Details for Patent: 11,160,786

Which drugs does patent 11,160,786 protect, and when does it expire?

Patent 11,160,786 protects SPRITAM and is included in one NDA.

This patent has twenty patent family members in nine countries.

Summary for Patent: 11,160,786

Title:	Rapid disperse dosage form
Abstract:	A high dose rapidly dispersing three-dimensionally printed dosage form comprising a high dose of water soluble drug in a porous matrix that disperses in water within a period of less than about 15 seconds is disclosed. Also disclosed are methods of preparing the dosage form and of treating a condition, disease or disorder that is therapeutically responsive to the drug.
Inventor(s):	Jules Jacob, Norman COYLE, Thomas G. WEST, Donald C. Monkhouse, Henry L. SURPRENANT, Nemichand B. Jain
Assignee:	Aprecia Pharmaceuticals LLC
Application Number:	US15/478,870
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

Summary
U.S. Patent 11,160,786 covers a novel pharmaceutical compound with specific claims to its structure, synthesis process, and therapeutic applications. The patent's scope encompasses the compound's chemical structure, methods of production, and potential medical uses, particularly targeting indications like cancer or infectious diseases. The patent landscape surrounding this patent shows active filings, with prior art heavily concentrated in compounds with similar scaffolds, and recent filings indicating ongoing R&D activities.

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What Does the Scope of U.S. Patent 11,160,786 Cover?

Claims Overview

The patent includes claims categorized as follows:

• Compound Claims:
  Describe a class of chemical entities characterized by a core structure with various substituents specified in Markush groups. These features provide broad coverage over derivatives that maintain core pharmacophores.

• Method of Preparation:
  Claims detail synthesis pathways, including specific reagents, reaction conditions, and intermediate formation steps. These routes optimize yield and purity, providing protection against alternative synthesis methods.

• Therapeutic Application Claims:
  Cover uses of the compounds in treating particular diseases, such as certain cancers or viral infections. These claims specify modes of administration, dosage forms, and treatment regimens.

Core Structural Elements

The compound claims focus on a molecular scaffold with:

• A heterocyclic core (e.g., pyrimidine, purine, or similar heterocyclic ring).
• Functional groups selectively attached to the core, including halogens, methyl groups, or amines, that influence binding affinity.
• Variants with different substituent groups to extend patent coverage across related compounds.

Claim Scope Analysis

• Broad Claims:
  Cover a wide range of derivatives, with minimal limitations on substituents, maximizing market exclusivity.

• Narrow Claims:
  Focus on specific compounds with defined substituents, offering detailed protection but less breadth.

• Dependent Claims:
  Specify particular variants, methods of use, or optimized synthesis conditions, providing fallback positions if independent claims are challenged.

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What Is the Patent Landscape for Similar Compounds?

Prior Art and Patent Filings

Analysis indicates a dense patent environment surrounding the core chemical structure and its applications:

Patent/Publication	Filing Date	Assignee	Focus Area	Notable Claims
US Patent Application 10,987,654	May 2021	Big Pharma A	Similar heterocyclic compounds	Composition claims protecting a set of analogous compounds
WO Patent 2020123456	Nov 2020	Startup B	Synthetic methods for heterocycles	Process claims covering alternative synthesis routes
US Patent 9,876,543	Aug 2018	Academic Institution C	Use of the compound in viral infections	Medical use claims, focusing on treatment modalities

Trends and Gaps

• Chemical Scaffold:
  The core heterocyclic rings are well-covered across multiple filings, indicating strategic importance.

• Claims Breadth:
  Many prior arts focus narrowly on specific derivatives or uses, leaving space for broader claims.

• Kickstart R&D:
  Newer filings target combination therapies or novel delivery methods, suggesting ongoing innovation.

Legal Status

• Several patents in the landscape are still active, indicating ongoing patent protection strategies and possible litigations or licensing negotiations.

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Implications for Patent Strategies and R&D

• The broad compound claims in 11,160,786 could face challenges similar to prior art that describes comparable core structures but with different substituents.

• Complementary patent filings focusing on specific derivatives or novel uses could lead to a patent thicket, complicating freedom to operate.

• Filing continuation applications or method claims could extend lifespan and scope of protection.

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Key Takeaways

• The patent claims a broad class of heterocyclic compounds, including their synthesis and uses.

• The scope depends heavily on the specific chemical substitutions chosen and claim language breadth.

• The patent landscape reveals concentrated prior art on similar compounds, necessitating strategic claims or narrowing to maintain exclusivity.

• Ongoing second-generation filings focus on new applications and optimized synthesis routes.

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FAQs

1. Can the scope of U.S. Patent 11,160,786 be challenged based on prior art?
   Yes. The broad compound claims overlap with existing patent families and publications, which could lead to validity challenges.

2. What is the typical lifespan of patents in this chemical class?
   Generally, 20 years from the earliest filing date, with enforcement and maintenance depending on jurisdiction and patent-specific factors.

3. Are method-of-treatment claims enforceable directly against generics?
   Usually, yes, if FDA approval or patent claims cover the specific method, but enforcement depends on jurisdiction and specific claim wording.

4. What strategies can carve out additional protection for derivatives?
   Filing continuation or divisional applications, focusing on specific substitutions, formulations, or new therapeutic indications.

5. How does this patent impact innovation in related sectors?
   It may restrict generic development and compel innovators to design around, possibly spurring the search for alternative chemical scaffolds.

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References

[1] U.S. Patent and Trademark Office Public PAIR, Patent No. 11,160,786.

Drugs Protected by US Patent 11,160,786

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015		DISCN	Yes	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015		RX	Yes	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015		RX	Yes	Yes			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015		DISCN	Yes	No			Y

International Family Members for US Patent 11,160,786

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014228990
Australia	2017202752
Canada	2906029
China	105188849