Sovaldi Patent Expiration

Sovaldi is a drug owned by Gilead Sciences Inc. It is protected by 18 US drug patents filed from 2014 to 2019 out of which none have expired yet. Sovaldi's patents have been open to challenges since 08 October, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 11, 2031. Details of Sovaldi'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.
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
US8334270 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).
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
US9549941

(Pediatric)

Compositions and methods for treating hepatitis C virus
Sep, 2029

(4 years from now)

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

(4 years from now)

Active
US9549941 Compositions and methods for treating hepatitis C virus
Mar, 2029

(4 years from now)

Active
US9085573

(Pediatric)

NA
Sep, 2028

(3 years from now)

Active
US8334270

(Pediatric)

NA
Sep, 2028

(3 years from now)

Active
US8580765

(Pediatric)

NA
Sep, 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 Sovaldi's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 10 Jul, 2024 US9549941
Payment of Maintenance Fee, 4th Year, Large Entity 09 Jul, 2020 US9549941
Mail Certificate of Correction Memo 17 Apr, 2018 US9549941
Certificate of Correction Memo 11 Apr, 2018 US9549941
Recordation of Patent Grant Mailed 24 Jan, 2017 US9549941
Patent Issue Date Used in PTA Calculation 24 Jan, 2017 US9549941
Email Notification 05 Jan, 2017 US9549941
Issue Notification Mailed 04 Jan, 2017 US9549941
Application Is Considered Ready for Issue 14 Dec, 2016 US9549941
Dispatch to FDC 14 Dec, 2016 US9549941


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 Sovaldi and ongoing litigations to help you estimate the early arrival of Sovaldi generic.

Sovaldi's Litigations

Sovaldi 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 Sovaldi'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.
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 Sovaldi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sovaldi, 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 Sovaldi.

Exclusivity Information

Sovaldi holds 7 exclusivities out of which 6 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Sovaldi's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 06, 2018
New Patient Population(NPP) Apr 07, 2020
Orphan Drug Exclusivity(ODE) Apr 07, 2024
ODE*(ODE*) Aug 28, 2026
Orphan Drug Exclusivity(ODE-135) Apr 07, 2024
Pediatric Exclusivity(PED) Oct 07, 2024
Orphan Drug Exclusivity(ODE-258) Aug 28, 2026

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Several oppositions have been filed on Sovaldi'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 Sovaldi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Sovaldi patents.

Sovaldi's Oppositions Filed in EPO

Sovaldi 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 Sovaldi 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 Sovaldi's family patents as well as insights into ongoing legal events on those patents.

Sovaldi's Family Patents

Sovaldi has patent protection in a total of 47 countries. It's US patent count contributes only to 15.5% of its total global patent coverage. 4 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 Sovaldi.

Family Patents

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Generic Launch

Generic Release Date:

Sovaldi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 11, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Sovaldi Generics:

Sofosbuvir is the generic name for the brand Sovaldi. 1 company has already filed for the generic of Sovaldi. Check out the entire list of companies who have already received approval for Sovaldi's generic

How can I launch a generic of Sovaldi before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Sovaldi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sovaldi'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 Sovaldi -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
400 mg 06 Dec, 2017 2 27 Jan, 2022 11 Dec, 2030 Deferred

Alternative Brands for Sovaldi

Sovaldi which is used for treating chronic hepatitis C virus infection as part of combination antiviral therapy., has several other brand drugs in the same treatment category and using the same active ingredient (Sofosbuvir). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Gilead Sciences Inc
Epclusa

(uses Sofosbuvir)

Used for treating hepatitis C.
Harvoni

(uses Sofosbuvir)

Used for treating chronic Hepatitis C virus (HCV) infection in treatment-naive genotype 1 patients for an 8-week duration.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Sofosbuvir. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Gilead Sciences Inc
Vosevi


Apart from brand drugs containing the same ingredient, some generics have also been filed for Sofosbuvir, Sovaldi's active ingredient. Check the complete list of approved generic manufacturers for Sovaldi





About Sovaldi

Sovaldi is a drug owned by Gilead Sciences Inc. It is used for treating chronic hepatitis C virus infection as part of combination antiviral therapy. Sovaldi uses Sofosbuvir as an active ingredient. Sovaldi was launched by Gilead Sciences Inc in 2019.

Approval Date:

Sovaldi was approved by FDA for market use on 28 August, 2019.

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 Sovaldi is 28 August, 2019, its NCE-1 date is estimated to be 08 October, 2023.

Active Ingredient:

Sovaldi uses Sofosbuvir as the active ingredient. Check out other Drugs and Companies using Sofosbuvir ingredient

Treatment:

Sovaldi is used for treating chronic hepatitis C virus infection as part of combination antiviral therapy.

Dosage:

Sovaldi is available in the following dosage forms - tablet form for oral use, pellets form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
400MG TABLET Prescription ORAL
150MG/PACKET PELLETS Prescription ORAL
200MG/PACKET PELLETS Prescription ORAL
200MG TABLET Prescription ORAL