Verquvo is a drug owned by Merck Sharp And Dohme Corp. It is protected by 6 US drug patents filed from 2021 to 2022 out of which none have expired yet. Verquvo's patents will be open to challenges from 19 January, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 26, 2032. Details of Verquvo'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. | |||
| US9604948 | Process for preparing substituted 5-fluoro-1H-pyrazolopyridines |
Nov, 2032
(8 years from now) | Active |
| US10736896 | Substituted 5-fluoro-1H-pyrazolopyridines and their use |
May, 2031
(6 years from now) | Active |
| US8420656 | Substituted 5-fluoro-1H-pyrazolopyridines and their use |
May, 2031
(6 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). | |||
| US11439642 | Substituted 5-fluoro-1H-pyrazolopyridines and their use |
May, 2031
(6 years from now) | Active |
| US8921377 | Substituted 5-fluoro-1H-pyrazolopyridines and their use |
May, 2031
(6 years from now) | Active |
| US9993476 | Substituted 5-flouro-1H-pyrazolopyridines and their use |
May, 2031
(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 Verquvo's patents.
Latest Legal Activities on Verquvo's Patents
Given below is the list of recent legal activities going on the following patents of Verquvo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Jan, 2024 | US10736896 |
| Second letter to regulating agency to determine regulatory review period | 15 Jun, 2023 | US8420656 |
| Second letter to regulating agency to determine regulatory review period | 15 Jun, 2023 | US9604948 |
| Letter from FDA or Dept of Agriculture re PTE application | 03 Oct, 2022 | US9604948 |
| Letter from FDA or Dept of Agriculture re PTE application | 03 Oct, 2022 | US8420656 |
| Patent Issue Date Used in PTA Calculation Critical | 13 Sep, 2022 | US11439642 |
| Recordation of Patent Grant Mailed Critical | 13 Sep, 2022 | US11439642 |
| Email Notification Critical | 25 Aug, 2022 | US11439642 |
| Issue Notification Mailed Critical | 24 Aug, 2022 | US11439642 |
| Application Is Considered Ready for Issue Critical | 05 Aug, 2022 | US11439642 |
FDA has granted several exclusivities to Verquvo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Verquvo, 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 Verquvo.
Exclusivity Information
Verquvo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Verquvo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 19, 2026 |
US patents provide insights into the exclusivity only within the United States, but Verquvo 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 Verquvo's family patents as well as insights into ongoing legal events on those patents.
Verquvo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Verquvo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 26, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Verquvo Generics:
There are no approved generic versions for Verquvo as of now.
About Verquvo
Verquvo is a drug owned by Merck Sharp And Dohme Corp. It is used for reducing the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure. Verquvo uses Vericiguat as an active ingredient. Verquvo was launched by Merck Sharp Dohme in 2021.
Approval Date:
Verquvo was approved by FDA for market use on 19 January, 2021.
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 Verquvo is 19 January, 2021, its NCE-1 date is estimated to be 19 January, 2025.
Active Ingredient:
Verquvo uses Vericiguat as the active ingredient. Check out other Drugs and Companies using Vericiguat ingredient
Treatment:
Verquvo is used for reducing the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure.
Dosage:
Verquvo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.5MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |