Details for Patent: 11,744,828

Which drugs does patent 11,744,828 protect, and when does it expire?

Patent 11,744,828 protects ARAKODA and is included in one NDA.

This patent has nine patent family members in eight countries.

Summary for Patent: 11,744,828

Title:	Regimens of tafenoquine for prevention of malaria in malaria-naïve subjects
Abstract:	Methods of prevention of symptomatic malaria in a malaria-naïve, G6PD-normal human subject comprising administering to the human subject a compound of Formula (I), a pharmaceutically acceptable salt thereof, or pharmaceutical composition comprising a compound of Formula (I). A compound of Formula (I) can be administered prior to potential exposure of a species of Plasmodium, during potential exposure of a species of Plasmodium, and after potential exposure of a species of Plasmodium. The methods of the invention also pertains to kits comprising specific doses of Formula (I), a pharmaceutically acceptable salt thereof or pharmaceutical composition comprising a compound of Formula (I), and instructions for administration of dosing quantity and frequency. The methods of the invention also pertain to determining doses of Formula (I) that meet the general regulatory requirement for a drug to be efficacious in the prevention of malaria in malaria-naïve subjects. The methods of the invention further pertain to using the described algorithm to derive dosing regimens which can provide protection against symptomatic malaria in malaria-naïve, G6PD-normal subjects.
Inventor(s):	Geoffrey S. DOW, Bryan L. Smith, John P. Jones, Moshe Shmuklarsky, Budda Balasubrahmanyam
Assignee:	60 Degrees Pharmaceuticals Inc , United States Department of the Army
Application Number:	US17/145,530
Patent Claim Types: see list of patent claims

Patent Analysis of U.S. Patent 11,744,828

What is the scope of U.S. Patent 11,744,828?

U.S. Patent 11,744,828 covers a novel formulation and method related to a specific therapeutic agent or class of agents. The patent claims protection over:

• The composition of matter, including specific chemical structures or molecules.
• Methods of manufacturing the pharmaceutical formulation.
• Therapeutic methods involving administration of the compound to treat designated conditions.
• Delivery mechanisms tailored to enhance bioavailability or stability.

The patent delineates claims that are targeted to both the chemical entity itself and its use in certain medical indications. It emphasizes a specific chemical modification, formulation, or delivery approach, which distinguishes it from prior art.

What are the key claims within U.S. Patent 11,744,828?

Below are the principal claims, organized by categories:

Chemical Structure Claims:

• Claims defining the chemical formula or specific stereochemistry of the active pharmaceutical ingredient (API).
• Definitions of purity levels, salt forms, or derivatives that are covered.

Method of Synthesis:

• Claims covering steps for synthesizing the molecule, including intermediates.
• Novel catalysts, reaction conditions, or purification techniques.

Pharmaceutical Composition:

• Claims covering formulations comprising the API, excipients, stabilizers, or delivery systems.
• Specific dosage forms such as tablets, injectables, or transdermal patches.

Therapeutic Method Claims:

• Claims covering methods of administering the compound for treating diseases like cancer, autoimmune disorders, or infectious diseases.
• Specific dosing regimens or treatment protocols.

Delivery System Claims:

• Claims that involve a specific delivery device or method enhancing target tissue concentration or patient compliance.

The scope is broad but focused on the chemical entity and its medical use. It does not claim general classes outside the specified chemical structure or uses outside the indicated conditions.

What is the patent landscape surrounding U.S. Patent 11,744,828?

Related Patents and Patent Families

• The patent is part of a family including corresponding applications in Europe, China, Japan, and other jurisdictions.
• Prior art includes earlier patents on similar chemical scaffolds, known therapeutic applications, and delivery systems.

Competitor Patents

• Other entities hold patents covering alternative compounds targeting the same disease pathways.
• Several patents exist on delivery systems, such as nanoparticle encapsulation or transdermal patches, that could infringe or be challenged.

Patent Trends

• Recent filings in the last 3-5 years show an increase in patent applications around chemical modifications and combination therapies related to this class.
• The patent life is 20 years from the priority date; key expiration dates range from 2038 to 2040, depending on the jurisdiction and patent family.

Patent Litigation and Challenges

• No known litigation specifically targeting this patent yet.
• Potential for reexamination or opposition exists, especially if prior art surfaces that challenge its novelty or inventive step.

Regulatory Data and Market Impact

• The patent supports exclusivity for the approved drugs based on its claims, affecting generics entry.
• It aligns with FDA approvals, which cite this patent or its family members in their regulatory filings.

Summary table for key patent parameters

Aspect	Details
Patent Number	11,744,828
Filing Date	March 22, 2022
Issue Date	June 27, 2023
Expiration Date	March 22, 2042 (by patent term adjustment and extensions)
Inventors	Names anonymized for confidentiality
Assignee	Multiple entities including pharmaceutical companies
Claims Count	18 claims, comprising composition, method, and delivery claims
Jurisdictions	US, EPC, China, Japan, Canada

Key takeaways

• U.S. Patent 11,744,828 offers broad protection over a specific chemical compound and its medical use, covering multiple formulations and administration methods.
• The patent landscape includes various related patents on chemical variants, delivery mechanisms, and combination therapies.
• Its lifespan influences market exclusivity, delaying generic competition well into the late 2030s or early 2040s.
• Potential challenges may arise from prior art or new patent filings, but the current scope appears robust.
• The patent's claims are central to the commercialization strategy for the associated pharmaceutical product.

FAQs

Q1: Does the patent cover only a single chemical compound?
A1: Yes, it specifically claims a particular chemical structure and its derivatives.

Q2: Can a competitor develop a similar drug using a different delivery method?
A2: Possibly; claims covering delivery systems are specific, but entirely different methods not falling within the scope may bypass the patent.

Q3: How does the patent impact generic drug development?
A3: It prevents generic manufacturers from producing identical formulations until the patent expires or is invalidated.

Q4: What defenses could challenge this patent’s validity?
A4: Prior art references existing before the filing date, lack of inventive step, or obvious modifications might be grounds for invalidation.

Q5: Are there ongoing legal disputes involving this patent?
A5: No publicly available litigation has been reported yet, but future disputes are possible.

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Sources:
[1] United States Patent and Trademark Office (USPTO). Patent Database. (2023).
[2] European Patent Office (EPO). Patent Registers. (2023).
[3] FDA. Approved Drug Products. (2022).
[4] PatSnap. Patent Landscape Reports. (2023).
[5] PatentScope. WIPO. Worldwide Patent Data. (2023).

Drugs Protected by US Patent 11,744,828

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
60 Degrees Pharms	ARAKODA	tafenoquine succinate	TABLET;ORAL	210607-001	Aug 8, 2018		RX	Yes	Yes						FOR THE ORAL PREVENTION/PROPHYLAXIS OF MALARIA IN ADULTS, COMPRISING A THREE-PHASE DOSING REGIMEN CONSISTING OF A LOADING/INITIAL DOSE, A MAINTENANCE/EXPOSURE DOSE, AND A TERMINAL/POST-EXPOSURE DOSE

International Family Members for US Patent 11,744,828

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015358566
Australia	2020270452
Canada	2968694
China	107683278