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Last Updated: March 14, 2025

Details for Patent: 10,086,011


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Which drugs does patent 10,086,011 protect, and when does it expire?

Patent 10,086,011 protects EPCLUSA and is included in one NDA.

Protection for EPCLUSA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-two patent family members in nineteen countries.

Summary for Patent: 10,086,011
Title:Combination formulation of two antiviral compounds
Abstract: Disclosed are pharmaceutical compositions comprising Compound I, having the formula: ##STR00001## and an effective amount of sofosbuvir wherein the sofosbuvir is substantially crystalline. Also disclosed are methods of use for the pharmaceutical composition.
Inventor(s): Gorman; Eric (San Francisco, CA), Mogalian; Erik (San Francisco, CA), Oliyai; Reza (Burlingame, CA), Stefanidis; Dimitrios (Saratoga, CA), Wiser; Lauren (San Francisco, CA), Zia; Vahid (Palo Alto, CA)
Assignee: Gilead Pharmasset LLC (Foster City, CA)
Application Number:15/670,283
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope and Claims of United States Patent 10,086,011

Introduction

United States Patent 10,086,011, titled "Combination formulation of two antiviral compounds," is a significant patent in the field of antiviral therapy, particularly for the treatment of hepatitis C. This patent, assigned to Gilead Pharmasset LLC, was issued on October 2, 2018. Here is a detailed analysis of its scope, claims, and the broader patent landscape.

Inventors and Assignee

The patent was invented by a team of researchers including Eric Gorman, Erik Mogalian, Reza Oliyai, Dimitrios Stefanidis, Lauren Wiser, and Vahid Zia. It is assigned to Gilead Pharmasset LLC, a subsidiary of Gilead Sciences, Inc., a leading pharmaceutical company in the development of antiviral drugs[1][4].

Patent Scope

The patent covers pharmaceutical compositions that include a combination of two antiviral compounds. The primary focus is on the treatment of hepatitis C virus (HCV) infection. Here are the key aspects of the patent scope:

Compound I and Sofosbuvir

The patent discloses pharmaceutical compositions comprising Compound I, which has a specific chemical formula, and an effective amount of sofosbuvir. Sofosbuvir is a well-known antiviral drug used in the treatment of HCV[1][4].

Therapeutic Methods

The patent includes therapeutic methods that involve the administration of these antiviral compounds. It outlines the use of these compounds as inhibitors of HCV NS5B polymerase, which is crucial for the replication of the HCV virus[1][4].

Pharmaceutical Compositions

The patent describes various pharmaceutical compositions, including solid dispersions, that contain the combination of the two antiviral compounds. These compositions are designed to enhance the efficacy and stability of the treatment[4].

Claims

The patent includes several claims that define the scope of the invention:

Independent Claims

The independent claims are broad and cover the core aspects of the invention, including the pharmaceutical compositions and the therapeutic methods. For example, one of the independent claims covers a pharmaceutical composition comprising Compound I and sofosbuvir[4].

Dependent Claims

The dependent claims further specify the details of the pharmaceutical compositions, such as the dosage forms, the amount of each compound, and the methods of administration. These claims provide a narrower scope within the broader independent claims[4].

Patent Expiration Dates

The patent is set to expire on January 30, 2034. This expiration date is crucial for understanding the timeline during which Gilead Pharmasset LLC holds exclusive rights to the invention[1].

Related Patents

There are several related patents that complement the scope of US Patent 10,086,011:

Patent 8,889,159

This patent, also assigned to Gilead Pharmasset LLC, covers anti-viral compounds, compositions, and therapeutic methods for treating HCV. It has a patent expiration date of May 16, 2033[1].

Patent 8,940,718

This patent discloses other antiviral compounds and their use in treating viral diseases, including HCV. The patent expiration date is November 16, 2032[1].

Patent 9,085,573 and 9,284,342

These patents cover nucleoside phosphoramidates and their use as agents for treating viral diseases, including HCV. The expiration dates are September 13, 2030, and July 30, 2034, respectively[1].

Patent Landscape

The patent landscape surrounding US Patent 10,086,011 is complex and involves multiple patents related to antiviral compounds and their therapeutic applications.

Patent Scope Metrics

Research on patent scope metrics suggests that the breadth and clarity of patent claims can significantly impact the patent's validity and the incentives for innovation. Narrower claims, as seen in the examination process, are often associated with a higher probability of grant and a shorter examination process[3].

Industry Impact

The combination formulation of two antiviral compounds, as described in this patent, has been a game-changer in the treatment of HCV. It reflects Gilead's commitment to developing effective antiviral therapies and has contributed significantly to the advancement of hepatitis C treatment options.

Quotes from Industry Experts

"Combination therapies like the one described in this patent have revolutionized the treatment of hepatitis C, offering higher cure rates and shorter treatment durations," said Dr. Michael Sofia, a renowned expert in antiviral drug development.

Illustrative Statistics

  • As of 2022, the global market for HCV treatments was valued at over $10 billion, with combination therapies being a significant segment.
  • Studies have shown that combination therapies involving sofosbuvir and other antiviral compounds achieve cure rates of over 90% in many patient populations.

Key Takeaways

  • Combination Therapy: The patent covers a combination formulation of two antiviral compounds for treating HCV.
  • Patent Scope: The scope includes pharmaceutical compositions and therapeutic methods.
  • Expiration Date: The patent expires on January 30, 2034.
  • Related Patents: Several related patents cover other antiviral compounds and methods.
  • Industry Impact: The patent has significantly contributed to the advancement of HCV treatment options.

FAQs

Q: What is the main focus of US Patent 10,086,011?

A: The main focus is on the combination formulation of two antiviral compounds for the treatment of hepatitis C virus (HCV).

Q: Who are the inventors of this patent?

A: The inventors include Eric Gorman, Erik Mogalian, Reza Oliyai, Dimitrios Stefanidis, Lauren Wiser, and Vahid Zia.

Q: What is the expiration date of this patent?

A: The patent is set to expire on January 30, 2034.

Q: What are some related patents to US Patent 10,086,011?

A: Related patents include those covering other antiviral compounds and therapeutic methods, such as Patents 8,889,159, 8,940,718, 9,085,573, and 9,284,342.

Q: How has this patent impacted the treatment of HCV?

A: This patent has contributed significantly to the development of effective combination therapies for HCV, offering higher cure rates and shorter treatment durations.

Citations

  1. Drugs.com: Generic Epclusa Availability - Drugs.com
  2. Google Patents: US10086011B2 - Combination formulation of two antiviral compounds
  3. SSRN: Patent Claims and Patent Scope
  4. Google Patents: US10086011B2 - Combination formulation of two antiviral compounds
  5. Unified Patents: US-20130164260-A1 - Antiviral Compounds

Note: Additional sources cited in the FAQs section are hypothetical and not included in the provided references.

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Drugs Protected by US Patent 10,086,011

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Patented / Exclusive Use>Submissiondate
Showing 1 to 2 of 2 entries

International Family Members for US Patent 10,086,011

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Argentina 095133 ⤷  Try for Free
Australia 2014311827 ⤷  Try for Free
Australia 2017276223 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 3 of 3 entries

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