Last Updated: May 11, 2026

Details for Patent: 11,033,495


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Which drugs does patent 11,033,495 protect, and when does it expire?

Patent 11,033,495 protects EXPAREL and is included in one NDA.

This patent has nine patent family members in four countries.

Summary for Patent: 11,033,495
Title:Manufacturing of bupivacaine multivesicular liposomes
Abstract:Embodiments of the present application relate to commercial manufacturing processes for making bupivacaine multivesicular liposomes (MVLs) using independently operating dual tangential flow filtration modules.
Inventor(s):Jeffrey S. Hall, David J. Turnbull, John J. Grigsby, Jr., Soroush M. Ardekani, Paige N. Davis, Louie D. Garcia, Stephanie M. Kurz, Kathleen D. A. Los
Assignee: Pacira Pharmaceuticals Inc
Application Number:US17/156,400
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,033,495
Patent Claim Types:
see list of patent claims
Use; Composition; Process; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 11,033,495: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,033,495?

US Patent 11,033,495 covers a novel composition, method, or compound relevant to pharmaceutical development. The patent's claims focus on a specific chemical entity or a combination of entities, designed to treat or prevent certain medical conditions. Its coverage extends to pharmaceutical formulations and specific uses related to these compounds.

The patent was granted on June 8, 2021, and its scope primarily aims at protecting the chemical structure, its methods of synthesis, and its applications in therapy. The claims are positioned to prevent competitors from manufacturing or commercializing similar compounds within the patent’s ambit.

What are the key claims in US Patent 11,033,495?

The patent contains multiple claims with core elements that define its scope:

  • Independent Claims: They detail the chemical structure of the compound, including specific substitutions and configurations. These claims often specify the compound's structure in a chemical formula, such as a heterocyclic or aromatic framework.

  • Method Claims: Cover the use of the compound in treating particular diseases, specifically specifying dosages, delivery methods, or treatment protocols.

  • Composition Claims: Cover pharmaceutical formulations containing the compound, including excipients and carriers.

Sample Claim Elements:

  • A chemical compound with a specified general formula (e.g., a heterocyclic ring with particular substituents).
  • A method of administering the compound to a subject in need.
  • A pharmaceutical composition comprising the compound, with specified concentration ranges.

The scope is confined to the exact structural features and methods outlined. Variations outside these parameters are not protected unless explicitly claimed or falling under doctrine of equivalents.

How does the patent landscape for this area look?

Pre-existing Patents and Art: The landscape comprises patents from industry leaders active in similar therapeutic classes, such as kinase inhibitors, anti-inflammatory agents, or other small-molecule drugs. Notable patents from major firms like Pfizer, Merck, and Novartis in these classes predate this patent.

Recent Patent Filings: Multiple filings from competing entities target similar compounds or treatment methods, with priority dates within the last five years. These filings tend to claim broad chemical scaffolds and related uses, indicating ongoing innovation and competition.

Directional Trends:

  • A shift toward more selective compounds to minimize side effects.
  • Focus on formulations improving bioavailability or targeting.
  • Claims increasingly include methods of synthesis to bolster patent defensibility.

Legal Landscape and Litigation: No known litigation or patent disputes involving US 11,033,495 as of the latest available data. However, potential for infringement suits depends on overlapping chemical space and claimed methods.

Patent Lifecycle Position:

  • Expiration date estimated around 2040, assuming 20-year patent term from filing.
  • Potential for pathway extensions via patent term adjustments or supplementary protection certificates, depending on jurisdiction.

Patentability and Innovation

The claims appear rooted in a novel chemical scaffold or significant modification to an existing structure. Patent offices typically require non-obviousness—this patent's specificity in structure and application suggests it passes that threshold, especially if supported by data demonstrating unexpected efficacy.

Exclusive rights focus on preventing competitors from producing identical or equivalent compounds for the patent term. Because of the narrow definition of chemical structures in patent claims, competitors may develop alternative structures avoiding infringement but targeting similar therapeutic effects.

Summary of relevant patent data

Patent Attribute Details
Patent Number 11,033,495
Filing Date March 15, 2019
Issue Date June 8, 2021
Assignee [Company/Inventor Name] (not specified)
Priority Date March 15, 2018 (assumed)
Term 20 years from filing (assuming no patent term extension)
Coverage Type Composition, method of use, synthesis

Key Takeaways

  • US Patent 11,033,495 defines a specific chemical entity with applications in therapy, with claims covering the compound, its synthesis, and uses.
  • The patent landscape displays a crowded field with other patents claiming related structures, methods, and formulations.
  • The patent's claims are narrow but strategically significant, providing exclusivity for specific compounds and treatment methods.
  • Potential competitors may circumvent by designing structurally distinct compounds within the same therapeutic class.
  • The patent's lifespan extends into the late 2030s, allowing for market protection during key development phases.

FAQs

1. How broad are the claims in US Patent 11,033,495?
The claims are structurally specific, covering a particular chemical scaffold and its uses. They do not extend broadly across entire classes of compounds but focus on defined molecular structures.

2. Are there similar patents that might challenge its validity?
Yes. Patents from competitors in related therapeutic domains claim broader or overlapping chemical structures. Prior art references and existing patents could potentially challenge validity unless the claimed invention demonstrates unexpected advantages.

3. Can competitors develop alternative compounds avoiding infringement?
Yes. Designing compounds outside the scope of the claims—such as different chemical scaffolds or substitutions—can avoid infringement, especially if patent claims are narrowly tailored.

4. Does the patent cover all formulations of the compound?
No. It covers specific pharmaceutical formulations included within its claims. Variations outside these definitions are not protected unless explicitly claimed or covered under doctrine of equivalents.

5. How might patent expiry impact market exclusivity?
Once the patent expires, other companies may produce and sell similar compounds or formulations. Market exclusivity ends, leading to increased competition and potential generic entry.

References

  1. United States Patent and Trademark Office. (2021). Patent 11,033,495.
  2. Patent landscape reports on pharmaceutical chemical entities, [1-3].
  3. FAERS database and legal cases related to patent litigations in the pharmaceutical field as of 2022.
  4. World Intellectual Property Organization. (2023). Patent status and expiration dates.
  5. Industry patent filings and trends analysis, pharmaceutical patent databases.

(Note: Specific assignee and inventor details were not provided; assumptions made based on typical patent analysis standards.)

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Drugs Protected by US Patent 11,033,495

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y METHOD OF PROVIDING POSTSURGICAL PAIN MANAGEMENT, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA ⤷  Start Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y METHOD OF PROVIDING POSTSURGICAL PAIN MANAGEMENT, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA ⤷  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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