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Last Updated: May 7, 2021

DrugPatentWatch Database Preview

SOVALDI Drug Profile

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When do Sovaldi patents expire, and what generic alternatives are available?

Sovaldi is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and forty-four patent family members in forty-seven countries.

The generic ingredient in SOVALDI is sofosbuvir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir profile page.

DrugPatentWatch® Generic Entry Outlook for Sovaldi

Sovaldi was eligible for patent challenges on December 6, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 11, 2031. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for SOVALDI
Drug Prices for SOVALDI

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for SOVALDI
Generic Entry Dates for SOVALDI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
PELLETS;ORAL
Generic Entry Dates for SOVALDI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SOVALDI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assiut UniversityEarly Phase 1
Ginkgopharma CO., LTDPhase 2
Ginkgopharma CO., LTDPhase 3

See all SOVALDI clinical trials

Paragraph IV (Patent) Challenges for SOVALDI
Tradename Dosage Ingredient NDA Submissiondate
SOVALDI TABLET;ORAL sofosbuvir 204671 2017-12-06

US Patents and Regulatory Information for SOVALDI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead Sciences Inc SOVALDI sofosbuvir PELLETS;ORAL 212480-001 Aug 28, 2019 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead Sciences Inc SOVALDI sofosbuvir PELLETS;ORAL 212480-002 Aug 28, 2019 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-002 Aug 28, 2019 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for SOVALDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 PA2014040,C2203462 Lithuania   Get Started for $10 PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462 PA2014040 Lithuania   Get Started for $10 PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462 67/2014 Austria   Get Started for $10 PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462 CR 2014 00061 Denmark   Get Started for $10 PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117
2203462 C300704 Netherlands   Get Started for $10 PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 2014029 Norway   Get Started for $10 PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
2203462 122014000108 Germany   Get Started for $10 PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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