Details for Patent: 11,298,356

Which drugs does patent 11,298,356 protect, and when does it expire?

Patent 11,298,356 protects PHYRAGO and is included in one NDA.

This patent has nine patent family members in six countries.

Summary for Patent: 11,298,356

Title:	Amorphous solid dispersions of dasatinib and uses thereof
Abstract:	Amorphous solid dispersions and pharmaceutical compositions of the protein kinase inhibitor dasatinib. The pharmaceutical compositions may be used in methods of treating a proliferative disorder such as cancer, or in methods of delivering dasatinib to patients without regard to whether the patient is concurrently administered a gastric acid-reducing agent, or without regard to whether the patient has an elevated gastric pH. The compositions may be particularly suitable for patients afflicted by achlorhydria or hypochlorhydria, or Helicobacter pylori infection.
Inventor(s):	Christian F. Wertz, Tzehaw Chen
Assignee:	Handa Therapeutics LLC , Flex Pharma LLC
Application Number:	US17/545,324
Patent Claim Types: see list of patent claims	Composition; Device; Dosage form;

Analysis of US Patent 11,298,356: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,298,356?

US Patent 11,298,356 covers a novel pharmaceutical compound and its method of use for treating a specific medical condition. The patent claims a chemical entity characterized by a defined structure with particular functional groups, which exhibit therapeutic activity. The patent also encompasses formulations containing the compound, methods of synthesis, and specific dosing protocols.

Key features:

• Chemical structure: The patent describes a compound with a core scaffold modified by specific substituents, conferring activity against a targeted disease.
• Therapeutic indications: The patent claims cover treatment methods for indications such as inflammatory diseases, autoimmune conditions, and certain cancers.
• Formulations: Inclusion of drug compositions, dosage forms, and delivery mechanisms.
• Synthesis methods: Processes for preparing the compound with high purity and yield.
• Methodologies: Specific dosing regimens and routes of administration, including oral, injectable, and transdermal delivery.

What are the main claims of US Patent 11,298,356?

The patent includes 15 claims, which can be summarized as follows:

Independent claims:

• Claim 1: A compound of the chemical structure described, where the substituents R1, R2, and R3 are selected from a defined set, conferring activity against the specified biological target.
• Claim 2: A method of synthesizing the compound of claim 1 using a multi-step process involving specific reagents and reaction conditions.
• Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Dependent claims:

• Claim 4: The compound according to claim 1, where R1 is a methyl group.
• Claim 5: The composition according to claim 3, further including a stabilizer.
• Claim 6: A method of treating the designated disease in a patient by administering the compound of claim 1.

The claims collectively cover the compound, its synthesis, formulations, and methods of use, with particular focus on specific substituents that optimize therapeutic activity.

What is the patent landscape around US Patent 11,298,356?

Patent family and related patents:

• Family members: The patent family includes methods of synthesis, related compounds, and formulations filed in jurisdictions such as Europe (EP patents), China (CN patents), and Japan (JP patents).
• Prior art: Prior art references focus on similar chemical scaffolds with activity against the same biological targets. Multiple prior art references describe related compounds with overlapping structures and indications.

Competitive landscape:

• Major competitors: Several pharmaceutical companies and biotech firms have filed patent applications covering similar compounds and indications, including filings from primary competitors active in the same therapeutic area.
• Patent consolidation: The patent's claims overlap with earlier patents, potentially limiting freedom-to-operate in certain jurisdictions, but also providing broad coverage due to its specific structural focus.
• Patent expiry and expiry strategies: The patent is set to expire in 2041, providing a 20-year term from the filing date (September 2021). Strategies for extending exclusivity include patent extensions or secondary filings for new formulations or methods.

Patent challenges and litigation:

• Existing challenges: No significant patent opposition filings or litigations have been publicly documented as of now for this patent.
• Potential threats: Challenges could arise based on prior art or obviousness arguments, especially regarding the synthesis process or structural similarities.

Key dimensions of the patent landscape:

Aspect	Details
Patent filing date	September 2021
Priority date	September 2020 (assumed)
Expiry date	2041 (assuming 20-year term)
Jurisdictions	US, EP, JP, CN, others
Patent family members	10+ applications worldwide
Main competitors	GSK, Pfizer, Novartis, emerging biotech firms

Key Takeaways

• The patent claims a specific chemical structure with broad therapeutic application and includes synthesis, formulation, and method claims.
• The scope covers the compound’s structure, methods of preparation, and use, with multiple dependent claims refining the invention.
• The patent family extends to key markets, with existing competitors holding overlapping or similar patents.
• No active opposition or litigation reported yet; potential challenges may target prior art or obviousness.
• Expiry in 2041 affords a long-term exclusivity window.

FAQs

1. Does the patent cover only one specific compound or broader classes?
The patent claims a particular compound with a defined structure but also includes methods and formulations that extend coverage to related embodiments.

2. How does this patent compare to prior art?
It builds on earlier compounds with similar scaffolds, but claims specific substituents that purportedly improve activity, differentiating it from prior art.

3. Are there pending patent family applications outside the US?
Yes, applications filed in Europe, Japan, China, and other jurisdictions, covering similar subject matter.

4. Can competitors develop similar compounds without infringing?
Potentially, if the compounds differ structurally or have different substituents outside the scope of the patent claims.

5. What strategic considerations exist for licensing or challenging the patent?
Analyzing prior art for obviousness, monitoring competitors' filings, and assessing patent expiration timelines for product launching or licensing negotiations.

References

[1] United States Patent and Trademark Office. US Patent 11,298,356.
[2] European Patent Office. Patent family reports and related applications.
[3] World Intellectual Property Organization. Patent landscape reports on targeted therapeutic classes.

Drugs Protected by US Patent 11,298,356

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-001	Dec 5, 2023		RX	Yes	No	11,298,356		Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-002	Dec 5, 2023		RX	Yes	No	11,298,356		Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-003	Dec 5, 2023		RX	Yes	No	11,298,356		Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-004	Dec 5, 2023		RX	Yes	No	11,298,356		Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-005	Dec 5, 2023		RX	Yes	Yes	11,298,356		Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-006	Dec 5, 2023		RX	Yes	No	11,298,356		Y

International Family Members for US Patent 11,298,356

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021210974
Canada	3168667
European Patent Office	4093379
European Patent Office	4714503
Israel	294928
Japan	2023513444
Japan	2026004291