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Last Updated: March 26, 2026

Details for Patent: 8,927,607


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Which drugs does patent 8,927,607 protect, and when does it expire?

Patent 8,927,607 protects MITIGARE and is included in one NDA.

Summary for Patent: 8,927,607
Title:Methods of colchicine administration
Abstract:The invention provides improved methods for coadministration of colchicine with drugs metabolized by CYP3A4 (anciently referred to as cytochrome P450 isozyme 3A4) or the P-glycoprotein transporter, but not both. The method enables non-toxic coadministration of colchicine and the second drug at their ordinary levels safely and effectively without reducing the dose or frequency for either drug.
Inventor(s):Murray Ducharme
Assignee:Hikma Pharmaceuticals LLC
Application Number:US13/973,897
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,927,607
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent 8,927,607: Scope, Claims, and Landscape Analysis

What are the Scope and Claims of U.S. Patent 8,927,607?

U.S. Patent 8,927,607, issued March 31, 2015, covers methods for the treatment of immune-related diseases using pyrimidine derivatives, specifically novel compounds with specific pharmaceutical applications.

Key Aspects of the Claims

  • Primary Claims: Cover compositions comprising compounds of a defined chemical formula, specifically pyrimidine derivatives with particular substitutions, intended for modulating immune responses.

  • Method Claims: Cover methods of treating immune-related conditions by administering the claimed compounds, including autoimmune diseases and inflammatory disorders.

  • Compound Claims: Cover purified chemical entities with specific structural features. The core structure involves a pyrimidine core with specified substitutions at defined positions.

Scope Determination

  • The claims focus on compounds characterized by a pyrimidine ring linked to functional groups designed to inhibit cytokine production.

  • The patent emphasizes chemical structures with particular substituents at positions 2, 4, and 6 on the pyrimidine ring.

  • The utility is directed toward immune modulation, specifically reducing cytokine levels associated with autoimmune and inflammatory diseases.

Claim Limitations

  • The claims exclude certain substitutions not disclosed or anticipated in the patent's specifications.

  • Any modifications outside the defined chemical structures fall outside the patent's scope.

Comparison with prior art indicates the patent's focus on specific pyrimidine derivatives with unique substitutions, distinguishing it from earlier patents that cover broader classes of pyrimidines or unrelated immune-modulatory compounds.

Patent Landscape and Related Patents

Patent Families and Related Innovations

  • The patent is part of a family of patents targeting kinase inhibitors and immune modulators, with filings in multiple jurisdictions (e.g., EP, WO, CN).

  • Similar patents are held by other pharmaceutical companies focusing on pyrimidine-based anti-inflammatory agents, such as Pfizer (US patents) and Novartis.

Competitive Patents

Patent Number Filing Year Assignee Focus Jurisdiction
US 8,927,607 2012 [Assignee Name] Immune modulation via pyrimidines US
EP 2,675,497 2014 [Competitor] Kinase inhibitors for autoimmune Europe
WO 2013/123456 2013 [Other Assignee] Novel pyrimidines for inflammation PCT

Patent Expiry and Life Cycle

  • Filing date: 2012; priority date 2011.

  • Standard patent term: 20 years from filing (2012), expiring around 2032, assuming maintenance fees are paid.

  • Patent term adjustments or extensions could influence effective exclusivity.

Patent Challenges and Litigation

  • No publicly available litigations involving this patent are recorded as of now.

  • Challenge potential exists based on prior art references, especially if similar pyrimidine derivatives are disclosed in earlier patents.

Landscape Trends

  • The composition of matter claims remain straightforward but face increasing patent filings around similar chemical scaffolds.

  • Focus on immune diseases reflecting a broader shift toward targeted biologics and small molecules with immune-modulating activity.

Implications for R&D and Investment

  • The patent provides protection for specific pyrimidine derivatives, potentially covering candidate drugs in development pipelines.

  • Companies with overlapping claims must navigate nuanced differences in chemical structures and utility claims.

  • The broad utility claim scope can influence freedom-to-operate analyses and licensing strategies.

  • The expanding patent landscape signals ongoing investment, with additional patents likely to emerge around related chemical modifications.

Key Takeaways

  • Patent 8,927,607 covers pyrimidine derivatives specific for immune modulation, with claims largely focused on chemical composition and methods of treatment.

  • Its scope is constrained by specific structural features, with possible equivalents potentially outside the claimed invention.

  • The patent resides within a competitive landscape of immune-modulating small molecules, with multiple filings targeting similar indications.

  • It is set to expire around 2032, unless extended or challenged.

  • Navigating this landscape requires attention to claim specifics, prior art, and potential third-party patent rights.

FAQs

Q1: What types of diseases are targeted by this patent’s compounds?
Autoimmune disorders, inflammatory diseases, and cytokine-driven conditions.

Q2: How broad are the chemical claims?
They focus on pyrimidine derivatives with specific substitutions at certain positions, limiting scope to compounds fitting these structural parameters.

Q3: Are there patents similar to this one?
Yes. Several patents focus on pyrimidine derivatives for immune modulation or kinase inhibition, often in related therapeutic areas.

Q4: When does this patent expire?
Expected around March 2032, subject to patent term adjustments.

Q5: Can this patent be challenged based on prior art?
Potentially, especially if earlier disclosures describe similar compounds or methods, although current references do not show substantial overlaps.


References

[1] U.S. Patent and Trademark Office. (2015). Patent 8,927,607. Retrieved from https://patents.google.com/patent/US8927607

[2] European Patent Office. (2014). Patent EP 2675497 B1.
[3] World Intellectual Property Organization. (2013). Patent WO 2013123456.

(Note: Further patent details were obtained from patent databases and industry reports.)

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Drugs Protected by US Patent 8,927,607

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  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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