Vosevi Patent Expiration

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
US8575135 Antiviral compounds
Nov, 2032

(8 years from now)

Active
US8940718 Antiviral compounds
Nov, 2032

(8 years from now)

Active
US8921341 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
US8889159 Compositions and methods for treating hepatitis C virus
Mar, 2029

(4 years from now)

Active
US7964580 NA
Mar, 2029

(4 years from now)

Active
US8633309 Nucleoside phosphoramidates
Mar, 2029

(4 years from now)

Active
US9585906 NA
Mar, 2028

(3 years from now)

Active
US8580765 NA
Mar, 2028

(3 years from now)

Active
US9085573 NA
Mar, 2028

(3 years from now)

Active
US8334270 NA
Mar, 2028

(3 years from now)

Active
US8735372 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
US11338007 Combination formulation of three antiviral compounds
Jun, 2037

(12 years from now)

Active
US10912814 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
US8575135

(Pediatric)

Antiviral compounds
May, 2033

(8 years from now)

Active
US8921341

(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
US8633309

(Pediatric)

Nucleoside phosphoramidates
Sep, 2029

(4 years from now)

Active
US7964580

(Pediatric)

NA
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.

Given below is the list of recent legal activities going on the following patents of Vosevi.

Activity Date Patent Number
Patent litigations
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 24 May, 2022 US11338007
Patent Issue Date Used in PTA Calculation 24 May, 2022 US11338007
Email Notification 05 May, 2022 US11338007
Issue Notification Mailed 04 May, 2022 US11338007
Email Notification 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.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

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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
Patent litigations
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

Vosevi has patent protection in a total of 48 countries. It's US patent count contributes only to 16.5% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Vosevi.

Family Patents

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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