Emend is a drug owned by Merck And Co Inc. It is protected by 6 US drug patents filed from 2013 to 2018 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 02, 2025. Details of Emend's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7214692 | Medical use for tachykinin antagonists |
Sep, 2012
(11 years ago) |
Expired
|
| US5538982 | Medical use for tachykinin antagonists |
Jul, 2013
(11 years ago) |
Expired
|
| US5512570 | Treatment of emesis with morpholine tachykinin receptor antagonists |
Mar, 2014
(10 years ago) |
Expired
|
| US5716942 | Treatment of migraine with morpholine tachykinin receptor antagonists |
Feb, 2015
(9 years ago) |
Expired
|
| US5691336 | Morpholine compounds are prodrugs useful as tachykinin receptor antagonists |
Mar, 2019
(5 years ago) |
Expired
|
|
US5691336 (Pediatric) | Morpholine compounds are prodrugs useful as tachykinin receptor antagonists |
Sep, 2019
(4 years ago) |
Expired
|
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 Emend's patents.
Latest Legal Activities on Emend's Patents
Given below is the list of recent legal activities going on the following patents of Emend.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Feb, 2024 | US8258132 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Feb, 2020 | US8258132 |
| Expire Patent | 05 Jun, 2015 | US7214692 |
| Recordation of Patent Grant Mailed | 04 Sep, 2012 | US8258132 |
| Patent Issue Date Used in PTA Calculation | 04 Sep, 2012 | US8258132 |
| Issue Notification Mailed | 15 Aug, 2012 | US8258132 |
| Application Is Considered Ready for Issue | 01 Aug, 2012 | US8258132 |
| Dispatch to FDC | 01 Aug, 2012 | US8258132 |
| Issue Fee Payment Received | 30 Jul, 2012 | US8258132 |
| Issue Fee Payment Verified | 30 Jul, 2012 | US8258132 |
FDA has granted several exclusivities to Emend. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Emend, 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 Emend.
Exclusivity Information
Emend holds 6 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Emend's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 25, 2013 |
| New Dosing Schedule(D-128) | Nov 12, 2013 |
| New Dosing Schedule(D-155) | Feb 01, 2019 |
| New Patient Population(NPP) | Apr 03, 2021 |
| Pediatric Exclusivity(PED) | Oct 03, 2021 |
| New Dosing Schedule(D-186) | May 02, 2025 |
US patents provide insights into the exclusivity only within the United States, but Emend 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 Emend's family patents as well as insights into ongoing legal events on those patents.
Emend's family patents
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Generic Launch
Generic Release Date:
Emend's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 02, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Emend Generics:
Fosaprepitant Dimeglumine is the generic name for the brand Emend. 3 different companies have already filed for the generic of Emend, with Glenmark Speclt having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Emend's generic
How can I launch a generic of Emend before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Emend's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Emend'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 Emend -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 115 mg/vial | 25 Jan, 2012 | 1 | 05 Sep, 2019 | 10 Feb, 2015 | Extinguished |
| 150 mg/vial | 25 Jan, 2012 | 2 | 04 Mar, 2019 | Extinguished |
About Emend
Emend is a drug owned by Merck And Co Inc. It is used for preventing and treating nausea and vomiting associated with chemotherapy, postoperative nausea and vomiting, and emesis induced by cancer chemotherapeutic agents. Emend uses Fosaprepitant Dimeglumine as an active ingredient. Emend was launched by Merck And Co Inc in 2008.
Market Authorisation Date:
Emend was approved by FDA for market use on 25 January, 2008.
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 Emend is 25 January, 2008, its NCE-1 date is estimated to be 03 October, 2020
Active Ingredient:
Emend uses Fosaprepitant Dimeglumine as the active ingredient. Check out other Drugs and Companies using Fosaprepitant Dimeglumine ingredient
Treatment:
Emend is used for preventing and treating nausea and vomiting associated with chemotherapy, postoperative nausea and vomiting, and emesis induced by cancer chemotherapeutic agents.
Dosage:
Emend is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER | Discontinued | INTRAVENOUS |
| EQ 150MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |
Emend is a drug owned by Merck And Co Inc. It is protected by 5 US drug patents filed in 2013. Out of these, 1 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 26, 2027. Details of Emend's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7214692 | Medical use for tachykinin antagonists |
Sep, 2012
(11 years ago) |
Expired
|
| US5538982 | Medical use for tachykinin antagonists |
Jul, 2013
(11 years ago) |
Expired
|
| US5719147 | Morpholine and thiomorpholine tachykinin receptor antagonists |
Apr, 2015
(9 years ago) |
Expired
|
| US6096742 | Polymorphic form of a tachykinin receptor antagonist |
Jul, 2018
(6 years ago) |
Expired
|
| US8258132 | Pharmaceutical composition of a tachykinin receptor antagonist |
Sep, 2027
(3 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 Emend's patents.
Latest Legal Activities on Emend's Patents
Given below is the list of recent legal activities going on the following patents of Emend.
| Event | Date | Patent/Publication |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Feb, 2024 | US8258132 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Feb, 2020 | US8258132 |
| Expire Patent | 05 Jun, 2015 | US7214692 |
| Recordation of Patent Grant Mailed | 04 Sep, 2012 | US8258132 |
| Patent Issue Date Used in PTA Calculation | 04 Sep, 2012 | US8258132 |
| Issue Notification Mailed | 15 Aug, 2012 | US8258132 |
| Application Is Considered Ready for Issue | 01 Aug, 2012 | US8258132 |
| Dispatch to FDC | 01 Aug, 2012 | US8258132 |
| Issue Fee Payment Received | 30 Jul, 2012 | US8258132 |
| Issue Fee Payment Verified | 30 Jul, 2012 | US8258132 |
FDA has granted several exclusivities to Emend. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Emend, 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 Emend.
Exclusivity Information
Emend holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Emend's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-82) | Mar 19, 2013 |
| New Patient Population(NPP) | Aug 28, 2018 |
Several oppositions have been filed on Emend'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 Emend's generic, the next section provides detailed information on ongoing and past EP oppositions related to Emend patents.
Emend's oppositions filed in EPO
Emend has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 06, 2009, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP02796109A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP02796109A | Apr, 2009 | Hexal AG | Patent maintained as amended |
| EP02796109A | Apr, 2009 | Teva Pharmaceutical Industries Ltd. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Emend 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 Emend's family patents as well as insights into ongoing legal events on those patents.
Emend's family patents
Coming Soon
Patent Strength Analyzer
YesNo
Thank you for your response 🥳
Generic Launch
Generic Release Date:
Emend's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 26, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Emend Generics:
Aprepitant is the generic name for the brand Emend. 3 different companies have already filed for the generic of Emend, with Glenmark Speclt having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Emend's generic
How can I launch a generic of Emend before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Emend's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Emend'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 Emend -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg, 80 mg and 125 mg | 03 Nov, 2008 | 1 | 24 Sep, 2012 | 17 Apr, 2015 | Deferred |
| 125 mg/Kit | 23 Nov, 2016 | 1 | 26 Sep, 2027 | Extinguished |
About Emend
Emend is a drug owned by Merck And Co Inc. It is used for preventing and treating nausea and vomiting associated with chemotherapy, postoperative nausea and vomiting, and emesis induced by cancer chemotherapeutic agents. Emend uses Aprepitant as an active ingredient. Emend was launched by Merck in 2006.
Market Authorisation Date:
Emend was approved by FDA for market use on 30 June, 2006.
Active Ingredient:
Emend uses Aprepitant as the active ingredient. Check out other Drugs and Companies using Aprepitant ingredient
Treatment:
Emend is used for preventing and treating nausea and vomiting associated with chemotherapy, postoperative nausea and vomiting, and emesis induced by cancer chemotherapeutic agents.
Dosage:
Emend is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| 125MG | CAPSULE | Prescription | ORAL |
| 80MG | CAPSULE | Prescription | ORAL |
Emend is a drug owned by Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc. It is protected by 2 US drug patents filed in 2016. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 26, 2027. Details of Emend'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. | |||
| US6096742 | Polymorphic form of a tachykinin receptor antagonist |
Jul, 2018
(6 years ago) |
Expired
|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8258132 | Pharmaceutical composition of a tachykinin receptor antagonist |
Sep, 2027
(3 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 Emend's patents.
Latest Legal Activities on Emend's Patents
Given below is the list of recent legal activities going on the following patents of Emend.
| Event | Date | Patent/Publication |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Feb, 2024 | US8258132 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Feb, 2020 | US8258132 |
| Expire Patent | 05 Jun, 2015 | US7214692 |
| Recordation of Patent Grant Mailed | 04 Sep, 2012 | US8258132 |
| Patent Issue Date Used in PTA Calculation | 04 Sep, 2012 | US8258132 |
| Issue Notification Mailed | 15 Aug, 2012 | US8258132 |
| Application Is Considered Ready for Issue | 01 Aug, 2012 | US8258132 |
| Dispatch to FDC | 01 Aug, 2012 | US8258132 |
| Issue Fee Payment Received | 30 Jul, 2012 | US8258132 |
| Issue Fee Payment Verified | 30 Jul, 2012 | US8258132 |
FDA has granted several exclusivities to Emend. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Emend, 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 Emend.
Exclusivity Information
Emend holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Emend's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Aug 28, 2018 |
Several oppositions have been filed on Emend'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 Emend's generic, the next section provides detailed information on ongoing and past EP oppositions related to Emend patents.
Emend's oppositions filed in EPO
Emend has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 06, 2009, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP02796109A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP02796109A | Apr, 2009 | Hexal AG | Patent maintained as amended |
| EP02796109A | Apr, 2009 | Teva Pharmaceutical Industries Ltd. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Emend 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 Emend's family patents as well as insights into ongoing legal events on those patents.
Emend's family patents
Coming Soon
Patent Strength Analyzer
YesNo
Thank you for your response 🥳
Generic Launch
Generic Release Date:
Emend's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 26, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Emend Generics:
Aprepitant is the generic name for the brand Emend. 3 different companies have already filed for the generic of Emend, with Glenmark Speclt having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Emend's generic
How can I launch a generic of Emend before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Emend's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Emend'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 Emend -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg, 80 mg and 125 mg | 03 Nov, 2008 | 1 | 24 Sep, 2012 | 17 Apr, 2015 | Deferred |
| 125 mg/Kit | 23 Nov, 2016 | 1 | 26 Sep, 2027 | Extinguished |
About Emend
Emend is a drug owned by Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc. It is used for preventing and treating nausea and vomiting associated with chemotherapy, postoperative nausea and vomiting, and emesis induced by cancer chemotherapeutic agents. Emend uses Aprepitant as an active ingredient. Emend was launched by Msd Merck Co in 2015.
Market Authorisation Date:
Emend was approved by FDA for market use on 17 December, 2015.
Active Ingredient:
Emend uses Aprepitant as the active ingredient. Check out other Drugs and Companies using Aprepitant ingredient
Treatment:
Emend is used for preventing and treating nausea and vomiting associated with chemotherapy, postoperative nausea and vomiting, and emesis induced by cancer chemotherapeutic agents.
Dosage:
Emend is available in for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 125MG/KIT | FOR SUSPENSION | Prescription | ORAL |