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. Akynzeo's patents have been open to challenges since 19 April, 2022. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| 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 |
| 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 |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| 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 |
| 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 |
| US10828297 | Compositions and methods for treating centrally mediated nausea and vomiting |
Dec, 2030
(6 years from now) | Active |
| US9186357 | Compositions and methods for treating centrally mediated nausea and vomiting |
Nov, 2030
(6 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Akynzeo's patents.
Latest Legal Activities on Akynzeo's Patents
Given below is the list of recent legal activities going on the following patents of Akynzeo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Apr, 2024 | US10828297 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Jan, 2024 | US9403772 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Dec, 2023 | US10717721 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Nov, 2023 | US10676440 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Sep, 2023 | US10624911 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Aug, 2023 | US9271975 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2023 | US9186357 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Jan, 2023 | US11559523 |
| Recordation of Patent Grant Mailed Critical | 24 Jan, 2023 | US11559523 |
| Post Issue Communication - Certificate of Correction | 06 Jan, 2023 | US10624911 |
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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 |
Alternative Brands for Akynzeo
Akynzeo which is used for preventing chemotherapy-induced nausea and vomiting in adults., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Helsinn Hlthcare |
| |||
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.
Approval Date:
Akynzeo was approved by FDA for market use on 19 April, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 - solution form for intravenous use, powder 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 |
Akynzeo is a drug owned by Helsinn Healthcare Sa. It is protected by 14 US drug patents filed from 2014 to 2024. Out of these, 12 drug patents are active and 2 have expired. Akynzeo's patents have been open to challenges since 10 October, 2018. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9951016 | Crystalline forms of an NK-1 antagonist |
Sep, 2035
(10 years from now) | Active |
| US10961195 | Crystalline forms of an NK-1 antagonist |
Sep, 2035
(10 years from now) | Active |
| US10676440 | Crystalline forms of an NK-1 antagonist |
Sep, 2035
(10 years from now) | Active |
| US10233154 | Crystalline forms of an NK-1 antagonist |
Sep, 2035
(10 years from now) | Active |
| US6297375 | 4-phenyl-pyridine derivatives |
Mar, 2023
(1 year, 7 months ago) |
Expired
|
| US5202333 | Tricyclic 5-HT3 receptor antagonists |
Apr, 2015
(9 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9271975 | Compositions and methods for treating centrally mediated nausea and vomiting |
Sep, 2031
(6 years from now) | Active |
| US10828297 | Compositions and methods for treating centrally mediated nausea and vomiting |
Dec, 2030
(6 years from now) | Active |
| US12042494 | Compositions and methods for treating centrally mediated nausea and vomiting |
Nov, 2030
(6 years from now) | Active |
| US9943515 | 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 |
| US9186357 | 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 |
| US8951969 | Compositions and methods for treating centrally mediated nausea and vomiting |
Nov, 2030
(6 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Akynzeo's patents.
Latest Legal Activities on Akynzeo's Patents
Given below is the list of recent legal activities going on the following patents of Akynzeo.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Apr, 2024 | US10828297 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Jan, 2024 | US9403772 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Dec, 2023 | US10717721 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Nov, 2023 | US10676440 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Sep, 2023 | US10624911 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Aug, 2023 | US9271975 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2023 | US9186357 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Jan, 2023 | US11559523 |
| Recordation of Patent Grant Mailed Critical | 24 Jan, 2023 | US11559523 |
| Post Issue Communication - Certificate of Correction | 06 Jan, 2023 | US10624911 |
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 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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.
Alternative Brands for Akynzeo
Akynzeo which is used for preventing chemotherapy-induced nausea and vomiting in adults., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Helsinn Hlthcare |
| |||
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.
Approval Date:
Akynzeo was approved by FDA for market use on 10 October, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 |