Prevymis is a drug owned by Merck Sharp And Dohme Corp. It is protected by 4 US drug patents filed from 2018 to 2020. Out of these, 2 drug patents are active and 2 have expired. Prevymis's patents have been open to challenges since 08 November, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 28, 2033. Details of Prevymis'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. | |||
| USRE46791 | Substituted dihydroquinazolines |
Jan, 2029
(4 years from now) | Active |
| US7196086 | Substituted dihydroquinazolines |
May, 2024
(6 months ago) |
Expired
|
| US8513255 | Substituted dihydroquinazolines |
May, 2024
(6 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10603384 | Pharmaceutical composition containing an antivirally active dihydroquinazoline derivative |
Feb, 2033
(8 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 Prevymis's patents.
Latest Legal Activities on Prevymis's Patents
Given below is the list of recent legal activities going on the following patents of Prevymis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 01 May, 2024 | US10603384 |
| Mail Patent eCofC Notification | 30 Apr, 2024 | US10603384 |
| Recordation of Patent eCertificate of Correction | 30 Apr, 2024 | US10603384 |
| Patent eCofC Notification | 30 Apr, 2024 | US10603384 |
| Email Notification Critical | 30 Apr, 2024 | US10603384 |
| Post Issue Communication - Certificate of Correction | 10 Apr, 2024 | US10603384 |
| Withdrawal of Application for PTE Critical | 07 Feb, 2024 | US8513255 |
| Election in Response to Notice of Final Determination | 27 Dec, 2023 | US8513255 |
| Notice of Final Determination -Election Required | 14 Dec, 2023 | US8513255 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Sep, 2023 | US10603384 |
FDA has granted several exclusivities to Prevymis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Prevymis, 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 Prevymis.
Exclusivity Information
Prevymis holds 10 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Prevymis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 08, 2022 |
| ODE*(ODE*) | Jun 05, 2030 |
| Orphan Drug Exclusivity(ODE-165) | Nov 08, 2024 |
| New Indication(I-916) | Jun 05, 2026 |
| New Dosing Schedule(D-189) | Aug 02, 2026 |
| New Product(NP) | Aug 30, 2027 |
| New Patient Population(NPP) | Aug 30, 2027 |
| Orphan Drug Exclusivity(ODE-423) | Jun 05, 2030 |
| Orphan Drug Exclusivity(ODE-495) | Aug 30, 2031 |
| Orphan Drug Exclusivity(ODE-497) | Aug 30, 2031 |
US patents provide insights into the exclusivity only within the United States, but Prevymis 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 Prevymis's family patents as well as insights into ongoing legal events on those patents.
Prevymis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Prevymis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 28, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Prevymis Generics:
There are no approved generic versions for Prevymis as of now.
About Prevymis
Prevymis is a drug owned by Merck Sharp And Dohme Corp. Prevymis uses Letermovir as an active ingredient. Prevymis was launched by Merck Sharp Dohme in 2017.
Approval Date:
Prevymis was approved by FDA for market use on 08 November, 2017.
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 Prevymis is 08 November, 2017, its NCE-1 date is estimated to be 08 November, 2021.
Active Ingredient:
Prevymis uses Letermovir as the active ingredient. Check out other Drugs and Companies using Letermovir ingredient
Dosage:
Prevymis is available in the following dosage forms - tablet form for oral use, solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 480MG/24ML (20MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 240MG/12ML (20MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 240MG | TABLET | Prescription | ORAL |
| 480MG | TABLET | Prescription | ORAL |
Prevymis is a drug owned by Merck Sharp And Dohme Llc. It is protected by 1 US drug patent filed in 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 30, 2031. Details of Prevymis'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. | |||
| USRE46791 | Substituted dihydroquinazolines |
Jan, 2029
(4 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 Prevymis's patents.
Latest Legal Activities on Prevymis's Patents
Given below is the list of recent legal activities going on the following patents of Prevymis.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Email Notification Critical | 01 May, 2024 | US10603384 |
| Mail Patent eCofC Notification | 30 Apr, 2024 | US10603384 |
| Recordation of Patent eCertificate of Correction | 30 Apr, 2024 | US10603384 |
| Patent eCofC Notification | 30 Apr, 2024 | US10603384 |
| Email Notification Critical | 30 Apr, 2024 | US10603384 |
| Post Issue Communication - Certificate of Correction | 10 Apr, 2024 | US10603384 |
| Withdrawal of Application for PTE Critical | 07 Feb, 2024 | US8513255 |
| Election in Response to Notice of Final Determination | 27 Dec, 2023 | US8513255 |
| Notice of Final Determination -Election Required | 14 Dec, 2023 | US8513255 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Sep, 2023 | US10603384 |
FDA has granted several exclusivities to Prevymis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Prevymis, 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 Prevymis.
Exclusivity Information
Prevymis holds 10 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Prevymis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 08, 2022 |
| ODE*(ODE*) | Jun 05, 2030 |
| Orphan Drug Exclusivity(ODE-165) | Nov 08, 2024 |
| New Indication(I-916) | Jun 05, 2026 |
| New Dosing Schedule(D-189) | Aug 02, 2026 |
| New Product(NP) | Aug 30, 2027 |
| New Patient Population(NPP) | Aug 30, 2027 |
| Orphan Drug Exclusivity(ODE-423) | Jun 05, 2030 |
| Orphan Drug Exclusivity(ODE-495) | Aug 30, 2031 |
| Orphan Drug Exclusivity(ODE-497) | Aug 30, 2031 |
US patents provide insights into the exclusivity only within the United States, but Prevymis 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 Prevymis's family patents as well as insights into ongoing legal events on those patents.
Prevymis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Prevymis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 30, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Prevymis Generics:
There are no approved generic versions for Prevymis as of now.
About Prevymis
Prevymis is a drug owned by Merck Sharp And Dohme Llc. Prevymis uses Letermovir as an active ingredient. Prevymis was launched by Msd in 2024.
Approval Date:
Prevymis was approved by FDA for market use on 30 August, 2024.
Active Ingredient:
Prevymis uses Letermovir as the active ingredient. Check out other Drugs and Companies using Letermovir ingredient
Dosage:
Prevymis is available in pellets form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG/PACKET | PELLETS | Prescription | ORAL |
| 120MG/PACKET | PELLETS | Prescription | ORAL |