions have been filed on Akynzeo's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Akynzeo's generic, the next section provides detailed information on ongoing and past EP oppositions related to Akynzeo patents.

Akynzeo's oppositions filed in EPO

Akynzeo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 20, 2016, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP14151676A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP14151676A Jul, 2016 Teva Pharmaceutical Industries Ltd Opposition rejected


US patents provide insights into the exclusivity only within the United States, but Akynzeo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Akynzeo's family patents as well as insights into ongoing legal events on those patents.

Akynzeo's family patents

Akynzeo has patent protection in a total of 50 countries. It's US patent count contributes only to 13.9% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Akynzeo.

Family Patents

Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

Thank you for your response 🥳



Generic Launch

Generic Release Date:

Akynzeo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 02, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Akynzeo Generics:

There are no approved generic versions for Akynzeo as of now.

How can I launch a generic of Akynzeo before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Akynzeo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Akynzeo's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Akynzeo -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
235 mg/0.25 mg per 20 mL 19 Apr, 2022 1 02 Jun, 2037




About Akynzeo

Akynzeo is a drug owned by Helsinn Healthcare Sa. It is used for preventing chemotherapy-induced nausea and vomiting in adults. Akynzeo uses Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride as an active ingredient. Akynzeo was launched by Helsinn Hlthcare in 2018.

Market Authorisation Date:

Akynzeo was approved by FDA for market use on 19 April, 2018.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Akynzeo is 19 April, 2018, its NCE-1 date is estimated to be 19 April, 2022

Active Ingredient:

Akynzeo uses Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride as the active ingredient. Check out other Drugs and Companies using Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride ingredient

Treatment:

Akynzeo is used for preventing chemotherapy-induced nausea and vomiting in adults.

Dosage:

Akynzeo is available in the following dosage forms - powder form for intravenous use, solution form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL POWDER Discontinued INTRAVENOUS
EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) SOLUTION Prescription INTRAVENOUS