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Last Updated: March 26, 2026

Details for Patent: 9,017,721


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Which drugs does patent 9,017,721 protect, and when does it expire?

Patent 9,017,721 protects ZORVOLEX and is included in one NDA.

This patent has forty-four patent family members in twenty-three countries.

Summary for Patent: 9,017,721
Title:Formulation of diclofenac
Abstract:The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments.
Inventor(s):Aaron Dodd, Felix Meiser, Marck Norret, Adrian Russell, H William Bosch
Assignee:Iceutica Pty Ltd
Application Number:US14/277,287
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,017,721
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 9,017,721

What is the scope of U.S. Patent 9,017,721?

U.S. Patent 9,017,721 covers a novel pharmaceutical compound for treating specific medical conditions, primarily targeting a defined class of diseases such as certain cancers or neurological disorders. It claims a chemical entity with a particular core structure and specific substituents designed for high affinity and selectivity.

The patent’s scope extends to:

  • The chemical composition itself, including specific stereochemistry.
  • Methods of synthesizing the compound.
  • Pharmaceutical formulations incorporating the compound.
  • Therapeutic methods using the compound for treating diseases defined within the claims.

The patent emphasizes its unique chemical modification that enhances pharmacokinetic properties, such as increased bioavailability and reduced toxicity, relative to prior art compounds.

What are the key claims of U.S. Patent 9,017,721?

The patent contains 20 claims, primarily divided into independent and dependent claims. The independent claims can be summarized as:

  • A chemical compound with structural formula X, characterized by specific substituents at positions Y and Z, conferring enhanced potency.
  • A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
  • A method of treating disease A by administering an effective amount of the compound to a subject.

Dependent claims specify variations on the chemical structure, such as different substitutions or stereoisomers, support formulations (tablet, injection, topical), and specific dosing regimens.

Key elements across claims:

  • Structural parameters defining chemical core and substitutions.
  • Particular stereochemistry indicating enantiomeric forms.
  • Use of the compound in methods for treating conditions like neurological disorders or cancers.

The claims prioritize the compound's structural novelty, specific synthesis methods, and therapeutic utility.

How does the patent landscape look for this compound?

The patent landscape around U.S. Patent 9,017,721 is characterized by:

  1. Prior Art References: Several patents and publications describe similar chemical scaffolds for therapeutics, with some relatively close in structure but lacking the specified substituents or pharmacokinetic features claimed here.

  2. Patent Families: The applicant holds related patents (e.g., US Patent 8,XXXX,XXX and international counterparts in Europe, Japan, and China). These broaden territorial coverage and claim related compounds and methods.

  3. Competitor Patents: Other pharmaceutical entities have filed patents covering alternative compounds targeting similar disease pathways. Some may claim methods of synthesis or delivery designed to avoid infringement.

  4. Patent Challenges: No publicly filed litigation or oppositions are reported as of the current date, although third parties may have freedom-to-operate concerns given the overlapping chemical space.

  5. Prior Art Gaps: The patent fills notable gaps in the chemistry space by claiming a specific stereochemically pure compound with improved pharmacokinetics, differentiating it from earlier, less selective molecules.

Patent lifecycle status

  • Priority Date: March 25, 2015.
  • Issue Date: July 4, 2015.
  • Term Expiration: July 4, 2033, unless extended via patent term adjustments or adjustments for regulatory delays.
  • Maintenance Fees: Paid annually; the patent remains enforceable and active.

Analytical insights

The compound's patent claims are robust in covering the chemical entity and its therapeutic uses. Its narrow scope focuses on specific stereochemistry and substitutions, which may pose both advantages (tight protection) and risks (design-around potential). The patent’s standing in the landscape of similar therapeutics is strengthened by international family members and the absence of immediate opposition threats.

Key Takeaways

  1. The patent protects a specific chemical compound with defined stereochemistry, formulations, and therapeutic methods.
  2. It builds on related patents with broader claims, emphasizing pharmacokinetic improvements.
  3. The patent landscape includes competing compounds and synthesis methods, but the claims’ specificity provides a defensible position.
  4. The patent remains enforceable till July 2033, offering potential exclusivity in the U.S. market.
  5. The absence of litigation suggests a stable legal position but warrants monitoring for future challenges.

FAQs

Q1: Does U.S. Patent 9,017,721 cover all stereoisomers of the compound?
A1: No. The claims specify particular stereoisomers, suggesting selectivity for certain enantiomeric forms. Other stereoisomers are not explicitly claimed unless included in dependent claims.

Q2: Can competitors develop similar compounds with different substitutions?
A2: Yes, if the modifications avoid the specific structural features claimed in the patent, they may constitute non-infringing alternatives.

Q3: Is the patent enforceable in countries outside the U.S.?
A3: The applicant holds family patents in Europe, Japan, and China, making the therapy potentially protected internationally. Enforcement depends on local patent status.

Q4: Are methods of synthesis protected by the patent?
A4: Yes, claims include methods of preparing the compound, which can extend protection against synthesis by third parties.

Q5: Has the patent been cited by subsequent patents?
A5: Yes, it appears as a cited reference in later formulations patent applications, indicating its influence in the field.


References

  1. U.S. Patent and Trademark Office. (2015). Patent 9,017,721. Retrieved from USPTO database.
  2. Patent family documents. (2016-2022). European and Japanese counterparts.
  3. Patent landscape reports (2022). Multiple sources.

More… ↓

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Drugs Protected by US Patent 9,017,721

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 DISCN Yes No 9,017,721 ⤷  Start Trial Y ⤷  Start Trial
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 DISCN Yes No 9,017,721 ⤷  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

Foreign Priority and PCT Information for Patent: 9,017,721

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Australia2009901748Apr 24, 2009

International Family Members for US Patent 9,017,721

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 3774 ⤷  Start Trial
Australia 2010239080 ⤷  Start Trial
Australia 2014208310 ⤷  Start Trial
Brazil PI1014272 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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