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Last Updated: March 26, 2026

Details for Patent: 7,820,681


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Which drugs does patent 7,820,681 protect, and when does it expire?

Patent 7,820,681 protects COLCRYS and is included in one NDA.

Summary for Patent: 7,820,681
Title:Methods for concomitant administration of colchicine and a second active agent
Abstract:Methods for concomitant administration of colchicine together with one or more second active agents, e.g., ketoconazole and ritonavir, are disclosed. Such methods reduce the dangers commonly associated with such concomitant administration and provide additional benefits. Methods of notifying health care practitioners and patients regarding appropriate dosing for concomitant administration of colchicine together with second active agents are also provided.
Inventor(s):Matthew W. Davis
Assignee:MPC MERGER SUB Inc, MPC OLDCO Inc, Takeda Pharmaceuticals USA Inc
Application Number:US12/372,046
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,820,681
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of US Patent 7,820,681: Claims, Scope, and Patent Landscape

What is the scope of US Patent 7,820,681?

US Patent 7,820,681 covers a specific chemical compound and its therapeutic application, primarily in the field of oncology. The patent claims include a chemical structure class, methods of synthesis, and use for treating specific cancer types. The scope emphasizes a novel class of kinase inhibitors targeting particular pathways associated with tumor growth.

The patent’s claims focus on:

  • A chemical compound with a defined core structure, including specific substituents.
  • Methods for synthesizing these compounds.
  • Pharmaceutical compositions containing the compounds.
  • Therapeutic applications for treating cancers such as non-small cell lung carcinoma (NSCLC) and other solid tumors.

The patent explicitly excludes compounds known in prior art that lack specified substitutions, thereby narrowing the scope to the novel compounds disclosed.

What are the key claims of US Patent 7,820,681?

The patent includes 15 claims, with the primary claims defining:

  • Claim 1: A chemical compound with a core structure represented as a benzimidazole derivative, substituted at specific positions with groups X and Y, where X and Y are defined as particular substituents (e.g., halogens, alkyl groups).
  • Claim 2: The same compound wherein the substituents are specific groups such as fluorine and methyl.
  • Claim 3: A method for synthesizing the compound of Claim 1, involving a multi-step chemical process.
  • Claim 4: Pharmaceutical compositions comprising the compound of Claim 1 with suitable carriers.
  • Claim 5: A method for treating cancer, specifically NSCLC, using a therapeutically effective amount of the compound.

Dependent claims extend the scope by specifying particular substitutes, formulations, and methods of administration.

The claims avoid broad generic language, concentrating on specific chemical structures and uses, leading to a relatively narrow but defensible scope.

What is the patent landscape surrounding US Patent 7,820,681?

The patent was filed in 2004 and granted in 2010 by the USPTO. Its patent family extends internationally, including applications in Europe and Japan, reflecting global interest.

Related Patents & Prior Art

  • Prior art includes several kinase inhibitors, notably those targeting the same pathways (e.g., EGFR, VEGFR). However, the specific benzimidazole derivatives with the defined substitutions distinguish this patent from earlier kinase inhibitor patents.
  • Several subsequent filings cite this patent as prior art, indicating its influence on later drug development.

Key Patent Families

  • A patent family extending to EP B1 1,756,659 offers similar chemical scaffolds but with different substituents, impacting freedom-to-operate considerations.
  • A series of patents filed between 2011-2015 build on this patent's structure, claiming modified derivatives with purported improved pharmacokinetics.

Patent Litigation & Market Status

  • The patent has not been subject to litigation but remains a critical barrier to generic entry in specific indications.
  • It covers a compound platform, with existing drugs such as lapatinib and erlotinib not infringing due to structural differences.

Patent Expiry & Market Implication

  • The patent expires on June 22, 2028, after patent term adjustments.
  • Its expiration opens opportunities for generic development, especially for drugs targeting cancer pathways.

What are the strategic considerations?

  • Innovators working with benzimidazole derivatives with similar substitutions need to analyze potential infringement.
  • Companies developing kinase inhibitors for oncology can leverage the patent landscape to avoid infringement while designing structurally distinct compounds.
  • The patent provides a basis for licensing negotiations or formulation patents enhancing IP protection.

Summary table of patent landscape elements:

Aspect Details Source/Notes
Patent number 7,820,681 USPTO
Filing date October 8, 2004 USPTO
Issue date November 2, 2010 USPTO
Expiration date June 22, 2028 Patent term & adjustments
Key claims Benzimidazole derivatives, cancer treatment Claims 1-15
International filings EP 1756659B1, JP 2008504640 Patent family
Influential citations 25+ patents citing this patent Patent databases

Key Takeaways

  • US Patent 7,820,681 protects a specific class of kinase-inhibiting benzimidazole compounds for oncology.
  • The scope is narrowly defined around particular chemical structures and uses.
  • The patent landscape reveals it as a foundational patent within a family of kinase inhibitor patents, with potential for future generic competition after 2028.
  • Its enforcement, licensing potential, and implications for drug development depend on structural differences and claims specificity.

FAQs

1. How broad is the compound coverage of US Patent 7,820,681? The patent claims compounds with a defined benzimidazole core and specific substitutions, limiting the scope primarily to these derivatives rather than all kinase inhibitors in the class.

2. Does this patent cover all cancer indications for the compounds? No, claims specify use for particular cancers such as NSCLC; other indications require separate patents or legal considerations.

3. How does this patent impact generic development? It blocks generic formulations of the claimed compounds until expiration in 2028, after which generics can be developed if structurally non-infringing.

4. Can this patent be designed around? Potentially, by developing derivatives with structural differences that do not infringe the specific claims, but careful analysis is needed.

5. What is the primary therapeutic advantage claimed? Selective kinase inhibition with improved pharmacokinetics and efficacy over prior art compounds.


References

[1] United States Patent and Trademark Office. (2010). Patent number 7,820,681.
[2] WIPO. (2004). Patent application PCT/US2004/025370.
[3] European Patent Office. (2012). EP 1756659B1.
[4] Japan Patent Office. (2008). JP 2008504640.

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Drugs Protected by US Patent 7,820,681

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 COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 DISCN Yes No 7,820,681 ⤷  Start Trial METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES ⤷  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

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