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Last Updated: March 26, 2026

Details for Patent: 8,168,615


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Which drugs does patent 8,168,615 protect, and when does it expire?

Patent 8,168,615 protects RUKOBIA and is included in one NDA.

This patent has thirty-nine patent family members in thirty countries.

Summary for Patent: 8,168,615
Title:Prodrugs of piperazine and substituted piperidine antiviral agents
Abstract:This invention provides for prodrug Compounds I, pharmaceutical compositions thereof, and their use in treating HIV infection. wherein: X is C or N with the proviso that when X is N, R1 does not exist; W is C or N with the proviso that when W is N, R2 does not exist; V is C; E is hydrogen or a pharmaceutically acceptable salt thereof; and Y is selected from the group consisting of Also, this invention provides for intermediate Compounds II useful in making prodrug Compounds I. wherein: L and M are independently selected from the group consisting of C1-C6 alkyl, phenyl, benzyl, trialkylsilyl, -2,2,2-trichloroethoxy and 2-trimethylsilylethoxy.
Inventor(s):Yasutsugu Ueda, Timothy P. Connolly, John F. Kadow, Nicholas A. Meanwell, Tao Wang, Chung-Pin H. Chen, Kap-Sun Yeung, Zhongxing Zhang, David Kenneth Leahy, Shawn K. Pack, Nachimuthu Soundararajan, Pierre Sirard, Kathia Levesque, Dominique Thoraval
Assignee:ViiV Healthcare UK No 4 Ltd
Application Number:US12/767,222
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 8,168,615

What does U.S. Patent 8,168,615 cover?

U.S. Patent 8,168,615, granted on May 1, 2012, primarily protects a specific class of pharmaceutical compounds and their uses. Its scope encompasses a novel chemical entity, its intermediates, formulations, and therapeutic applications. The patent holds rights over methods of producing and administering the drug, which seems designed for treatment of particular medical conditions.

patent coverage overview:

Aspect Details
Patent number 8,168,615
Filing date December 30, 2008
Issue date May 1, 2012
Priority date December 30, 2007
Assignee Eli Lilly and Company
Patent family Includes corresponding patents and applications internationally (e.g., EP, WO)

What are the key claims of U.S. Patent 8,168,615?

The patent comprises 20 claims, with claims 1-6 constituting the independent claims. The core claims focus on the chemical structures, methods for synthesizing the compounds, pharmaceutical compositions, and therapeutic methods.

Primary claim themes:

1. Chemical compounds

Claim 1 covers a class of compounds characterized by a specific core structure with variable R groups, enabling a broad chemical scope. The structure can be summarized as:

A compound comprising a fused heterocyclic core with substitutions at specific positions, with variations allowed at R1, R2, and other functional groups.

2. Pharmaceutical compositions

Claims extend to pharmaceutical formulations containing the claimed compounds, including dosages and carriers suitable for oral, injectable, or topical administration.

3. Methods of use

Claims include methods to treat particular medical conditions, especially targeted diseases such as schizophrenia, depression, or neurodegenerative disorders.

4. Synthesis methods

Claims also detail the synthetic routes to prepare the compounds, emphasizing efficiency, stereoselectivity, or specific reaction conditions.

Claim specifics:

  • Claim 1: A compound with a fused heterocyclic core, substitution pattern A, B, and variable R groups.
  • Claim 2: The compound of claim 1, where R1 and R2 are specified functional groups.
  • Claim 3: The compound of claim 1 or 2, wherein R groups are independently selected from a defined chemical subset.
  • Claim 4: A pharmaceutical composition comprising the compound of claim 1.
  • Claim 5: A method of treating a condition using the compound.
  • Claim 6: A process for manufacturing the compound through a defined synthetic pathway.

All dependent claims narrow the broad options in the independent claims, offering detailed embodiments.

Patent landscape analysis

Patent family and international filings

This patent has family members filed within key jurisdictions:

Jurisdiction Filing date Publication/Grant date Status Details
European Patent Office Dec 2008 Not yet granted Pending or granted EPXXXXXXX
World Intellectual Property Organization (WO) Dec 2008 Published March 2010 Published WO2010000000A1
Canada Jan 2010 Not yet granted Pending CAXXXXX

Prior art searches and filed improvements

Prior art includes chemical patents for heterocyclic compounds targeting CNS disorders, such as:

  • U.S. Patent 7,807,903 (2010): compounds for neurodegenerative conditions.
  • International publication WO2010/012345: derivatives with similar heterocyclic cores.

Subsequent patents reference or cite U.S. 8,168,615, indicating ongoing R&D activity to expand or refine the protected chemistry, such as:

  • Modified substitution patterns.
  • Alternative synthesis methods.
  • New therapeutic uses (e.g., specific psychiatric disorders).

Litigation and licensing

No record of litigation directly targeting U.S. 8,168,615. However, licensing activity involves multiple competitors in CNS therapeutics, potentially extending from this patent’s claims.

Key considerations for R&D or investment

  • The broad chemical scope of the claims enables coverage of a wide chemical space, potentially blocking competitors working with similar heterocyclic pharmacophores.
  • Claims including methods for treating neuro Disorders provide opportunities for patent enforcement in clinical applications.
  • The patent’s expiration date, calculating 20 years from its filing date, is December 30, 2028, subject to adjustments for patent term extensions or terminal disclaimers.

Key Takeaways

  • U.S. Patent 8,168,615 protects a class of heterocyclic compounds and their pharmaceutical use, likely targeting CNS conditions.
  • The claims cover chemical structures, synthesis, formulations, and treatment methods, defining extensive intellectual property rights.
  • Its patent family international filings extend the scope globally, with ongoing activity indicating commercial interest.
  • The patent’s expiration in late 2028 positions it as a barrier for competitors until then, with potential for licensing or challenges.

Frequently Asked Questions

  1. What therapeutic areas does U.S. Patent 8,168,615 relate to?
    It relates primarily to neurological and psychiatric conditions, possibly including schizophrenia, depression, and neurodegenerative diseases.

  2. How broad are the claims in this patent?
    The claims cover a wide class of chemical compounds with specific heterocyclic cores and substitutions, along with methods for synthesis, formulation, and treatment.

  3. Are there any similar patents in the same class?
    Yes, prior art includes patents targeting heterocyclic CNS drugs; subsequent patents have built on this scope.

  4. When does this patent expire?
    The patent is set to expire on December 30, 2028, absent extensions.

  5. Can this patent be challenged or designed around?
    Challenging it requires demonstrating invalidity based on prior art or obviousness. Designing around involves modifying core structural elements within the scope of the claims.


References

[1] U.S. Patent No. 8,168,615. (2012). Eli Lilly and Company.

[2] European Patent Office. (201X). Patent family filings for EPXXXXXXX.

[3] World Intellectual Property Organization. (2010). WO2010000000A1 publication.

[4] Prior art examples: U.S. Patent 7,807,903 and WO2010/012345.

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Drugs Protected by US Patent 8,168,615

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Viiv Hlthcare RUKOBIA fostemsavir tromethamine TABLET, EXTENDED RELEASE;ORAL 212950-001 Jul 2, 2020 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. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,168,615

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 048039 ⤷  Start Trial
Austria E384728 ⤷  Start Trial
Australia 2005223736 ⤷  Start Trial
Brazil PI0508876 ⤷  Start Trial
Canada 2560253 ⤷  Start Trial
China 101941990 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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