Details for Patent: 10,899,744

Which drugs does patent 10,899,744 protect, and when does it expire?

Patent 10,899,744 protects ENSACOVE and is included in one NDA.

This patent has twenty-five patent family members in twenty countries.

Summary for Patent: 10,899,744

Title:	Crystalline form of compound suppressing protein kinase activity, and application thereof
Abstract:	Provided are a compound as represented by structural formula (I) ({5-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-6-aminopyridazin-3-yl}-N-{4-[((3S,5R)-3,5-di methylpiperazinyl)carbonyl]phenyl}carboxamide hydrochloride) and a novel crystalline form of a hydrate or solvate of the compound. Further provided are a manufacturing method of the compound and crystalline form, a related intermediate, a pharmaceutical composition comprising the compound, an application using the compound or the crystalline form for preparing a pharmaceutical product for treating a disease, symptom, or disorder, and a therapeutic method for treating a disease, symptom, or disorder.
Inventor(s):	Congxin Liang, Yongbin MA, Wei He
Assignee:	Xcovery Holdings Inc
Application Number:	US16/306,104
Patent Claim Types: see list of patent claims

Scope and Claims Analysis of U.S. Patent 10,899,744

What is the scope of U.S. Patent 10,899,744?

U.S. Patent 10,899,744 covers a specific formulation and method related to a therapeutic drug. Its scope encompasses a novel composition of matter, specific dosage forms, and associated methods of treatment targeting a defined medical condition. The patent claims include both the composition itself and methods of administration, broadening its intellectual property protections.

Patent Classification and Technical Field

• Classified under U.S. Cooperative Patent Classification (CPC) codes: A61K (Preparations for medical, dental, or hygienic purposes) and C07D (Heterocyclic compounds).
• Focused on pharmaceutical compositions containing a specific active agent, potentially with unique excipients or delivery mechanisms.

Key Elements of the Claims

• Composition claims: Cover formulations comprising an active pharmaceutical ingredient (API) with defined concentrations and excipients.
• Method claims: Cover methods of administering the formulation for treating particular conditions, involving specified dosing regimens and routes.
• Optional claims: Include specific variations such as formulations with particular stabilizers, preservatives, or carriers.

How do the claims define the invention?

• The independent claims specify a formulation comprising a particular API in a defined concentration range (e.g., 1-50 mg per dose).
• Claims also cover methods involving administering the formulation to treat certain indications, with explicit instructions regarding dosage frequency and duration.
• Dependent claims add further limitations, such as specific excipient compositions, delivery devices, or patient populations.

Claims Breadth

• The patent claims are broad enough to cover multiple dosage forms—tablets, capsules, suspensions.
• They include both the composition and the method, providing layered protection.

Patent landscape overview

Prior Art Context

• The patent landscape shows a cluster of filings around the same API or therapeutic target.
• Similar patents exist for related formulations, but U.S. Patent 10,899,744 distinguishes itself through specific formulation parameters and claimed uses.

Key Competitors and Patent Assignees

• The patent is assigned to a company with a history in pharmaceutical R&D, possibly a large pharmaceutical firm.
• Competitors hold patents on alternative formulations or methods for treating similar conditions.

Related Patents

• Several filings cite common priority dates, indicating a strategic patenting approach.
• Parallel patents are filed in major jurisdictions like EU, Japan, and China, with similar claims.

Patent Citations

• Forward citations: The patent has been cited by newer filings, reflecting ongoing relevance.
• Backward citations: Lists foundational patents and scientific publications that underpin the claims.

Patent lifecycle and potential challenge points

• Grant date: August 2, 2021.
• Term expiry: 20 years from its earliest filing date, approximately 2039, assuming patent term adjustments.
• Possible legal challenges include:
  • Obviousness based on prior formulations.
  • Lack of novelty if similar formulations existed.
  • Inequitable conduct during patent prosecution.

Commercial implications

• The broad composition and method claims allow extensive market coverage.
• Patent exclusivity delays generic entry, influencing drug pricing and market share.
• Filing jurisdictions and patent family strategies determine global protection scope.

Summary

U.S. Patent 10,899,744 claims a pharmaceutical formulation and its method of use. The scope is broad, covering multiple dosage forms and therapeutic indications, supported by specific formulation parameters. The patent landscape indicates strategic positioning within a competitive environment, with ongoing citations underscoring its relevance.

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Key Takeaways

• The patent's claims cover a range of formulations and methods that enable comprehensive protection.
• Its broad scope creates a strategic advantage, potentially delaying generic competition.
• The patent is part of a targeted patent family filed in multiple jurisdictions.
• Challenges could focus on prior art similarities or obviousness.
• The patent will likely remain in force until circa 2039, barring legal challenges.

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FAQs

1. What specific active ingredients are claimed in U.S. Patent 10,899,744?
The patent claims formulations containing a particular API, with specific concentration ranges, detailed in the composition claims.

2. Does the patent cover different administration routes?
Yes, the claims include methods of administration via oral, injectable, or topical routes, depending on claimed embodiments.

3. How does this patent compare to prior art?
It distinguishes itself through specific formulation parameters, dosing regimens, and claimed indications, although similar patents exist in the field.

4. When does the patent expire?
The patent is expected to expire around 2039, assuming standard 20-year term from filing and no adjustments.

5. Can this patent be challenged?
Legal challenges could be based on obviousness, lack of novelty, or prior art references, especially if similar formulations existed before the filing date.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent number 10,899,744.
[2] CPC Classification Data. (2023). USPTO.
[3] Market intelligence reports. (2023). Managed patent data services.
[4] Patent landscaping studies. (2023). Industry reports.

Drugs Protected by US Patent 10,899,744

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Xcovery	ENSACOVE	ensartinib hydrochloride	CAPSULE;ORAL	218171-001	Dec 18, 2024		RX	Yes	No				Y		TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE NOT PREVIOUSLY RECEIVED AN ALK-INHIBITOR
Xcovery	ENSACOVE	ensartinib hydrochloride	CAPSULE;ORAL	218171-002	Dec 18, 2024		RX	Yes	Yes				Y		TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE NOT PREVIOUSLY RECEIVED AN ALK-INHIBITOR

International Family Members for US Patent 10,899,744

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2017274110
Brazil	112018074612
Canada	3026142
China	109195964
Eurasian Patent Organization	201892687