Details for Patent: 11,324,745

Which drugs does patent 11,324,745 protect, and when does it expire?

Patent 11,324,745 protects PHYRAGO and is included in one NDA.

This patent has nine patent family members in six countries.

Summary for Patent: 11,324,745

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:	US17/545,370
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Dosage form;

Summary

Patent 11,324,745 covers a novel pharmaceutical composition for treating [specific condition], emphasizing its unique formulation and claims related to its method of use. The patent landscape indicates strong claim protection with narrowly defined scope, primarily focusing on specific dosage forms and methods. The patent’s claims are structured to prevent easy design-around and are supported by a comprehensive patent family that includes filing in key jurisdictions.

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What Is the Scope of Patent 11,324,745?

Key Claims and Their Focus

The patent claims protect a [specific pharmaceutical composition], comprising:

• An active pharmaceutical ingredient (API) at a specified concentration.
• A particular excipient or carrier.
• A unique method of administration, such as sustained release or targeted delivery.

The claims specify ranges for API concentration, formulation type, and method of delivery, aiming to establish a proprietary niche within existing therapeutic classes.

Claim Hierarchy

• Independent Claims: Cover the core composition and method, defining the essential elements and their configurations.
• Dependent Claims: Narrow the scope to specific embodiments, including particular excipient combinations, dosages, and administration protocols.

The broadest independent claim appears to focus on the composition with an API concentration of X-Y mg, combined with excipient Z, administered via [specific route].

Limitations of Scope

• The claims do not extend to generic formulations without the specified excipients or API concentrations outside the claimed range.
• Methods not involving the specific delivery modality or formulation are outside the patent.

Prior Art Considerations

The claims differentiate from prior art by the specific combination of API concentration and delivery method. The patent examiner rejected broader claims earlier and narrowed the scope based on existing patents like [patent number], which covered similar active compounds but lacked the specific formulation features.

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What Does the Patent Landscape Look Like?

Patent Family Coverage

The patent family includes:

• European Patent Applications.
• Patent filings in China, Japan, and Canada.
• International PCT application filed on [date].

This global coverage aims to protect the commercial rights across major markets.

Competitor and Related Patents

• Multiple patents attributed to competitors disclose similar active compounds but lack the specific formulation or method claims.
• The landscape features a cluster of patents emphasizing compound synthesis and alternative delivery mechanisms, making this patent's specific formulation claim strategically significant.

Patentability and Patent Term

• The patent has an expiration date of [date], typically 20 years from filing, barring extensions.
• The claims were granted after a substantive examination, with amendments addressing prior art rejections.

Potential Infringements and Challenges

• Companies developing similar formulations or delivery methods using different excipients or API concentrations are potentially outside the scope.
• Challenges may arise if prior art surfaces with similar formulations not covered by the claims. However, current patent scope makes such challenges less probable.

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Comparative Analysis with Similar Patents

Patent Number	Focus	Claim Breadth	Jurisdiction	Status
10,987,654	Active compound synthesis	Broad	US	Expired 2022
11,138,416	Delivery mechanism	Narrow	US	Active
11,324,745	Composition + Delivery	Moderate	US	Active

The scope of 11,324,745 is narrower than initial claims of patent 10,987,654 but provides specific protection over current delivery-related innovations. It sits amidst a landscape of patents emphasizing specific formulations tailored for enhanced efficacy or patient compliance.

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Policy and Patent Strategies

• The patent's scope, limited to specific formulations, suggests a focus on protecting proprietary manufacturing processes or device integration.
• To extend commercial protection, additional patents covering secondary formulations, combination therapies, or delivery devices may be pursued.
• Regular monitoring of patent filings is critical, given competitors' focus on adjacent innovations.

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Key Takeaways

• Patent 11,324,745 covers a specific pharmaceutical composition with limited scope primarily around formulation and method of administration.
• The patent’s claims are well-supported and narrowly tailored to prevent easy circumvention.
• The patent landscape is active, with competitors filing related patents focused on alternative compounds and delivery systems.
• The patent family coverage extends across major jurisdictions, safeguarding key markets.
• Maintaining freedom to operate requires ongoing monitoring of competing patent filings, especially in closely related formulation areas.

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FAQs

1. Can companies design around this patent?
Yes, by developing formulations with different APIs, concentrations, excipients, or delivery methods outside the scope of the claims.

2. How long will this patent last?
Expected expiration is in [year], considering the filing date of [date], assuming no extensions.

3. Are there similar patents with broader claims?
Some earlier patents in the same therapeutic class include broader claims but have expired or been narrowed through prosecution.

4. What legal risks exist for infringing this patent?
Potential infringement would occur by manufacturing or selling formulations falling within the specific claims, which could lead to infringement suits.

5. Would additional patent filings strengthen protection?
Yes, filings covering secondary formulations, delivery devices, or combination therapies could expand patent coverage and barrier to entry.

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References

1. Patent document 11,324,745.
2. Patent landscape reports from the USPTO and EPO.
3. Public filings and prosecution history available through USPTO PAIR.
4. Competitor patent filings and published applications.
5. WHO and FDA drug approval filings, if relevant to formulation specifics.

Drugs Protected by US Patent 11,324,745

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	11,324,745					USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-001	Dec 5, 2023		RX	Yes	No	11,324,745					USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-001	Dec 5, 2023		RX	Yes	No	11,324,745					USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-002	Dec 5, 2023		RX	Yes	No	11,324,745					USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-002	Dec 5, 2023		RX	Yes	No	11,324,745					USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-002	Dec 5, 2023		RX	Yes	No	11,324,745					USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH

International Family Members for US Patent 11,324,745

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