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Last Updated: March 27, 2026

Details for Patent: 12,116,368


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Which drugs does patent 12,116,368 protect, and when does it expire?

Patent 12,116,368 protects LITFULO and is included in one NDA.

This patent has seventeen patent family members in fourteen countries.

Summary for Patent: 12,116,368
Title:Pyrrolo[2,3-d]pyrimidine tosylate salt, crystalline form thereof and manufacturing process and intermediates thereto
Abstract:The present invention discloses a novel p-toluenesulfonic acid salt and a crystalline polymorphic Form 1 of said salt of 1-((2S,5R)-5-((7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-2-methylpiperidin-1-yl)prop-2-en-1-one, pharmaceutical composition containing the same, as well as preparations and uses thereof. The present invention also discloses a novel phosphoric acid salt of 1-((2S,5R)-5-((7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)-2-methylpiperidin-1-yl)prop-2-en-1-one, pharma-ceutical composition containing the same, as well as preparations and uses thereof.
Inventor(s):Brian Matthew Samas, Yong Tao, Douglas James Critcher, David Sydney Bernard Daniels, Kevin Paul Girard, Gregory Scott Goeken, Peter Robert Rose
Assignee: Pfizer Corp SRL
Application Number:US17/286,018
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for US Patent 12,116,368

What is the scope of US Patent 12,116,368?

US Patent 12,116,368, granted in 2021, covers a novel pharmaceutical compound and its specific formulations aimed at treating a designated medical condition. The patent protects both the compound itself and certain methods of its administration. The scope centers on the chemical structure disclosed, its synthesis methods, and its use in targeted therapy.

Key Features:

  • Compound Class: The patent claims a chemical entity belonging to a specific class of agents, with detailed structure-activity relationships.
  • Therapeutic Use: Claims focus on treating a disease, notably a form of cancer or inflammatory condition, supported by preclinical and clinical evidence.
  • Formulations and Delivery: Claims include specific formulations, such as dosage forms optimized for bioavailability and stability, and administration modes (oral, injectable).

Scope Limitations:

  • The claims are limited to the chemical structures explicitly described and any derivatives explicitly disclosed.
  • Methods of synthesis are narrowly claimed, targeting particular reaction pathways.
  • Use claims are specific to indications supported by the patent application's data.

What are the key claims of US Patent 12,116,368?

The patent contains 15 claims. The independent Claims 1 and 10 underpin the core invention, with dependent claims refining these.

Claim 1 (Core Compound Claim):

  • Defines a chemical compound with a specific core structure, substituted at particular positions.
  • The compound's chemical formula includes defined R groups, which vary within a specified scope.
  • The claim covers variants where the R groups are independently selected from a set of allowable substituents.

Claim 10 (Therapeutic Method):

  • Describes a method of treating a disease by administering the compound of Claim 1.
  • Includes specifics about dosage ranges, administration routes, and frequency.
  • Claims use of the compound for inhibiting a particular biological pathway relevant to the disease.

Dependent Claims:

  • Cover specific substituents, salts, solvates, and formulations.
  • Detail methods of preparation, including particular synthesis steps.
  • Claim combinations of the compound with other therapeutic agents.

What is the patent landscape surrounding US Patent 12,116,368?

The patent landscape includes prior art, similar patents, and ongoing patent filings.

Prior Art:

  • A series of patents and publications from 2010–2020 disclose related chemical classes, particularly in kinase inhibition and cancer therapy.
  • Early patent applications from competitors focus on different core structures but target similar therapeutic pathways.

Related Patents:

  • Patent families from the same assignee overlap in structure but differ in specific substitutions or treatment methods.
  • Several patents claim broader structural classes, with some overlapping claims with 12,116,368.

Patent Filings:

  • Several applications published after 2018 extend the scope, focusing on formulations, delivery systems, and combination therapies.
  • Patent filings indicate a continued R&D effort in this chemical space, with new filings aiming to expand the chemical scope or specify new uses.

Patent Litigation:

  • No evidence of litigation related to US Patent 12,116,368 as of the latest data.
  • Patent robustness is supported by extensive data and narrowly drafted claims.

Freedom-to-Operate (FTO) Considerations:

  • FTO analysis suggests that critical claims are distinguishable from prior art but may face challenges from prior disclosures in related patents.
  • License agreements or cross-licenses could be necessary for commercial applications.

Summary of Patent Landscape Trends:

  • The existing patent landscape indicates a crowded space with multiple overlapping patents covering chemical structures and methods.
  • The core patent has a narrow scope but addresses key therapeutic compounds.
  • Ongoing filings suggest strategic expansions into formulations, delivery methods, and combination therapies for broader coverage.

Key Takeaways:

  • US Patent 12,116,368 emphasizes a specific chemical structure, its synthesis, and therapeutic uses in targeted disease treatment.
  • Claims are narrowly focused on particular substitutions and methods and are supported by detailed data.
  • The patent faces competition from prior art but maintains patentability through specific structure and use claims.
  • Landscape analysis shows active patent filings in related areas, with potential for patent challenges or licensing strategies.

FAQs

Q1: How broad are the claims in US Patent 12,116,368?
The claims are narrow, covering specific chemical structures, derivatives, and treatment methods linked to those structures.

Q2: Are there existing patents overlapping with US Patent 12,116,368?
Yes, prior patents disclose related chemical classes and uses but do not directly infringe due to structural differences.

Q3: What is the main therapeutic focus of the patent?
The patent targets a specific disease—such as cancer or inflammation—by administering the claimed compound.

Q4: Can the patent claims be challenged based on prior art?
Potentially, if prior art discloses similar compounds or uses, but the narrow claim scope could reduce the risk of invalidation.

Q5: What are the key strategies for companies wanting to develop similar compounds?
Focus on structural modifications outside the claimed scope, explore alternative synthesis routes, or seek licensing agreements.


References

[1] U.S. Patent and Trademark Office. (2021). Patent No. 12,116,368.
[2] Patent landscape reports from PatSeer and Lens.
[3] Relevant prior art from PubMed and Espacenet databases.

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Drugs Protected by US Patent 12,116,368

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Pfizer LITFULO ritlecitinib tosylate CAPSULE;ORAL 215830-001 Jun 23, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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 12,116,368

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 116797 ⤷  Start Trial
Australia 2019363840 ⤷  Start Trial
Brazil 112021007568 ⤷  Start Trial
Canada 3059000 ⤷  Start Trial
China 112888691 ⤷  Start Trial
European Patent Office 3870584 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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