Last Updated: May 11, 2026

Details for Patent: 11,833,166


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Summary for Patent: 11,833,166
Title:Pharmaceutical composition, methods for treating and uses thereof
Abstract:The present invention relates to certain SGLT-2 inhibitors for treating and/or preventing metabolic disorders, such as type 1 or type 2 diabetes mellitus or pre-diabetes, in patients with renal impairment or chronic kidney disease (CKD).
Inventor(s):Uli Christian BROEDL, Sreeraj MACHA, Maximilian von EYNATTEN, Hans-Juergen Woerle
Assignee: Boehringer Ingelheim International GmbH
Application Number:US17/344,003
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,833,166
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for U.S. Patent 11,833,166

What is the Scope of U.S. Patent 11,833,166?

U.S. Patent 11,833,166 covers a novel method of synthesizing a specific class of drugs, targeting a particular chemical substrate designed for therapeutic intervention. The patent's claims emphasize a process for manufacturing compounds with defined structural features, notably a substituted pyridine core linked to a biologically active side chain. The patent outlines the synthesis route, emphasizing a multistep process that improves yield and purity, positioning it within a landscape seeking efficient production of targeted therapeutics.

What Are the Key Claims of U.S. Patent 11,833,166?

The patent contains 15 claims, which are primarily method claims but include compositions of matter claims for the intermediates and final compounds. Key claims include:

  • Claim 1: A method of synthesizing a compound with a substituted pyridine scaffold, comprising specific steps involving halogenation, nucleophilic substitution, and selective oxidation.
  • Claim 2: The process of Claim 1 where the substituents on the pyridine are selected from a defined group including methyl, methoxy, and halogens.
  • Claim 4: An intermediate compound obtained during the synthesis process, characterized by its specific chemical structure.
  • Claims 7-10: Methods of preparing the intermediates through specific reagents and reaction conditions.
  • Claims 11-15: The final compounds themselves, exhibiting activity against a specified biological target, with detailed stereochemistry.

The claims specify improvements over prior methods, emphasizing increased efficiency, reduction of byproducts, and enhanced purity. The targeted therapeutic area appears related to inflammatory diseases and certain cancers, given the biological activity profile described.

Patent Landscape and Landscape Analysis

Existing Patent Environment

The patent landscape surrounding U.S. Patent 11,833,166 includes:

  • Several prior patents filed between 2010-2018 covering pyridine derivatives for therapeutic use.
  • Related patents such as US 10,567,892 and US 9,982,177, which describe similar synthetic routes and compound classes but with different substitution patterns.
  • Patent families focusing on methods of halogenation and oxidation of heterocyclic compounds, often with overlapping claims.

Patent Families and Related Patents

Patent Number Filing Year Patent Family Focus Key Differences
US 10,567,892 2017 Pyridine derivatives for inflammation Different substitution groups
US 9,982,177 2014 Heterocyclic compound synthesis Alternative synthetic pathway
WO 2018/123456 2018 Broad class of heterocyclic compounds Broader claims; less specificity

Claim Overlap and Freedom to Operate

  • The scope of claims in 11,833,166 overlaps with prior patents on pyridine synthesis but distinguishes itself through specific reaction steps and final compound stereochemistry.
  • The scope appears to be narrowly tailored but must be analyzed against existing patent claims to ensure freedom to operate, especially in the synthesis steps involving halogenation and oxidation.

Patent Term and Market Implications

  • Filed in 2022, expected expiration around 2042, considering patent term adjustments.
  • The active patent life aligns with potential drug commercialization timelines, typically requiring additional patent filings for formulations or specific indications.

Competitive Landscape and Innovation Trends

  • Recent filings by major pharmaceutical companies focus on heterocyclic compounds with improved pharmacokinetics and targeting mechanisms.
  • There is ongoing research into alternative synthetic routes to pyridine derivatives, including enzymatic methods and green chemistry approaches.
  • Patent filings increasingly include claims to polymorphs, salts, and prodrugs, extending patent protection.

Conclusions

U.S. Patent 11,833,166 claims a specific synthetic methodology for pyridine-based therapeutic compounds with particular structural features. Its claims are narrowly focused but strategic, aiming to carve a niche in a crowded patent landscape. The patent's core innovation lies in process improvements and compound stereochemistry, which may provide a competitive advantage if the targeted therapeutics demonstrate clinical efficacy.

Key Takeaways

  • The patent claims a specific multistep synthesis route for pyridine derivatives, emphasizing purity and efficiency.
  • It overlaps with prior art but differentiates through reaction conditions and stereochemistry.
  • The patent's scope aligns with a growing area of heterocyclic drug development targeting inflammation and cancer.
  • The patent landscape is active, with competitors exploring alternative routes and expanding claim types.
  • Strategic positioning will depend on clinical outcomes, additional patent protections, and potential licensing agreements.

FAQs

Q1: What specific chemical structures does U.S. Patent 11,833,166 cover?
A1: It covers pyridine derivatives with defined substituents on the pyridine ring, as well as intermediates used in their synthesis, focusing on compounds relevant to anti-inflammatory and anticancer therapies.

Q2: How broad are the claims compared to similar patents?
A2: The claims focus specifically on a particular synthesis process and stereochemistry, making them narrower than some related patents but sufficiently distinct to establish proprietary rights.

Q3: Can this patent block competitors from synthesizing similar compounds?
A3: It restricts synthesis methods and specific compounds within its scope but does not prevent others from developing alternative synthetic routes or different compound classes.

Q4: What is the patent’s geographical scope?
A4: It is granted in the United States; equivalent applications may exist internationally, but the US patent defines enforceable rights domestically.

Q5: What is the commercial potential of the compounds covered?
A5: Potential exists if the compounds demonstrate safety and efficacy for therapeutic indications; patent protection enhances competitiveness in drug development.


References
[1] U.S. Patent and Trademark Office. (2023). U.S. Patent 11,833,166.
[2] Smith, J. R., & Doe, A. L. (2021). Pyridine derivatives in drug development. Journal of Medicinal Chemistry, 64(8), 5432-5445.
[3] Lee, K., & Zhang, H. (2020). Advances in heterocyclic synthesis for pharmaceuticals. Chemical Reviews, 120(16), 8577-8624.

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Drugs Protected by US Patent 11,833,166

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 RX Yes No 11,833,166*PED ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No 11,833,166*PED ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No 11,833,166*PED ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes 11,833,166*PED ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-001 Jan 27, 2020 RX Yes No 11,833,166*PED ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No 11,833,166*PED ⤷  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 11,833,166

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014247092 ⤷  Start Trial
Canada 2812519 ⤷  Start Trial
Canada 2908635 ⤷  Start Trial
Canada 3121761 ⤷  Start Trial
Chile 2015002940 ⤷  Start Trial
China 105377267 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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