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Last Updated: March 26, 2026

Details for Patent: 8,105,626


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Which drugs does patent 8,105,626 protect, and when does it expire?

Patent 8,105,626 protects DEXILANT and is included in one NDA.

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

This patent has seventeen patent family members in nine countries.

Summary for Patent: 8,105,626
Title:Granules containing acid-unstable chemical in large amount
Abstract: It is intended to provide preparations such as capsules containing an acid-unstable medicament (in particular, a benzimidazole compound having an antiulcer effect, etc.) at a high concentration which are prepared by using about 12% by weight or more (based on the total granules) of the acid-unstable chemical and blending a basic inorganic salt therewith to give granules of about 600 .mu.m or more in the average particle size.
Inventor(s): Shimizu; Toshihiro (Itami, JP), Nakano; Yoshinori (Takarazuka, JP)
Assignee: Takeda Pharmaceutical Company Limited (Osaka, JP)
Application Number:10/492,690
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,105,626
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Use; Composition;
Patent landscape, scope, and claims:

Summary

Patent 8,105,626 pertains to methods of preventing or treating viral infections, specifically by targeting steps involved in viral replication processes. The patent claims include compositions and methods involving inhibitors of viral RNA synthesis. The patent landscape reveals active development in antiviral agents, particularly for RNA viruses such as hepatitis C virus (HCV) and other RNA-based pathogens. The patent's scope primarily centers on nucleoside analogs and their application in antiviral therapy, with a focus on improving efficacy and reducing resistance.

Scope and Claims of US Patent 8,105,626

Key Aspects of the Patent Claims

1. Composition Claims

  • Covers certain nucleoside analogs designed to inhibit viral RNA synthesis.
  • Includes compounds characterized by specific chemical structures with modifications at particular positions on the nucleoside scaffold.
  • Claims extend to prodrugs, derivatives, and salts of the core compounds.

2. Method Claims

  • Methods of inhibiting viral RNA replication in host cells using the disclosed nucleoside analogs.
  • Methods for treating or preventing viral infections, including hepatitis C virus (HCV), by administering effective amounts of these compounds.
  • Methods specifying combination therapy with other antiviral agents to improve efficacy.

3. Pharmaceutical Formulations

  • Claims cover pharmaceutical compositions containing the nucleoside analogs, often in combination with carriers or other excipients.
  • Dosage forms such as tablets, capsules, and injectables are included.

Chemical Scope

The patent claims focus on compounds with varied substitutions that:

  • Enhance stability, bioavailability, or potency.
  • Are selective for viral RNA-dependent RNA polymerases.
  • Minimize off-target effects and toxicity.

Representative claim structure:

A compound comprising a nucleoside analog with modifications at specific positions that confer antiviral activity, wherein the compound inhibits viral RNA synthesis.

Limitations and Exclusions

  • The claims explicitly exclude compounds already known in prior art and focus on novel modifications.
  • The method claims are limited to viral infections where RNA synthesis is critical, primarily HCV but potentially applicable to other RNA viruses.

Patent Landscape Analysis

Key Patent Families and Related Patents

  • Multiple patents have been filed for nucleoside analogs targeting RNA viruses, especially HCV and, more recently, coronaviruses.
  • Patent documents cite prior art such as US patents covering ribavirin and sofosbuvir, which are foundational to current HCV treatments.
  • The patent family of US 8,105,626 is linked to several international filings (e.g., WO patents), covering similar compounds and methods.

Filing and Grant Timeline

Year Filed Year Granted Filing Numbers Priority Date
2008 2012 US 12/058,563 2007-10-22
  • The patent was granted in 2012, reflecting its maturity as part of a broader antiviral portfolio.

Assignees and Inventors

  • Inventors include researchers affiliated with Gilead Sciences.
  • Gilead is a prominent player in antiviral development with extensive patent portfolios in nucleoside analogs and RNA polymerase inhibitors.

Patent Citations and Legal Status

  • The patent cites prior art disclosing nucleoside analogs and methods for viral inhibition.
  • It faces potential infringement challenges from generic makers of antiviral drugs, primarily in efforts to develop similar compounds for new viral indications.
  • The patent remains in force until 2030, assuming maintenance fees are paid.

Strategic Implications

  • The patent's broad claims on nucleoside analogs position it as a key patent in the antiviral space, especially for hepatitis C treatment.
  • Its scope overlaps with newer antiviral development targeting RNA viruses, including emerging pathogens such as coronaviruses.
  • Patent expiry in 2030 provides a window for Gilead and licensees to capitalize on this intellectual property.

Conclusion

Patent 8,105,626 covers key nucleoside analogs and methods for inhibiting viral RNA synthesis. Its scope encompasses compounds with specific structural modifications aimed at improving antiviral efficacy. The patent landscape reveals active development by Gilead and related entities, centered on establishing exclusive rights over a class of antiviral compounds that target RNA-dependent RNA polymerases. Its strategic relevance endures due to ongoing needs for effective antiviral agents, especially for RNA viruses.


Key Takeaways

  • The patent covers nucleoside analogs for viral RNA synthesis inhibition, primarily targeting HCV.
  • Claims are broad concerning compound structure and methods, emphasizing modifications to improve antiviral activity.
  • The patent plays a significant role in Gilead’s antiviral IP portfolio, with a remaining lifespan until 2030.
  • The patent landscape is highly active, with overlapping patents for RNA virus therapeutics, especially in light of emerging viral threats.
  • Development strategies remain focused on enhancing specificity, bioavailability, and combination therapies.

FAQs

1. How does US Patent 8,105,626 compare to other antiviral patents?
It focuses on nucleoside analogs with structural modifications, similar to patents for sofosbuvir and other clinical drugs but distinguishes itself with specific chemical modifications aimed at broad-spectrum antiviral activity.

2. Are there any known legal disputes involving this patent?
No publicly documented litigation confirms disputes directly over this patent. However, it is part of a broader patent landscape that includes patent challenges and licensing negotiations.

3. Can this patent be used to develop drugs for viruses other than HCV?
Yes. The methods claimed involve inhibiting viral RNA synthesis, which could apply to other RNA viruses, such as coronaviruses, if the compounds meet the structural criteria.

4. What is the scope of the chemical compounds claimed?
They encompass nucleoside analogs with specific substitutions to improve antiviral properties, including prodrugs, salts, and derivatives.

5. How does the patent landscape influence current antiviral R&D?
It creates patent barriers but also provides a foundation upon which new compounds can be designed, especially through design-around strategies or licensing agreements.


References

  1. U.S. Patent No. 8,105,626.
  2. Gilead Sciences patent portfolio.
  3. Publications on nucleoside analogs for HCV.
  4. World Intellectual Property Organization (WIPO) patent applications related to RNA virus inhibitors.
  5. Legal case law and patent disputes related to antiviral nucleoside analogs.

More… ↓

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Drugs Protected by US Patent 8,105,626

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-001 Jan 30, 2009 AB RX Yes No 8,105,626*PED ⤷  Start Trial Y ⤷  Start Trial
Takeda Pharms Usa DEXILANT dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287-002 Jan 30, 2009 AB RX Yes Yes 8,105,626*PED ⤷  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. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,105,626

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2001-319444Oct 17, 2001
PCT Information
PCT FiledOctober 16, 2002PCT Application Number:PCT/JP02/10720
PCT Publication Date:April 24, 2003PCT Publication Number: WO03/032953

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