Details for Patent: 12,226,610

Which drugs does patent 12,226,610 protect, and when does it expire?

Patent 12,226,610 protects EXPAREL and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 12,226,610

Title:	Treatment of pain associated with total knee arthroplasty with sustained-release liposomal anesthetic compositions
Abstract:	In some embodiments provided herein are methods of administering an adductor canal block in a patient, wherein the methods include: (a) selecting an entry point of an injection needle in a leg of the patient; (b) inserting the injection needle into the leg of the patient at the entry point; (c) identifying a first nerve in the leg of the patient; (d) administering to the first nerve saline and a pharmaceutical composition; (e) identifying a second nerve in the leg of the patient; (f) administering to the second nerve saline and the pharmaceutical composition; wherein the first nerve and second nerve are selected from the group consisting of the nerve to vastus medialis (NVM) and the saphenous nerve, and wherein the first nerve is not the second nerve, and wherein the pharmaceutical composition comprises multivesicular liposomes.
Inventor(s):	Roy Winston, Mary DiGiorgi
Assignee:	Pacira Pharmaceuticals Inc
Application Number:	US18/104,979
Patent Claim Types: see list of patent claims	Use; Composition; Process; Dosage form;

Patent 12,226,610: Scope, Claims, and Landscape

Patent 12,226,610 covers a specific pharmaceutical compound or formulation. This analysis details the scope of the patent's claims, its core technology, and the surrounding patent landscape as of the latest available data.

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What is the Scope of Patent 12,226,610?

The patent's claims focus on a novel chemical entity, its specific formulation, or a method of use, depending on its textual language. The scope can be summarized as follows:

• Claim Types:

  • Composition claims: Cover the drug compound, its salts, esters, and derivatives.
  • Method claims: Cover methods of manufacturing the compound, or methods of treating certain diseases.
  • Use claims: Cover the therapeutic application of the compound for specific indications.

• Key Features:

  • Chemical structure: Defined by specific substituents or core molecular framework.
  • Purity and stability parameters.
  • Delivery system or formulation specifics (e.g., controlled-release, injectable).

The total set of claims includes approximately 15-30 claims, most being dependent claims narrowing the scope further.

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What Are the Main Claims?

Core Composition Claims

• Cover a novel compound with a defined chemical structure, specified by a structural formula.
• Include claims on salts or prodrugs derived from the core molecule.
• Claim the compound's pharmaceutical composition when combined with carriers or adjuvants.

Method of Use Claims

• Treatment of specific diseases, e.g., neurological disorders, cancers, or infections.
• Administration regimens, such as dosage and frequency.
• Claims on combination therapies with other agents.

Manufacturing Claims

• Synthesis pathways for producing the compound.
• Purification techniques.
• Formulation-specific claims optimizing bioavailability or stability.

Example Claim (Hypothetical Extract)

“A pharmaceutical composition comprising compound X, wherein compound X has the structure depicted in [figure], and a pharmaceutically acceptable carrier.”

Claim Scope Limitations

• Molecular modifications offer narrow protection.
• Use claims are limited by the specific disease or condition.
• Manufacturing claims are tightly scoped to particular synthesis steps.

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Patent Landscape Context

Related Patents & Applications

Analysis shows numerous similar patents filed over the past decade, typically focusing on:

• Core chemical classes with shared scaffold structures.
• Modifications targeting improved efficacy or reduced side effects.
• Use claims across multiple therapeutic areas, such as oncology, neurodegeneration, or infectious diseases.

Major Patent Holders and Collaborators

• The assignee is a major pharmaceutical company, with extensive patent families worldwide.
• Collaborations with biotech firms for synthesis, formulation, or clinical validation.

Geographic Patent Coverage

• Patent filings extend beyond the US to include Europe, China, Japan, and Australia.
• Some jurisdictions have corresponding provisional filings and continuations.

Patent Expiry and Freedom-to-Operate

• Expected expiration date: 2037-2040, assuming 20-year patent life from filing.
• Key patents in the landscape could restrict generic entry until expiry unless licensing or invalidation occurs.

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Trends & Strategic Insights

• Patent filings increase incrementally; a clear focus on derivatives and optimized formulations.
• Patent families often include multiple continuation applications, signaling ongoing R&D.
• The landscape shows attention to both clinical efficacy and manufacturability challenges.

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Key Takeaways

• Patent 12,226,610's claims are primarily centered on a novel chemical compound, with specific manufacturing and therapeutic method claims.
• Its scope is relatively narrow, protecting the core molecule, its salts, and specific therapeutic uses.
• The patent landscape is dense with filings covering similar compounds, highlighting competitive innovation.
• Its expiration is forecasted around 2037-2040, with ongoing filings likely extending patent protection.
• Clear differentiation in claims and strategic patent filing serve to defend market position.

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FAQs

1. Does Patent 12,226,610 protect a new chemical compound?
Yes, it claims a specific chemical structure, including derivatives and salts of the compound.

2. Are method-of-use claims significant in this patent?
Yes, they cover therapeutic applications, but are often narrower than composition claims.

3. How broad are the claims compared to similar patents?
Claims are moderately narrow, focusing on the core compound and specific uses, limiting overlap with broader patents.

4. When does the patent expire?
Projected expiration is between 2037 and 2040, depending on patent term adjustments.

5. Can other companies develop similar drugs around this patent?
Potentially, if they modify the compound sufficiently or find new therapeutic uses outside the claims' scope.

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References

1. U.S. Patent and Trademark Office. (2023). Patent 12,226,610.
2. International Patent Classification (IPC). (2023). Relevant codes for chemical compounds.
3. Patent landscape reports. (2022). Analysis of drug patent families and filings.

Drugs Protected by US Patent 12,226,610

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	12,226,610					METHOD OF ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA VIA AN ADDUCTOR CANAL BLOCK IN ADULTS
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011		RX	Yes	Yes	12,226,610					METHOD OF INCREASING THE AMOUNT OF TIME BEFORE POSTSURGICAL OPIOID MEDICATION IS ADMINISTERED TO A PATIENT BY ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011		RX	Yes	Yes	12,226,610					METHOD OF REDUCING POSTSURGICAL OPIOID CONSUMPTION BY ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes	12,226,610					METHOD OF ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA VIA AN ADDUCTOR CANAL BLOCK IN ADULTS
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes	12,226,610					METHOD OF INCREASING THE AMOUNT OF TIME BEFORE POSTSURGICAL OPIOID MEDICATION IS ADMINISTERED TO A PATIENT BY ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes	12,226,610					METHOD OF REDUCING POSTSURGICAL OPIOID CONSUMPTION BY ADMINISTERING BUPIVACAINE TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA

International Family Members for US Patent 12,226,610

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	120456947
European Patent Office	4611864
World Intellectual Property Organization (WIPO)	2024097347