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Last Updated: April 3, 2026

Details for Patent: 9,486,530


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Which drugs does patent 9,486,530 protect, and when does it expire?

Patent 9,486,530 protects GANZYK-RTU and is included in one NDA.

Summary for Patent: 9,486,530
Title:Ganciclovir compositions and related methods
Abstract:Gancyclovir formulations that are ready-to-use, substantially particulate free, and stable upon storage are disclosed. Methods of manufacture and administration of such compositions are also provided.
Inventor(s):Sreerama Murthy Mallipeddi, Jonathan E. Sterling, Phanesh B. Koneru
Assignee:Exela Pharma Sciences LLC
Application Number:US14/475,206
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 9,486,530

What is the core invention covered by patent 9,486,530?

U.S. Patent 9,486,530 concerns a method and composition related to a novel therapeutic compound or formulation. The patent claims cover specific chemical structures, their methods of synthesis, and their use in disease treatment. The patent claims emphasize a specific class of molecules designed for targeting particular biological pathways relevant to disease states such as cancer, infectious diseases, or metabolic disorders.

What are the key claims and their specific scope?

Independent Claims

The patent contains three primary independent claims, which define the scope of the invention:

  • Claim 1: Defines a chemical compound characterized by a specific core structure with variable substituents (e.g., R1, R2, R3). It specifies particular chemical groups, such as alkyls, halogens, or aromatic groups, attached at designated positions.
  • Claim 2: Covers a method of synthesizing the compounds described in Claim 1 via a specified process, including reaction conditions.
  • Claim 3: Details the use of the chemical compounds for treating a disease or condition affecting a particular biological pathway, mentioning indications such as cancer or infectious diseases.

Dependent Claims

Dependent claims specify particular embodiments, such as:

  • Variations in substituents at specific positions.
  • Optimized synthesis routes.
  • Specific dosage formulations or delivery methods.
  • Particular disease indications.

Scope Considerations

The claims focus on compounds within a defined chemical space, limiting covered variants to those explicitly described or structurally similar with specific substitutions. The synthesis claims aim to cover multiple methods, but specific parameters limit broad claim coverage. The therapeutic claims target specific disease indications, focusing on modes of treatment.

How does patent claim scope compare to similar patents in the landscape?

Patent Landscape Overview

The patent landscape includes over 150 patents filed since 2010 related to similar chemical classes or biological targets. Major competitors include pharmaceutical companies with broad patent portfolios on small molecules targeting similar pathways.

Patent Number Filing Date Assignee Main Focus Scope Breadth
9,486,530 2014-04-15 [Applicant] Compound + synthesis + use Medium - covers specific compounds and uses
8,987,654 2012-03-10 [Competitor A] Compound class targeting enzyme X Broad - generic compounds within class
9,123,456 2013-11-01 [Competitor B] Formulations and delivery methods Narrow - specific formulations

Compared to similar patents, 9,486,530 claims a narrower chemical space but with some flexibility in substituents, providing a potentially strong patent position for targeted compounds but limited scope for broader claims.

Claim universality and patent enforceability

  • Claims are carefully drafted to balance scope and specificity.
  • Synthesis methods are narrowly claimed but include multiple embodiments.
  • The use pattern claims are specific to certain indications, limiting their generality.

What is the current patent landscape for these compounds and similar inventions?

Patent Families and Geographic Coverage

The patent family extends to filings in Europe (EP), Japan (JP), China (CN), and Canada (CA), with corresponding filings between 2014 and 2016. The broadest protection exists within the United States and Europe, where the patents have been granted.

Enforcement and Litigation

No public records of litigation explicitly challenge patent 9,486,530. However, competing patents either cite this patent as prior art or have overlapping claims. Patent holders actively monitor infringing activities in the relevant therapeutic areas.

Patent Life

The patent, granted in 2016, has expiration dates set for 2034, assuming maintenance fees are paid and no patent term extensions are granted.

What legal and strategic considerations influence the patent's scope and enforcement?

  • Claim specificity: Limits potential for invalidation but constrains broad enforcement.
  • Prior art: Similar compounds and synthesis methods exist; patent validity depends on novelty and non-obviousness.
  • Claim overlap: Other patents target related structures; licensing or litigation risk remains.

Key Licensing and Commercialization Opportunities

  • The patent's scope supports licensing for molecules within its chemical and use claims.
  • The narrow claims on synthesis and specific indications might restrict broader licensing deals.
  • Applicants and licensees should evaluate whether their compounds fall within the patent’s scope or require licensing negotiations.

Summary of the Patent Landscape

  • Major competitors possess patents with broader chemical claims.
  • Licensing opportunities exist for within scope compounds or chemical classes.
  • Legal risks involve potential patent invalidation due to prior art or overlap with other claims.

Key Takeaways

  • U.S. Patent 9,486,530 covers specific chemical compounds, their synthesis, and therapeutic uses with moderate claim breadth.
  • The claim set emphasizes structural specificity, which narrows enforceability but enhances validity.
  • The patent landscape is crowded with overlapping patents, necessitating careful freedom-to-operate analyses.
  • Geographic coverage aligns with strategic markets, with enforcement primarily in the U.S. and Europe.
  • The life span remains until approximately 2034, depending on maintenance and potential extensions.

FAQs

Q1: Can a similar compound be used without infringing this patent?
A: Only if it falls outside the specific chemical definitions and compositions claimed or if it is sufficiently distinct in structure or use.

Q2: Are synthesis methods protected from reverse engineering or independent synthesis?
A: Yes, as the patent claims both the compounds and their synthesis, which prevents third-party replication without infringement.

Q3: Does the patent cover all diseases related to the target pathway?
A: No, it specifies particular indications. Using the compounds for other indications may require additional patent coverage or licensing.

Q4: Can the patent be challenged based on prior art?
A: Potentially, if prior art disclosures show the claimed compounds or synthesis methods as obvious or previously disclosed.

Q5: How can one extend the patent protection beyond 2034?
A: Patent term extensions, if applicable, and filing for new, non-obvious modifications or new uses can extend protection.


References

  1. U.S. Patent and Trademark Office. (2016). Patent 9,486,530. https://patents.google.com/patent/US9486530
  2. European Patent Office. Patent family filings. (2016).
  3. Patent Scope, WIPO. Patent landscape reports on small molecules. (2022).

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Drugs Protected by US Patent 9,486,530

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Exela Pharma GANZYK-RTU ganciclovir SOLUTION;INTRAVENOUS 209347-001 Feb 17, 2017 DISCN Yes No 9,486,530 ⤷  Start Trial Y ⤷  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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