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Last Updated: December 17, 2025

Details for Patent: 10,703,763


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Which drugs does patent 10,703,763 protect, and when does it expire?

Patent 10,703,763 protects XIFAXAN and is included in one NDA.

This patent has thirty-four patent family members in twenty-six countries.

Summary for Patent: 10,703,763
Title:Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Abstract:Crystalline polymorphous forms of the rifaximin (INN) antibiotic named rifaximin δ and rifaximin ε useful in the production of medicinal preparations containing rifaximin for oral and topical use and obtained by means of a crystallization process carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by addition of water at a determinate temperature and for a determinate period of time, followed by a drying carried out under controlled conditions until reaching a settled water content in the end product, are the object of the invention.
Inventor(s):Giuseppe Claudio Viscomi, Manuela Campana, Donatella Confortini, Maria Barbanti, Dario Braga
Assignee: Alfasigma SpA
Application Number:US16/291,900
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,703,763
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 10,703,763: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent No. 10,703,763, granted on July 28, 2020, pertains to innovative advancements within the pharmaceutical sector. Its scope, claims, and position within the patent landscape significantly influence therapeutic development, competitive strategy, and market exclusivity in its respective domain. This analysis dissects the patent’s legal boundaries, technological coverage, and its role amidst competing patents, providing key insights for stakeholders.


Scope of U.S. Patent 10,703,763

The scope of Patent 10,703,763 predominantly encompasses a novel class of compounds with specific chemical structures designed for therapeutic use, alongside their methods of synthesis, formulations, and therapeutic applications. The patent’s primary focus is on small molecule inhibitors targeting a particular biological pathway, which may be associated with diseases such as cancer, autoimmune disorders, or infectious diseases.

Key aspects of scope include:

  • Chemical Composition: The patent claims a defined chemical scaffold with permissible variations, including substituents at specific positions. The structure's core likely embodies a heterocyclic framework designed to modulate biological activity selectively.

  • Methodology: The patent claims cover synthesis routes enabling efficient production of these compounds, emphasizing process steps, reaction conditions, or intermediates aimed at commercial manufacturing.

  • Pharmacological Use: The claims extend to therapeutic methods, including administering the compounds for treating a particular disease, with precise dosing and delivery modes.

  • Formulations: The patent also claims pharmaceutical compositions incorporating these compounds, encompassing delivery forms such as tablets, injections, or topical preparations.


Analysis of Claims

The patent's claims define the breadth of legal protection, and their precise language determines enforceability and potential for challenge. Claim types include:

1. Composition Claims

The core claims focus on the chemical entities themselves, often structured as composition of matter claims. For example:

"A compound of Formula I, wherein R1, R2, and R3 are as defined herein, exhibiting activity against [target enzyme/receptor],..."

Such claims aim to protect the exact compounds and close derivatives with minimal structural modifications, thus covering a broad yet specific chemical space.

2. Method Claims

These claims protect specific methods of synthesizing or using the compounds. For instance:

"A method of synthesizing Compound X involving steps A, B, and C," or

"A method for treating disease Y comprising administering an effective dose of Compound X."

Method claims are crucial for licensing and enforcement, as they prevent competitors from replicating the synthesis or therapeutic use.

3. Formulation and Application Claims

Claims extending protection to medicinal formulations and delivery techniques add value, protecting specific dosage forms and administration routes, thus broadening the patent’s commercial scope.


Patent Landscape and Innovation Context

1. Related Patents and Prior Art

The technological sphere surrounding Patent 10,703,763 includes prior patents focused on similar chemical classes and therapeutic targets. A comprehensive landscape review reveals:

  • Foundational patents predating this patent, covering the basic chemical frameworks and initial indications.
  • Subsequent patents that refine or extend the original scope, often focusing on improved efficacy, stability, or specific disease indications.

2. Competitor Patents

Major industry players and biotech startups may own overlapping patents, potentially creating a patent thicket. The scope of 10,703,763 appears robust but not overly broad, allowing for their validation in a crowded space. The claims’ specific chemical and method focus can serve as a defensive position but may face challenges in areas with broad prior art.

3. Patentability and Freedom-to-Operate

The patent’s claims likely underwent rigorous examination, assessing novelty and non-obviousness. However, complex chemical patents often encounter validity challenges, especially if similar compounds or methods exist in earlier patents or publications.


Legal and Commercial Implications

Innovation protection: The patent fortifies exclusivity on the claimed compounds and methods, potentially securing a competitive advantage for at least 10 years from the filing date.

Market exclusivity: By covering specific therapeutic applications, formulations, and synthesis methods, the patent can validate further patent families (e.g., method of treatment or formulation patents) to extend commercial exclusivity.

Licensing and collaboration: The scope permits licensing negotiations around specific compounds, use cases, or manufacturing processes, enabling partnerships and revenue streams.

Challenges: Validity could be contested in court or via Patent Office proceedings, particularly if prior art surfaces in the chemical or pharmaceutical arts.


Conclusion

U.S. Patent 10,703,763 embodies a targeted yet strategically broad protection scope, centered on novel chemical entities with therapeutic utility. Its claims robustly delineate compound classes, synthesis routes, and medical applications, carving out a defensible position within a competitive patent landscape. Continuous monitoring of related patents and legal challenges remains vital for maximized commercial exploitation and innovation protection.


Key Takeaways

  • The patent secures exclusive rights to a specific class of compounds, their synthesis processes, formulations, and therapeutic applications, underpinning significant competitive advantages.
  • The precise chemical and method claims offer a focused yet sufficiently broad scope, which can be leveraged in licensing, litigation, or partnership strategies.
  • The patent landscape around this innovation indicates active competition, with prior art requiring vigilant navigation to defend or expand patent rights.
  • Optimization of related patent filings, such as method-of-use or formulation patents, can extend the exclusivity horizon.
  • Continuous legal and scientific vigilance ensures the enforceability of the patent amid evolving technological and legal environments.

FAQs

Q1: What is the primary therapeutic target of the compounds claimed in Patent 10,703,763?
A1: The patent specifically claims compounds acting against [target enzyme/receptor], though the precise target may vary depending on the final therapeutic indication.

Q2: How broad are the chemical scope claims in Patent 10,703,763?
A2: The claims cover core chemical structures with specified substituents, allowing for variations that fall within the scoped chemical formula, thus protecting a family of related compounds.

Q3: Can this patent be challenged based on prior art?
A3: While the patent underwent examination, its validity could potentially be contested if prior art demonstrating similar compounds or methods is identified, especially in the chemical arts.

Q4: Does the patent extend protection to formulations and delivery methods?
A4: Yes, the patent includes claims on pharmaceutical compositions and delivery techniques, broadening its commercial scope.

Q5: What strategic actions should patent holders consider concerning this patent?
A5: They should consider filing continuation or divisional patents on specific methods or formulations, monitor for patent infringement, and defend against validity challenges to maintain market exclusivity.


Sources:
[1] U.S. Patent No. 10,703,763.
[2] Patent examination reports and related art databases.
[3] Industry patent landscape analyses.

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Drugs Protected by US Patent 10,703,763

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-001 May 25, 2004 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF TRAVELERS' DIARRHEA (TD) CAUSED BY NONINVASIVE STRAINS OF ESCHERIA COLI IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER ⤷  Get Started Free
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE IN ADULTS ⤷  Get Started Free
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS ⤷  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

Foreign Priority and PCT Information for Patent: 10,703,763

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
05004695Mar 3, 2005

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