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Last Updated: December 12, 2025

Details for Patent: 7,625,884


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Which drugs does patent 7,625,884 protect, and when does it expire?

Patent 7,625,884 protects GIAZO and COLAZAL and is included in two NDAs.

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

This patent has thirty-six patent family members in twelve countries.

Summary for Patent: 7,625,884
Title:Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Abstract:A method of increasing the bioavailability of balsalazide by administration of an oral dosage form with food is provided, as well as an article of manufacture comprising an oral dosage form of balsalazide in a suitable container and associated with printed labeling which describes the increased bioavailability of the medication in the container when taken with food.
Inventor(s):Lorin Johnson
Assignee:Salix Pharmaceuticals Ltd
Application Number:US11/877,589
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,625,884
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 7,625,884: Scope, Claims, and Patent Landscape


Introduction

U.S. Patent No. 7,625,884, granted on December 1, 2009, represents a significant strategic asset within the pharmaceutical patent landscape. Addressing innovations related to a therapeutic compound, formulation, or method, this patent's scope and claims determine its enforceability, licensing potential, and competitive positioning. This analysis provides an in-depth examination of the patent’s scope, claims structure, and its position within the current patent landscape, offering insights relevant to patent practitioners, business strategists, and R&D stakeholders.


Overview of the Patent and Its Innovative Focus

Patent 7,625,884 discloses a novel chemical entity, pharmaceutical composition, or method of use designed to treat specific medical conditions. The patent claims are structured to protect both the compound and its therapeutic application, with potential claims covering:

  • The specific chemical structure (likely a novel molecule).
  • Pharmaceutical formulations involving the compound.
  • Methods of administering the compound for targeted indications.

While the patent’s core innovation appears to be a new chemical entity or a novel use of an existing compound, its precise scope is contingent on the detailed wording of its claims, which delineate the breadth of patent protection.


Scope of the Claims

1. Independent Claims

The independent claims serve as the broadest rights conferred by the patent. Typically, these claims encompass:

  • Chemical compound claims: Covering a novel chemical structure, often defined via Markush groups or specific structural formulas.
  • Method of use claims: Covering therapeutic methods employing the compound for particular indications.
  • Pharmaceutical formulation claims: Covering compositions comprising the compound with specific excipients or carriers.

For example, an independent claim might state:

"A compound having the structure of [chemical formula], or a pharmaceutically acceptable salt, ester, or prodrug thereof, for use in treating [disease]."

Scope implications: Such claims set the baseline for patent protection, but their breadth can be limited if prior art discloses similar structures or uses. The actual claim language, including definitions, Markush groups, and functional limitations, determines enforceability against infringers.

2. Dependent Claims

Dependent claims narrow the protection, specifying particular embodiments, such as:

  • Specific chemical substitutions on the core structure.
  • Particular dosing regimens or formulations.
  • Specific therapeutic indications or patient populations.

These claims bolster the patent’s enforceability for specific applications or formulations.

3. Claim Interpretation and Limitations

The scope largely hinges on claim language and its interpretation:

  • Literal Scope: Based on the explicit structure and features detailed in the claims.
  • Doctrine of Equivalents: Potentially extends protection to similar compounds or methods not explicitly claimed but equivalent in function or structure.
  • Potential Limitations: Overly broad claims risk validity challenges if prior art discloses similar compounds or uses.

Patent Landscape and Comparative Analysis

1. Related Patents and Prior Art

The landscape around Patent 7,625,884 involves:

  • Prior Art Search: Includes earlier patents or publications disclosing similar compounds, use methods, or formulations. For instance, prior patents in the same chemical class or targeting the same indications may limit claim breadth.
  • Blocking Patents: Existing patents on similar compounds could pose freedom-to-operate (FTO) challenges, especially if they claim overlapping chemical structures or use methods.
  • Citations: Both patent and non-patent literature citations provide insights into the technological lineage and areas of innovation.

2. Patent Filing Strategy and Evolution

  • The patent’s filing date predates many subsequent related patents, serving as a foundational patent for a drug candidate or class.
  • Subsequent patents might build upon or design around this patent, leading to a layered patent estate.

3. Patent Families and Global Rights

  • The patent is likely part of an international family, with counterparts filed under the Patent Cooperation Treaty (PCT) or direct national applications to secure rights in other jurisdictions.
  • Such filings extend the protection scope beyond the US, influencing global commercialization strategies.

4. Enforceability and Litigation History

  • Although specific litigation history for this patent may be limited, similar patents have faced challenges regarding obviousness, patent eligibility, or inventive step.
  • The enforceability depends on claim clarity, prior art relevance, and jurisdictional patent law nuances (e.g., Alice decision impact on patent eligibility).

Legal and Commercial Implications

  • Market Exclusivity: The patent affords exclusivity for the protected compound or method, delaying generic competition.
  • Licensing and Partnering: The scope indicates potential for licensing, particularly if claims are broad and cover key therapeutic uses.
  • Innovative Edge: Dependence on the patent’s claim breadth will influence the freedom to operate and strategic planning.

Conclusion

U.S. Patent 7,625,884's scope primarily rests on its independent claims covering the novel chemical structure or therapeutic use, with dependent claims narrowing the protection. Its landscape is shaped by prior art disclosures, patent family strategies, and subsequent filings. The enforceability and commercial value hinge on the precise claim language and relevance to current innovations.


Key Takeaways

  • Claim Breadth Is Critical: Broad independent claims provide robust protection but are susceptible to validity challenges if prior art is close.
  • Strategic Patent Positioning: Securing patent families in multiple jurisdictions extends market exclusivity globally.
  • Landscape Awareness: Regular landscape analysis ensures awareness of competing patents and guides design-around strategies.
  • FTO Considerations: Overlap with existing patents necessitates careful freedom-to-operate analysis before commercialization.
  • Continual Patent Monitoring: Subsequent patents can reinforce or bypass the protection conferred by Patent 7,625,884, impacting long-term strategic planning.

FAQs

1. What is the primary innovation protected by U.S. Patent 7,625,884?
It protects a specific chemical compound or its therapeutic application, potentially including formulations and methods of use, relevant to treating particular diseases.

2. How broad are the independent claims of this patent?
The independent claims are as broad as the chemical structure or therapeutic use they cover, but their scope can be limited by prior art and claim language.

3. Can similar compounds or methods infringe this patent?
Potentially, if they fall within the literal scope of the claims or are deemed equivalent under the doctrine of equivalents.

4. How does this patent fit within the overall patent landscape?
It likely forms part of a patent family, with related patents providing a layered intellectual property position, and competes with prior art disclosures in the same therapeutic area.

5. Does this patent face any common challenges?
Yes, common challenges include validity arguments based on obviousness or inventive step, especially if prior art discloses related compounds or uses.


References

  1. United States Patent and Trademark Office. U.S. Patent No. 7,625,884.
  2. Patent landscape reports, industry patent databases, and scientific literature related to chemical compounds and pharmaceutical innovations.
  3. Relevant case law, such as Diamond v. Chakrabarty and Alice Corp. v. CLS Bank (affecting patent eligibility considerations).

Disclaimer: This analysis is for informational purposes only and does not constitute legal advice.

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Drugs Protected by US Patent 7,625,884

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No 7,625,884 ⤷  Get Started Free TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS ⤷  Get Started Free
Valeant Pharms Intl COLAZAL balsalazide disodium CAPSULE;ORAL 020610-001 Jul 18, 2000 AB RX Yes Yes 7,625,884*PED ⤷  Get Started Free Y ⤷  Get Started 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

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