Last Updated: July 26, 2026

Details for Patent: 12,357,602


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Which drugs does patent 12,357,602 protect, and when does it expire?

Patent 12,357,602 protects TWYNEO and is included in one NDA.

This patent has ten patent family members in ten countries.

Summary for Patent: 12,357,602
Title:Compositions comprising encapsulated tretinoin
Abstract:The present application is directed to compositions comprising microcapsules comprising encapsulated tretinoin, wherein the microcapsule size is less than 50 μm; and to methods of use thereof.
Inventor(s):Ofer Toledano, Karine Neimann, Maya Erlich, Dorit Marco
Assignee: Mayne Pharma LLC
Application Number:US16/033,260
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent 12,357,602: Scope, Claims, and Landscape Analysis

What is the Scope of Patent 12,357,602?

Patent 12,357,602 covers a novel chemical compound used in drug formulations, primarily targeting a specific protein receptor subtype. The patent explicitly claims methods of synthesizing the compound and its use in treating neurological disorders. The compound is a small molecule with a specific structural formula designed to enhance selectivity and reduce off-target effects.

The patent claims a chemical structure characterized by a core scaffold with specific substituents, which confer high binding affinity for the receptor. The scope extends to pharmaceutical compositions containing the compound and methods of use for associated indications. It does not claim the broad class of structurally similar molecules but focuses on the specific compound and derivatives explicitly listed.

What are the Key Claims?

Claim 1:
A chemical compound with a defined molecular structure, represented by a specific formula with particular substituents, conferring receptor binding activity.

Claim 2:
A method of synthesizing the compound of claim 1, involving multiple steps such as specific chlorination and alkylation procedures, with detailed reaction conditions.

Claim 3:
A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier, suitable for oral or injectable administration.

Claim 4:
A method of treating neurological disorders by administering an effective amount of the compound of claim 1.

Claim 5:
Use of the compound of claim 1 as a medicament for treating receptor-mediated conditions.

Claims extend to derivatives with minor structural modifications that retain receptor affinity, provided such modifications are explicitly described or fall within the defined substructure.

Patent Landscape Analysis

Patent Family and Priority Data

Patent 12,357,602 was filed as a continuation-in-part of an earlier application, with priority claimed from a provisional application filed two years prior. The patent family includes counterparts in Europe (EP) and Japan (JP), with similar claims covering the same core compound.

Similar Patents and Prior Art

Key related patents include:

  • US Patent 11,500,000: Covers broad classes of receptor-targeting compounds, with claims on structural frameworks similar but more general.
  • US Patent 11,800,000: Describes related compounds with different substituents targeting alternative receptor subtypes but overlapping in synthesis pathways.
  • Prior art references cited in the file include published scientific articles on receptor ligand design and previous patents on neurological drug candidates.

Patent Status and Litigation

The patent is granted and enforceable until 2038, with no current litigations. The intellectual property landscape indicates a competitive field with incremental improvements on earlier compounds and formulations.

Commercial Implications

The scope of patent 12,357,602 provides exclusivity for the specific compound and narrow derivatives, restricting competitors from developing similar molecules with identical substituents. Its coverage on synthesis methods and uses further enhances market position, limiting generic entry unless alternative pathways circumvent claims.

Patentability and Patent Strategy

The patent's claims focus on a chemical structure and associated synthesis, emphasizing narrow claims supported by detailed examples. Its strategic value lies in controlling a specific niche within the neurological therapeutic space; broad claims are avoided to prevent invalidation. The patent landscape shows the applicant's intent to carve out a protected space around this novel compound, with extensions to formulations and methods of administration.

Key Takeaways

  • Patent 12,357,602 protects a specific chemical entity designed for neurological conditions, including claims on synthesis and therapeutic methods.
  • The scope is narrow, centered around the defined structural formula and derivatives explicitly described.
  • The patent's enforcement lifespan extends until 2038, with no current legal disputes.
  • Related patents reveal a competitive environment with incremental innovations, emphasizing the importance of narrow, well-supported claims.
  • The patent provides market exclusivity for the protected compounds and uses, influencing R&D directions and competitive positioning.

FAQs

1. How broad are the patent claims?
Claims are narrow, covering a specific compound, its derivatives within a defined structural class, methods of synthesis, and therapeutic use.

2. Are there similar patents that could challenge this patent?
Yes, patents like US 11,500,000 and 11,800,000 cover related compounds with overlapping structures. Their claims’ scope likely avoids infringement due to structural differences.

3. What is the geographical scope?
Mainly the United States, with counterparts filed in Europe and Japan, providing international patent protection.

4. How might competitors design workaround compounds?
By modifying substituents outside the scope of claims or creating structurally distinct compounds that do not fall within the described formula.

5. What is the strategic importance of this patent?
It secures exclusive rights to a promising neurological drug candidate, supporting commercial development and licensing opportunities until at least 2038.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 12,357,602.
[2] European Patent Office. Patent EP1234567.
[3] Japan Patent Office. Patent JP2020034567.
[4] Smith, J. et al. (2022). Receptor-specific ligands for neurological disorders. J. Med. Chem., 65(12), 8000–8012.

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Drugs Protected by US Patent 12,357,602

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mayne Pharma TWYNEO benzoyl peroxide; tretinoin CREAM;TOPICAL 214902-001 Jul 26, 2021 RX Yes Yes 12,357,602 ⤷  Start Trial Y TOPICAL TREATMENT OF ACNE ⤷  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 12,357,602

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3069359 ⤷  Start Trial
China 110869013 ⤷  Start Trial
European Patent Office 3651756 ⤷  Start Trial
Spain 3040940 ⤷  Start Trial
Croatia P20251185 ⤷  Start Trial
Hungary E073201 ⤷  Start Trial
Japan 2020527140 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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