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Details for Patent: 8,889,159

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Patent 8,889,159 protects HARVONI, EPCLUSA, and SOVALDI, and is included in three NDAs.

This patent has fifty-eight patent family members in twenty-seven countries.

Summary for Patent: 8,889,159

Title:Compositions and methods for treating hepatitis C virus
Abstract: Disclosed herein are a composition and unit dosage form for the treatment of hepatitis C virus (HCV) infection comprising GS-7977 and at least one pharmaceutically acceptable excipient, as well as methods for making said composition and unit dosage form. Also disclosed herein is a method of treating a subject, preferably a human, infected with hepatitis C virus, said method comprising administering to the subject for a time period an effective amount of GS-7977 and an effective amount of ribavirin. In one aspect, the method comprises administering to the subject an interferon-free treatment regimen comprising an effective amount of GS-7977 and an effective amount of ribavirin. In a particular aspect, the method is sufficient to produce an undetectable amount of HCV RNA in the subject for at least 12 weeks after the end of the time period.
Inventor(s): Cleary; Darryl G. (Chapel Hill, NC), Reynolds; Charles J. (Greenville, NC), Berrey; Miriam Michelle (Durham, NC), Hindes; Robert G. (Skillman, NJ), Symonds; William T. (San Francisco, CA), Ray; Adrian S. (Redwood City, CA), Mo; Hongmei (Palo Alto, CA), Hebner; Christy M. (Belmont, CA), Oliyai; Reza (Burlingame, CA), Zia; Vahid (San Carlos, CA), Stefanidis; Dimitrios (Mountain View, CA), Pakdaman; Rowchanak (San Carlos, CA), Casteel; Melissa Jean (Burlingame, CA)
Assignee: Gilead Pharmasset LLC (Foster City, CA)
Application Number:13/686,664
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Process; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 2nd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYes8,889,159► subscribeY FOR THE TREATMENT OF HEPATITIS C
Gilead Sciences Inc
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYes8,889,159► subscribeY FOR THE TREATMENT OF HEPATITIS C
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYes8,889,159► subscribeY FOR THE TREATMENT OF HEPATITIS C
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Non-Orange Book Patents for Patent: 8,889,159

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,393,256Methods for treating HCV► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 8,889,159

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Hong Kong1202268► subscribe
Israel231515► subscribe
Israel232889► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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