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Last Updated: August 10, 2020

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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 thirty-eight 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.

US ANDA Litigation and 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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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   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 1490066-6 Sweden   Start Trial PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
2203462 PA2014040,C2203462 Lithuania   Start Trial PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462 14C0082 France   Start Trial PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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