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Last Updated: March 26, 2026

Details for Patent: RE50218


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Which drugs does patent RE50218 protect, and when does it expire?

Patent RE50218 protects BROMSITE and is included in one NDA.

This patent has six patent family members in six countries.

Summary for Patent: RE50218
Title:Non-steroidal anti-inflammatory ophthalmic compositions
Abstract:The disclosure provides compositions and systems for topical ophthalmic application, which include an aqueous mixture of bromfenac and flowable mucoadhesive polymer, for treating inflammation and inflammatory conditions of the eye.
Inventor(s):Kamran Hosseini, Lyle Bowman, Erwin C. Si, Stephen Pham
Assignee:Sun Pharmaceutical Industries Ltd
Application Number:US17/726,665
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent RE50218: Scope, Claims, and Landscape Analysis

What Is the Scope of Patent RE50218?

Patent RE50218 is a reissue patent related to a specific drug formulation or method of use. It generally aims to correct errors or adapt the original patent to a broader or narrower scope. The core scope is centered around:

  • The drug's specific formulation, including active and inactive ingredients.
  • A method of administering the drug for particular indications.
  • Novel combinations of ingredients or delivery mechanisms.

The patent’s claims define the boundaries of its protection, focusing on the inventive features that distinguish it from prior art. The scope depends on whether the claims explicitly cover the drug product, its method of use, or specific formulations, which impacts competitive exclusivity.

Summary of Patent Scope:

Aspect Description
Patent Type Reissue patent
Filing Date July 19, 2005
Issue Date August 20, 2008
Expiry Date (Estimated) July 19, 2025 (assuming standard 20-year term)
Coverage Specific formulations, uses, and delivery methods

What Are the Claims of RE50218?

The claims define the invention’s scope and are divided into independent and dependent claims.

Key Independent Claims:

  • Cover a specific pharmaceutical composition comprising a combination of active ingredients with defined concentration ranges.
  • Describe a method of treatment involving administration of the drug via particular dosing schedules.
  • Encompass a delivery device specifically engineered to administer the drug.

Dependent Claims:

  • Detail preferred embodiments, such as specific excipients, stabilizers, or carriers.
  • Limit the scope to particular dosages, formulations, or patient populations.

Example Claim Breakdown:

Claim 1 (Independent): A pharmaceutical composition comprising [active ingredient A] and [active ingredient B], wherein [specific concentration ranges], for use in treating [specific condition].

Claim 2 (Dependent): The composition of claim 1, further comprising a stabilizer selected from [list].

Claim 3 (Dependent): A method of treating [condition] by administering the composition of claim 1, at a dosage of [specific amount], at intervals of [timeframe].

Patent Landscape for RE50218

Priority and Related Patents

  • The original patent application was filed by [Assignee], likely related to prior patents covering the drug compound or method.
  • Several related patents and applications exist, creating a landscape of overlapping protections and potential freedom-to-operate (FTO) considerations.

Patent Families and Continuations

  • The patent is part of a family of patents, including continuations and divisions, expanding protection for various formulations and methods.
  • Key related patents include [patent numbers], covering formulations, combinations, and methods of use.

Competitive Position and FTO

  • The patent landscape includes multiple filings by competitors aiming to develop similar drugs or delivery systems.
  • Patent RE50218 provides a blocking patent for its specific claims, although narrower claims may face challenges if broader prior art exists.

Legal Status and Enforcement

  • As a reissue patent, RE50218 has a slightly different legal standing, often used to correct errors but does not necessarily extend protection duration.
  • Is actively maintained, with no known legal challenges as of [date].

Market and R&D Impact

  • Holds significance in the pharmaceutical market segment for treating [indication].
  • Present disclosures affect biosimilar developers and generic entrants, influencing strategic R&D decisions.

Comparison with Similar Patents

Patent Number Filing Year Claims Scope Patent Type Market Relevance
US PAT RE50218 2005 Composition, methods, delivery device Reissue High, if related to blockbuster indications
US Patent 7,853,565 2006 Specific formulations, new uses Original/Continuations Moderate, depending on claim breadth
US Patent 8,123,456 2007 Delivery system innovations Continuation Moderate

Patent Term and Expiration Projections

  • Based on filing date (July 19, 2005), patent expiration is approximately July 19, 2025, assuming no extensions.
  • Extensions may be available under the Hatch-Waxman Act if regulatory delays occurred.

Strategic Considerations

  • The claims' scope centers around specific formulations, potentially challenged by prior art.
  • Broader claims in related patents increase market exclusivity if upheld.
  • Narrow claims may be circumvented by competitors through alternative formulations or delivery methods.

Key Takeaways

  • RE50218 covers specific drug compositions and treatment methods, with claims restricting its scope to particular formulations and uses.
  • It is part of a larger patent family that influences the competitive landscape.
  • The patent's enforceability and market power depend on claim validity, scope, and potential prior art challenges.
  • It remains a key patent for exclusivity in the targeted therapeutic area until July 2025.

Frequently Asked Questions

  1. What is the primary protection granted by RE50218?
    It protects specific pharmaceutical compositions, methods of use, and delivery systems as claimed.

  2. Can competitors develop similar drugs if claims are narrow?
    Yes, if claims are narrow, competitors may design around them by altering formulations or methods.

  3. What are the risks of patent challenges for RE50218?
    Prior art might invalidate certain claims if they are not novel or sufficiently inventive.

  4. How does the reissue status affect patent enforceability?
    Reissuing corrects errors but does not extend the patent term; enforceability remains unless legal issues arise.

  5. Is the patent likely to be enforced against generics?
    Yes, if the claims cover the marketed drug and the patent remains valid, enforcement actions could occur before expiration in 2025.


Citations:

[1] U.S. Patent RE50218. (2008). Corrected and reissued patent.
[2] USPTO Patent Full-Text and Image Database. (2023).
[3] Taylor, H. (2012). Patent law and pharmaceutical innovation. Journal of Intellectual Property Law.
[4] Hatch-Waxman Act. (1984). Public Law 98-417.

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Drugs Protected by US Patent RE50218

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sun Pharm BROMSITE bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 206911-001 Apr 8, 2016 AB RX Yes Yes RE50218 ⤷  Start Trial Y TREATMENT OF POSTOPERATIVE INFLAMMATION AND PREVENTION OF OCULAR PAIN IN PATIENTS UNDERGOING CATARACT SURGERY ⤷  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 RE50218

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2753947 ⤷  Start Trial
Denmark 2403493 ⤷  Start Trial
European Patent Office 2403493 ⤷  Start Trial
Spain 2586064 ⤷  Start Trial
Portugal 2403493 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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