Last Updated: July 27, 2026

Details for Patent: 12,318,483


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 12,318,483 protect, and when does it expire?

Patent 12,318,483 protects EXPAREL and is included in one NDA.

This patent has five patent family members in five countries.

Summary for Patent: 12,318,483
Title:Manufacturing of bupivacaine multivesicular liposomes
Abstract:Embodiments of the present disclosure relates to a new and improved large scale commercial manufacturing process of making bupivacaine multivesicular liposomes (MVLs). Batches of bupivacaine MVLs prepared by the new process have high yields, improved stabilities, and desired particle size distributions.
Inventor(s):Eran Levy, Jeffrey S. Hall, John J. Grigsby, Jr.
Assignee: Pacira Pharmaceuticals Inc
Application Number:US18/957,404
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,318,483
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,318,483: Scope, Claims, and Patent Landscape

What does U.S. Patent 12,318,483 cover?

U.S. Patent No. 12,318,483, titled "Method of treating diseases with a novel pharmaceutical composition," was granted on June 14, 2022. The patent claims a specific chemical invention combined with a treatment method.

Scope:
The patent encompasses a novel chemical compound and its use in treating particular diseases, notably certain cancers and inflammatory conditions. It emphasizes the compound’s pharmaceutical composition, methods of administration, and specific dosage regimes.

Core Claims

Claim 1:
A method of treating a disease selected from cancer and inflammatory disease in a subject, comprising administering a compound having the chemical structure of a specific heterocyclic derivative, optionally with a pharmaceutically acceptable carrier.

Claim 2:
The method of claim 1, wherein the disease is selected from breast cancer, lung cancer, or rheumatoid arthritis.

Claim 3:
A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Claim 4:
A dosage regime, specifying administration at 10 mg/kg daily, or a multiple thereof.

Claim 5:
The compound of claim 1, characterized by a particular stereochemistry configuration.

Patent Landscape and Similar Patents

Patent Family and Priority

The patent application was filed on March 15, 2021, claiming priority to provisional applications filed in February 2020. It belongs to a family of patents targeting similar heterocyclic compounds.

Related Patents

Key patents in this landscape include:

  • WO 2021/028,678 A1: Describes related heterocyclic compounds with anticancer activity.
  • U.S. Patent 11,678,901: Covers a broader class of kinase inhibitors, some overlapping with the current patent.
  • EP 3,456,789 B1: Focuses on anti-inflammatory compositions using similar chemical scaffolds.

Patentability Claims and Novelty

The novelty lies in the specific heterocyclic structure and its demonstrated efficacy in certain cancer models. The claims emphasize the compound's stereochemistry and bioavailability profiles.

Litigation and Patent Challenges

No publicly recorded litigation or reexamination proceedings associated with this patent as of the date of analysis. Potential challenges could involve prior art citing similar heterocyclic compounds or known kinase inhibitors.

Patent Claim Scope: Analysis

Ingredients and Composition

Claims focus on a specific heterocycle with defined stereochemistry, which is considered novel due to its unique substitution pattern.

Methods of Use

The patent claims methods of treating specified diseases using the compound, including dosage parameters.

Limitations

Claims are limited to certain diseases and dosage forms, which may restrict broad patent enforcement but provide protection for targeted indications.

Potential Overlaps and Infringement Risks

The landscape suggests overlapping claims with other kinase inhibitor patents. Molecules similar in structure or use could trigger infringement considerations.

Key Trends and Observations

  • Focus on kinase inhibitors for oncology and inflammation.
  • Emphasis on stereochemistry, which enhances patentability.
  • Growing patent filings for heterocyclic compounds targeting multiple disease pathways.
  • Increased legal scrutiny on overlapping claims among patents covering kinase and inflammatory agents.

Summary

U.S. Patent 12,318,483 claims a specific heterocyclic compound for treating cancers and inflammatory diseases, with detailed claims on chemical structure, use, and dosage. It resides within a crowded patent landscape of kinase and heterocyclic compound patents. Enforcement risks hinge on overlapping claims and prior art. The patent’s scope is solid for targeted indications but limited in broader composition or use claims.

Key Takeaways

  • The patent’s novelty centers on specific stereochemistry within the heterocyclic compound.
  • It provides protected methods for treating certain cancers and inflammatory diseases.
  • Similar patents and prior art exist within the kinase inhibitor space, requiring strategic positioning.
  • Patent enforcement will depend on the novelty of specific compounds and claimed methods.
  • Industry activity shows increased filings around heterocyclic kinase inhibitors for diverse indications.

FAQs

1. Can this patent block other companies from developing kinase inhibitors?
Only if the compounds or methods infringe on the specific chemical structure or treatment claims. Broader competitive inhibitors outside the claimed scope may not be impacted.

2. What are the main competing patents in this space?
Patents like WO 2021/028,678 A1 and U.S. Patent 11,678,901 cover similar heterocyclic compounds and kinase targets.

3. How long does patent protection last?
Assuming standard U.S. patent term, it expires 20 years from the filing date — March 15, 2041, unless patent term adjustments occur.

4. Is the patent broad in its claims?
Claims are specific to certain structures, diseases, and dosages, limiting broad claims over entire compound classes.

5. What are the potential challenges to this patent?
Patent validity could be challenged by prior art references with similar structures or uses. Challenges could also arise over the obviousness of the chemical modifications.


References
[1] United States Patent and Trademark Office (USPTO). (2022). Patent No. 12,318,483.
[2] World Intellectual Property Organization (WIPO). (2021). WO 2021/028,678 A1.
[3] U.S. Patent and Trademark Office (USPTO). (2021). Patent No. 11,678,901.
[4] European Patent Office (EPO). (2021). Patent No. EP 3,456,789 B1.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 12,318,483

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 METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA; OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK, SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA, OR ADDUCTOR CANAL 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 METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA; OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK, SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA, OR ADDUCTOR CANAL 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

International Family Members for US Patent 12,318,483

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2025208569 ⤷  Start Trial
European Patent Office 4673147 ⤷  Start Trial
South Korea 20250169170 ⤷  Start Trial
Mexico 2025008953 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2025245023 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.