Vosevi is a drug owned by Gilead Sciences Inc. It is protected by 33 US drug patents filed from 2017 to 2022 out of which none have expired yet. Vosevi's patents have been open to challenges since 18 July, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 01, 2037. Details of Vosevi'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. | |||
| US9296782 | Inhibitors of hepatitis C virus |
Jul, 2034
(9 years from now) | Active |
| US9868745 | Antiviral compounds |
Nov, 2032
(8 years from now) | Active |
| US8921341 | Antiviral compounds |
Nov, 2032
(8 years from now) | Active |
| US8575135 | Antiviral compounds |
Nov, 2032
(8 years from now) | Active |
| US8940718 | Antiviral compounds |
Nov, 2032
(8 years from now) | Active |
| US8618076 | Nucleoside phosphoramidates |
Dec, 2030
(6 years from now) | Active |
| US9284342 | Nucleoside phosphoramidates |
Sep, 2030
(5 years from now) | Active |
| US7964580 | NA |
Mar, 2029
(4 years from now) | Active |
| US8633309 | Nucleoside phosphoramidates |
Mar, 2029
(4 years from now) | Active |
| US8889159 | Compositions and methods for treating hepatitis C virus |
Mar, 2029
(4 years from now) | Active |
| US8334270 | NA |
Mar, 2028
(3 years from now) | Active |
| US8735372 | NA |
Mar, 2028
(3 years from now) | Active |
| US9585906 | NA |
Mar, 2028
(3 years from now) | Active |
| US9085573 | NA |
Mar, 2028
(3 years from now) | Active |
| US8580765 | NA |
Mar, 2028
(3 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). | |||
|
US11338007 (Pediatric) | Combination formulation of three antiviral compounds |
Dec, 2037
(13 years from now) | Active |
| US10912814 | Combination formulation of three antiviral compounds |
Jun, 2037
(12 years from now) | Active |
| US11338007 | Combination formulation of three antiviral compounds |
Jun, 2037
(12 years from now) | Active |
|
US11116783 (Pediatric) | Combination formulation of two antiviral compounds |
Jul, 2034
(9 years from now) | Active |
| US11116783 | Combination formulation of two antiviral compounds |
Jan, 2034
(9 years from now) | Active |
|
US8921341 (Pediatric) | Antiviral compounds |
May, 2033
(8 years from now) | Active |
|
US8575135 (Pediatric) | Antiviral compounds |
May, 2033
(8 years from now) | Active |
|
US8940718 (Pediatric) | Antiviral compounds |
May, 2033
(8 years from now) | Active |
|
US8618076 (Pediatric) | Nucleoside phosphoramidates |
Jun, 2031
(6 years from now) | Active |
|
US9284342 (Pediatric) | Nucleoside phosphoramidates |
Mar, 2031
(6 years from now) | Active |
|
US8889159 (Pediatric) | Compositions and methods for treating hepatitis C virus |
Sep, 2029
(4 years from now) | Active |
|
US7964580 (Pediatric) | NA |
Sep, 2029
(4 years from now) | Active |
|
US8633309 (Pediatric) | Nucleoside phosphoramidates |
Sep, 2029
(4 years from now) | Active |
|
US8580765 (Pediatric) | NA |
Sep, 2028
(3 years from now) | Active |
|
US8334270 (Pediatric) | NA |
Sep, 2028
(3 years from now) | Active |
|
US8735372 (Pediatric) | NA |
Sep, 2028
(3 years from now) | Active |
|
US9085573 (Pediatric) | NA |
Sep, 2028
(3 years from now) | Active |
| US8957046 | NA |
Mar, 2028
(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 Vosevi's patents.
Latest Legal Activities on Vosevi's Patents
Given below is the list of recent legal activities going on the following patents of Vosevi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Sep, 2023 | US9296782 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Aug, 2022 | US8957046 |
| Post Issue Communication - Certificate of Correction | 21 Jun, 2022 | US11338007 |
| Recordation of Patent Grant Mailed Critical | 24 May, 2022 | US11338007 |
| Patent Issue Date Used in PTA Calculation Critical | 24 May, 2022 | US11338007 |
| Email Notification Critical | 05 May, 2022 | US11338007 |
| Issue Notification Mailed Critical | 04 May, 2022 | US11338007 |
| Email Notification Critical | 28 Apr, 2022 | US11338007 |
| Mailing Corrected Notice of Allowability | 28 Apr, 2022 | US11338007 |
| Corrected Notice of Allowability | 22 Apr, 2022 | US11338007 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Vosevi and ongoing litigations to help you estimate the early arrival of Vosevi generic.
Vosevi's Litigations
Vosevi been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 25, 2017, against patent number US7964580. The petitioner Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al., challenged the validity of this patent, with Gilead Pharmasset LLC et al. as the respondent. Click below to track the latest information on how companies are challenging Vosevi's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8889159 | December, 2017 |
Terminated-Denied
(19 Jul, 2018) | Gilead Pharmasset LLC | Initiative for Medicines, Access & Knowledge (I-MAK), Inc. |
| US8735372 | November, 2017 |
Institution Denied
(13 Jun, 2018) | Gilead Pharmasset LLC et al. | Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al. |
| US8633309 | October, 2017 |
Institution Denied
(24 May, 2018) | Gilead Pharmasset LLC | Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al. |
| US9284342 | November, 2017 |
Institution Denied
(24 May, 2018) | Gilead Pharmasset LLC | Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al. |
| US8334270 | October, 2017 |
Institution Denied
(21 May, 2018) | Gilead Pharmasset LLC et al. | Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al. |
| US7964580 | October, 2017 |
Institution Denied
(04 May, 2018) | Gilead Pharmasset LLC et al. | Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al. |
FDA has granted some exclusivities to Vosevi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vosevi, 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 Vosevi.
Exclusivity Information
Vosevi holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Vosevi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 18, 2022 |
Several oppositions have been filed on Vosevi'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 Vosevi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vosevi patents.
Vosevi's Oppositions Filed in EPO
Vosevi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 10, 2015, by Medecins Du Monde. This opposition was filed on patent number EP08732818A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP12768967A | Aug, 2018 | Gillard, Richard Edward | Patent maintained as amended |
| EP08732818A | Feb, 2015 | Actavis Group PTC ehf | Granted and Under Opposition |
| EP08732818A | Feb, 2015 | Intellectual Property Services (IPS) | Granted and Under Opposition |
| EP08732818A | Feb, 2015 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP08732818A | Feb, 2015 | ZBM Patents - Zea, Barlocci & Markvardsen | Granted and Under Opposition |
| EP08732818A | Feb, 2015 | Generics [UK] Ltd (trading as Mylan) | Granted and Under Opposition |
| EP08732818A | Feb, 2015 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP08732818A | Feb, 2015 | Pharmaceutical Works POLPHARMA | Granted and Under Opposition |
| EP08732818A | Feb, 2015 | Fleischer, Holm Herbert | Granted and Under Opposition |
| EP08732818A | Feb, 2015 | ELLIS IP LTD | Granted and Under Opposition |
| EP08732818A | Feb, 2015 | MEDECINS DU MONDE | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Vosevi 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 Vosevi's family patents as well as insights into ongoing legal events on those patents.
Vosevi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vosevi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 01, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vosevi Generics:
There are no approved generic versions for Vosevi as of now.
About Vosevi
Vosevi is a drug owned by Gilead Sciences Inc. It is used for treating chronic HCV infection in adults who have been previously treated with specific medications. Vosevi uses Sofosbuvir; Velpatasvir; Voxilaprevir as an active ingredient. Vosevi was launched by Gilead Sciences Inc in 2017.
Approval Date:
Vosevi was approved by FDA for market use on 18 July, 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 Vosevi is 18 July, 2017, its NCE-1 date is estimated to be 18 July, 2021.
Active Ingredient:
Vosevi uses Sofosbuvir; Velpatasvir; Voxilaprevir as the active ingredient. Check out other Drugs and Companies using Sofosbuvir; Velpatasvir; Voxilaprevir ingredient
Treatment:
Vosevi is used for treating chronic HCV infection in adults who have been previously treated with specific medications.
Dosage:
Vosevi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 400MG;100MG;100MG | TABLET | Prescription | ORAL |