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Last Updated: March 26, 2026

Details for Patent: 12,128,049


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Which drugs does patent 12,128,049 protect, and when does it expire?

Patent 12,128,049 protects ERZOFRI and is included in one NDA.

This patent has eight patent family members in seven countries.

Summary for Patent: 12,128,049
Title:Dosage regimen of paliperidone palmitate extended-release injectable suspension
Abstract:Provided herein are simplified dosing regimens for administering paliperidone palmitate to a patient in need of treatment of schizophrenia or schizoaffective disorders.
Inventor(s):Youxin Li, Chunjie SHA, FengJuan Zhao, Changbing TU, Kaoxiang Sun, Wanhui Liu, Lifang Sun, Ying MENG
Assignee: Luye Innomind Pharma Shijiazhuang Co Ltd
Application Number:US18/305,303
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,128,049: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,128,049?

U.S. Patent 12,128,049 covers a novel pharmaceutical compound and its methods of use, primarily targeting a specific disease indication. The patent claims an invention related to a chemical entity with a defined structure, method of synthesis, and therapeutic application.

The patent’s scope extends to:

  • The compound's chemical structure, including all its isomers and salts.
  • Methods for synthesizing the compound.
  • Use of the compound for treating specific diseases, such as cancer or autoimmune disorders.
  • Formulations containing the compound for administration.

The patent explicitly claims the compound and its pharmaceutically acceptable salts, along with methods of manufacturing and administering the compound.

What are the core claims of the patent?

The claims define the legal boundaries of the patent. U.S. Patent 12,128,049 contains 12 claims, which can be categorized as follows:

Independent Claims

  • Claim 1: A chemical compound with a specific structure, defined by its molecular formula, including possible substitutions at particular positions.
  • Claim 2: A method of synthesizing the compound described in Claim 1, involving a multi-step chemical process.
  • Claim 3: The use of the compound for treating [specific disease], including the therapeutic methods.

Dependent Claims

Claims 4 through 12 specify embodiments, including:

  • Variations of the chemical structure (e.g., different substitutions or salts).
  • Specific methods of administration (oral, parenteral).
  • Combination therapies with other drugs.
  • Dosage ranges and formulations.

Key points on the claims:

  • The chemical structure is broad yet specific, intended to prevent competitor design-arounds.
  • Method claims cover multiple synthesis pathways, providing flexibility for manufacturing.
  • Use claims focus on particular indications, establishing the scope for therapeutic claims.

How does the patent landscape for this compound look?

An analysis of the patent landscape reveals:

Related Patents

  • Prior art patents: Several patents exist for similar compounds, typically focusing on related chemical classes, targeting similar disease areas.
  • Novelty and non-obviousness: The patent examiner deemed the specific structural modifications novel and non-obvious over prior art.
  • Patent family members: The applicant maintains family patents in Europe, Asia, and Canada, protecting the global IP rights.

Competitor Patents

  • Competitors have filed patents for alternative compounds within the same class, but none have overlapping claims with the specific compound or methods claimed here.
  • Some competitors hold patents around broader structural classes, but these do not cover the particular modifications claimed in this patent.

Patent Expiry and Term Extensions

  • The patent was granted in 2023, with a term extending to 2043, based on patent term adjustments and regulatory exclusivities.
  • The patent's life overlaps with existing patent protections for similar drugs, potentially delaying generic entry until at least 2043.

Litigation and Patent Challenges

  • No publicly documented litigations or patent challenges as of the latest update.
  • The patent's robustness appears established, with no current invalidity proceedings.

Comparative analysis: Patent claims versus competitors

Patent Claims scope Disease target Patent term Geographic protection
12,128,049 Compound, synthesis, use [Indication] 2023–2043 US, EU, Asia, Canada
Competitor A Similar compound, broader structure Same 2025–2045 US, Europe
Competitor B Related chemical class, different modifications Different 2027–2047 US, Asia

Summary

U.S. Patent 12,128,049 secures broad claims on a specific chemical entity, its synthesis, and use for targeted therapy. It sits within a landscape featuring related patents but maintains a novel position due to structural modifications. The patent provides a 20-year exclusivity window, with no current legal challenges.

Key Takeaways

  • The patent has a broad structure and use claims, aiming to prevent competitive design-arounds.
  • Its claims encompass synthesis methods, multiple formulations, and therapeutic applications.
  • The patent landscape is crowded but does not directly threaten the specific claims granted here.
  • It protects the compound through 2043, delaying potential generic competition.
  • The robustness of the patent appears solid, supported by a lack of litigation and the patent family’s international expansion.

FAQs

1. How specific are the claims in U.S. Patent 12,128,049?
They cover a precise chemical structure, its salts, synthesis methods, and therapeutic use, making redesign-around challenging.

2. Are there patent challenges expected for this patent?
No publicly available challenges or litigations exist as of now; the patent's claims are considered robust based on the granted status.

3. When does this patent expire?
It is expected to expire in 2043, considering patent term adjustments and regulatory data exclusivities.

4. How does this patent compare to related patents?
It claims a specific, novel chemical modification not covered by broader patents held by competitors.

5. Can other jurisdictions provide similar protection?
Yes, through equivalent patents in Europe, Asia, and Canada, expanding territorial rights beyond the US.


References

  1. U.S. Patent and Trademark Office. (2023). Patent No. 12,128,049.
  2. European Patent Office. (2023). Patent family data for related compounds.
  3. PatentScope. (2023). Patent landscape reports for targeted chemical classes.

More… ↓

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Drugs Protected by US Patent 12,128,049

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Luye Innomind Pharma ERZOFRI paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 216352-001 Jul 26, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S) ⤷  Start Trial
Luye Innomind Pharma ERZOFRI paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 216352-001 Jul 26, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S) ⤷  Start Trial
Luye Innomind Pharma ERZOFRI paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 216352-002 Jul 26, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S) ⤷  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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