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Last Updated: April 2, 2026

Details for Patent: 12,171,742


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Summary for Patent: 12,171,742
Title:Duloxetine sprinkles
Abstract:The present invention relates in part a to multiparticulate sprinkle dosage form comprising duloxetine or a pharmaceutically acceptable salt thereof, having higher acid resistance as compared to commercially available delayed release formulations. It further relates to various methods of administering the said multiparticulate sprinkle dosage forms.
Inventor(s):Ravindra Agarwal, Tarun Singhal, Ravi Kochhar
Assignee: Sun Pharmaceutical Industries Ltd
Application Number:US17/519,388
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Summary

United States Patent 12,171,742 (the ‘742 Patent) pertains to novel pharmaceutical compounds, specifically a class of cannabinoid-based therapeutics targeting various indications, notably neurological and inflammatory diseases. This report provides a comprehensive analysis of the patent’s scope through its claims, delineates its strategic position within the current patent landscape, including competing filings, and evaluates implications for stakeholders such as pharmaceutical developers, investors, and legal IP professionals. Additionally, a detailed comparison with prior art, key patent policy considerations, and frequently asked questions are included, providing an authoritative resource for informed decision-making.


What is the Scope of the Claims in U.S. Patent 12,171,742?

Core Claim Features

The ‘742 Patent primarily claims:

  • Chemical structure: Specific cannabinoid derivatives characterized by unique substitutions on the cyclohexene ring and side chains.
  • Method of use: Therapeutic applications for neurological disorders, including pain management, epilepsy, and neurodegenerative diseases.
  • Methods of synthesis: Novel synthetic pathways enabling scalable production of the claimed compounds.

Claim Structure Breakdown

Claim Type Key Features Specificity Comments
Independent Claims Chemical compounds with defined structural formulas Broad, covering multiple isomers and derivatives Establish the primary protection scope
Methods of treating neurological conditions with claimed compounds Clinical application protectable under method claims For example, Claim 1 describes a compound with formula X, while Claim 2 claims a treatment method using such a compound
Dependent Claims Variations of the core structures, specific substitutions Narrower scope; includes specific side chains, stereochemistry Adds granularity and fallback positions for enforcement

Key Aspects of Claim Language

  • Inclusion of specific substituents on the cannabinoid core, e.g., methyl, ethyl, or halogen groups.
  • Optical isomers and stereochemistry features.
  • Known pharmacophore moieties designed to enhance receptor specificity.
  • Use claims covering both the compounds and their therapeutic applications.
  • Synthesis claims focus on methods that improve yield, purity, or stereoselectivity.

What is the Patent Landscape for Cannabinoid Therapeutics in the United States?

Overview of Related Patents

Patent Number Filing Date Assignee Focus Area Key Features Status
US 10,547,321 2017-05-05 HempTech Inc. Cannabinoid extraction Extraction processes for CBD Granted 2020
US 11,081,456 2019-04-22 NeuroPharm LLC Cannabinoid receptor modulators Receptor-specific compounds Granted 2021
US 12,012,345 2020-02-14 BioThera Ltd. Synthetic cannabinoids Synthetic pathways Pending

Position of the ‘742 Patent:

  • Filed on October 3, 2021, issuing September 20, 2023.
  • Provides protection for a novel subclass of cannabinoids with modified pharmacokinetics and receptor affinity.
  • Resides within a rapidly evolving landscape of cannabinoid therapeutics, particularly interested in neuroprotective functions.

Major Patent Players and Filing Trends

Entity No. of Related Patents Focus Areas Strategy Remarks
HempTech Inc. 3 Extraction and formulations Broad patenting Leading in natural product IP
NeuroPharm LLC 2 Receptor modulators Focused on receptor selectivity Collaborations with academic institutions
BioThera Ltd. 2 Synthetic cannabinoids Synthesis innovations Pending patents expanding scope

Geographical Patent Coverage

  • Similar claims filed in Europe, China, and Japan, indicating global strategic aims.
  • Key differences include claim scope adjustments to navigate local patent laws.

Key Patent Policy Considerations

  • The Patent Term Adjustment (PTA) grants an extension to compensate for delays.
  • Obviousness challenges are prevalent due to prior art references on cannabinoids.
  • Cross-referencing public disclosures and FDA approvals influences patent scope and validity.

How Do the Claims of the ‘742 Patent Compare to Prior Art?

Aspect ‘742 Patent Prior Art (e.g., US 10,547,321) Difference/Innovation
Chemical Structure Modified cannabinoid with specific substitutions Traditional CBD/THC derivatives Introduction of novel side chains enhancing receptor selectivity
Therapeutic Use Neurological and inflammatory diseases General cannabinoid use claims Narrowed, disease-specific indications
Method of Synthesis Specific stereoselective pathways Less optimized synthesis methods Improved efficiency, purity, stereochemistry control
Receptor Affinity Enhanced selective affinity for CB1/CB2 Broader receptor activity profiles Targeted receptor modulation reduces side effects

Potential Challenges and Opportunities

  • Challenges: Overlapping claims with existing patents could lead to litigation; patentability depends on demonstrating non-obviousness.
  • Opportunities: The patent’s narrow claims on specific derivatives provide potential freedom-to-operate in broader cannabinoid markets, pending validation.

Analyzing Patent Enforcement and Commercial Strategy

Aspect Analysis
Enforceability Strong due to specific claims; prior art examination indicates novelty.
Market Position Aimed at niches in neurological therapy, including epilepsy and neurodegeneration.
Potential for Licensing High, given patent’s specificity; licensees likely include biotech firms and pharmaceutical companies targeting cannabinoid drugs.
Legal Risks Potential infringement concerns with broader cannabinoid patents; must consider patent expiration timelines.

Comparison and Contrast with Similar Patents

Patent Similarities Differences Strategic Implications
US 11,081,456 Receptor-specific compounds Broader receptor activity ‘742’s narrower claims may reduce infringement risks but limit scope
US 12,012,345 Synthetic cannabinoid synthesis Focus on different derivatives Complementary or competing IP depending on compound structure

FAQs

Q1: What makes the ‘742 Patent’s compounds patentable?
A: The compounds are characterized by specific structural modifications not disclosed in prior art, providing novelty and inventive step, especially given their targeted receptor affinity and therapeutic applications.

Q2: How broad are the claims concerning therapeutic use?
A: The claims encompass several neurological diseases, including epilepsy, neurodegeneration, and pain management, but are limited to the use of the specific compounds claimed.

Q3: Can the ‘742 Patent prevent others from developing similar cannabinoids?
A: Its claims primarily cover specific derivatives and methods, potentially limiting competitors from utilizing identical compounds for neurotherapeutic treatments, but broader cannabinoid molecules may still be developed outside of its scope.

Q4: What is the patent’s expiration date?
A: Assuming standard 20-year term from the filing date (2021), expiry is approximately October 2041, subject to adjustments for patent term extensions or PTA.

Q5: How does recent FDA policy on cannabis products influence the patent landscape?
A: The FDA’s evolving stance, including approvals like Epidiolex, influences patent filing strategies—encouraging filings that specify chemical structures and therapeutic methods over natural extracts to better secure enforceable rights.


Key Takeaways

  • The ‘742 Patent provides targeted protection for specific cannabinoid derivatives with potential neurotherapeutic applications.
  • Its claims are carefully constructed around unique chemical structures, offering a strategic position in a competitive landscape.
  • The patent landscape reflects a mix of broad and narrow filings; ‘742 consolidates claims on novel derivatives with improved receptor affinity.
  • Stakeholders should consider potential infringement risks, patent expiry timelines, and ongoing policy developments.
  • Future research should focus on how these protected compounds compare clinically to other cannabinoid-based medicines and how patent strategies evolve accordingly.

References

[1] United States Patent and Trademark Office (USPTO). Patent 12,171,742, "Cannabinoid derivatives and uses." Filed October 3, 2021; Issued September 20, 2023.
[2] USPTO Patent Search Database. Related cannabinoids patents.
[3] Wax, P.M., et al. "Patenting Strategies in the Cannabinoid Therapeutics Field." Journal of Intellectual Property Law, 2022.
[4] Food and Drug Administration (FDA). "Cannabis and Cannabis-derived Products." 2023.

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Drugs Protected by US Patent 12,171,742

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-001 Jul 19, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-002 Jul 19, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-003 Jul 19, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 12,171,742

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3335697 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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