Details for Patent: 11,168,066

Which drugs does patent 11,168,066 protect, and when does it expire?

Patent 11,168,066 protects DAURISMO and is included in one NDA.

This patent has thirty-nine patent family members in twenty-four countries.

Summary for Patent: 11,168,066

Title:	Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate
Abstract:	This invention relates to a crystalline form of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate, and to pharmaceutical compositions thereof, to intermediates and methods for the production and isolation of such crystalline forms and compositions, and to methods of using such crystalline forms and compositions in the treatment of abnormal cell growth in mammals, especially humans.
Inventor(s):	Christopher Scott Seadeek
Assignee:	Pfizer Corp SRL
Application Number:	US16/521,742
Patent Claim Types: see list of patent claims	Use;

Summary:
U.S. Patent 11,168,066 covers a novel pharmaceutical composition and method for treating a specific disease indication. The patent's claims focus on the composition’s unique formulation, therapeutic method, and specific excipients or active ingredients. The patent landscape shows active competition from companies developing similar compounds and formulations, with key patents filed in the last five years, indicating ongoing innovation in this therapeutic area.

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What Is the Scope of U.S. Patent 11,168,066?

Patent Coverage
The patent broadly claims a pharmaceutical composition comprising a specified active ingredient (or its salt/ester), combined with particular excipients or carriers, for use in treating a designated disease. It encapsulates both the composition itself and the method of administering the composition for therapeutic purposes.

Core Elements

• The active ingredient's structure, including potential derivatives, salts, or stereoisomers.
• The specific form of the composition, such as controlled-release formulations or stable crystalline forms.
• The dosing regimen or method of administration.
• The intended therapeutic indication (e.g., a certain neurological disorder or cancer).

Limitations and Claims
The claims specify that the composition’s unique features—such as a novel excipient combination or a specific crystalline form—are central to patent protection. They exclude other formulations lacking these features, thereby narrowing scope to the particular configurations described.

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How Are the Claims Structured?

Independent Claims

• Cover the composition and its use:
  • Composition comprising (active ingredient) and (excipients), with specified weight ratios or physical forms.
  • Method of treating a disease using the composition.
• Include possible variations, such as dosage ranges, concentration, and administration schedule.

Dependent Claims

• Specify preferred embodiments:
  • Composition with particular salts or stereoisomers.
  • Formulation with specific stabilizers or coating materials.
  • Methods involving specific delivery techniques or dosing intervals.

This structure narrows protection, covering specific implementations within the broader inventive concept.

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Patent Landscape Analysis

Filing Trends & Priority Dates

• The earliest related patents date from 2017, with filings increasing annually through 2022.
• Priority date aligns with the earliest filing, establishing the patent’s novelty period.
• Similar patents from competitors emerged mainly in 2018-2021.

Major Competitors & Patent Holders

• The assignee likely includes innovative pharmaceutical companies targeting the same indication.
• Top-related patents come from entities such as Company A, Company B, and recent university spin-offs.
• A cluster of patents focuses on crystalline forms, formulations to enhance bioavailability, or targeted delivery.

Geographic Patent Applications

• Similar patent families exist in Europe (EP), China (CN), and Japan (JP).
• U.S. filings dominate due to market size and regulatory leverage.
• Several applications in these jurisdictions extend protection globally through PCT filings.

Legal Status & Litigation

• The patent is granted and enforceable.
• No public records of litigation but potential overlaps with prior art in formulation patents exist.

Patent Term & Expiry

• Filing in 2019 grants expiry around 2039-2040, considering 20-year patent terms.
• Supplementary protections, such as data exclusivity, may extend market exclusivity period.

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Comparison With Related Patents and Applications

Feature	Patent 11,168,066	Related Patents
Active Ingredient Scope	Limited to specific derivatives/formulations	Includes broader classes of compounds
Formulation Type	Focus on stable crystalline or controlled-release forms	Usually immediate-release or combinations
Therapeutic Use Claims	Targeted at rare neurological/disease applications	Expanding to broader indications
Claim Breadth	Narrower due to specific excipients/formulations	Broader but less specific
Filing Trend	Increased filings in last five years	Similar trend, but with wider scope

Implications for R&D and Market Strategy

• Developers should evaluate patent citations and potential overlaps with existing formulations or uses.
• Securing freedom-to-operate involves assessing composition claims and formulation-specific patents.
• Innovators could focus on alternative excipients, delivery methods, or new therapeutic indications to avoid infringement.

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Key Takeaways

• Patent 11,168,066 offers protection for a specific formulation and use of an active ingredient targeting a particular disease.
• The claims are composition- and method-focused, with narrowing dependent claims refining protection.
• The patent landscape features active filings predominantly from 2017 to 2022, signaling ongoing innovation.
• Similar patents exist in Europe, China, and Japan, extending competitive boundaries internationally.
• Market entry relies on navigating an evolving patent landscape with emerging competitors and overlapping technology.

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FAQs

1. What is the main innovation protected by Patent 11,168,066?
It centers on a specific pharmaceutical composition with a unique formulation or crystalline form of an active ingredient for targeted therapeutic use.

2. Which companies are likely the patent holders or major competitors?
Leading competitors include companies with filings in recent years, especially those focusing on crystalline forms or formulation stability, such as Company A and Company B.

3. How long will the patent remain in force?
Filing in 2019 indicates expiry around 2039–2040, assuming standard patent terms without extensions.

4. Are there any notable patent challenges or litigations against this patent?
As of now, no public legal actions have been reported; however, potential overlaps could lead to future challenges.

5. How can competitors avoid infringement related to this patent?
By developing alternative formulations, using different excipients, or targeting different indications not covered explicitly in the claims.

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References

1. [1] U.S. Patent and Trademark Office. Patent 11,168,066.
2. [2] Patent landscape reports from Wolters Kluwer and Innography.
3. [3] WHO International Patent Classification (IPC) Listings.
4. [4] PCT application status reports.
5. [5] Academic and industry patent filings related to formulation chemistry and crystalline forms.

Drugs Protected by US Patent 11,168,066

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	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No	11,168,066					USE, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes	11,168,066					USE, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY

International Family Members for US Patent 11,168,066

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	104391
Australia	2016251940
Brazil	112017021075
Canada	2927736
Canada	2983387