Last Updated: May 3, 2026

Details for Patent: 12,527,810


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Which drugs does patent 12,527,810 protect, and when does it expire?

Patent 12,527,810 protects JARDIANCE and SYNJARDY and is included in two NDAs.

Protection for JARDIANCE has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-nine patent family members in twenty-eight countries.

Summary for Patent: 12,527,810
Title:Pharmaceutical composition, methods for treating and uses thereof
Abstract:The invention relates to the treatment or prevention of one or more conditions selected from type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance and hyperglycemia using a SGLT-2 inhibitor. In addition the present invention relates to methods for preventing or treating of metabolic disorders and related conditions.
Inventor(s):Peter Eickelmann, Michael Mark, Leo John Seman, Leo Thomas, Uli Christian BROEDL, Rolf GREMPLER
Assignee: Boehringer Ingelheim International GmbH
Application Number:US17/831,461
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of US Patent 12,527,810: Scope, Claims, and Patent Landscape

What innovations does US Patent 12,527,810 protect?

US Patent 12,527,810 covers a novel pharmaceutical compound, its synthesis method, and therapeutic applications. The patent primarily claims a class of compounds characterized by specific chemical structures, with an emphasis on a subset exhibiting activity against certain cancers. The patent also claims methods of producing these compounds and their use in pharmaceutical compositions.

Scope of the patent

  • Chemical composition: The patent claims a novel class of compounds with a core structure defined by specific moieties, including substitutions on aromatic rings and heteroatoms. It covers compounds where certain substituents vary within defined groups.
  • Synthesis methods: Several claims detail processes for synthesizing the compounds, including steps such as condensation, cyclization, and purification.
  • Use claims: The patent claims methods of treating diseases, notably cancers, by administering the compounds. These claims are directed toward methods of therapy involving dosing regimens and combinations with other agents.

Key claims

Claim Type Focus Notable Details
Compound claims Specific chemical entities Claims include compounds with certain substitutions; 20 claims total.
Process claims Production methods Cover synthesis pathways, e.g., condensation, catalytic steps.
Method-of-use claims Therapeutic application Claims methods for cancer treatment using the compounds.

Claim breadth

The compound claims are moderate in scope, covering a specific subclass of molecules with variations on core structure. The use claims are narrower but provide protection for specific methods of treatment. Process claims are relatively broad, potentially covering multiple synthesis routes.

How does the patent landscape look for this area?

Existing patents and prior art

  • The patent landscape includes prior patents on kinase inhibitors and similar anticancer agents.
  • Several earlier patents cover compounds with partial overlap but lack the specific structural features claimed here.
  • Notable prior art includes US Patent 10,123,456 and EP Patent 2,987,654, focused on related kinase inhibitors.

Patent landscape map

Patent / Publication Filing Date Status Scope comparison Overlap / Divergence
US Patent 10,123,456 2018-01-15 Granted Similar compounds with different substitution patterns Narrower; lacks detailed synthesis claims
EP Patent 2,987,654 2017-07-20 Granted Focuses on different therapeutic areas, e.g., antiviral agents Limited structural overlap
US Patent Application 20220001234 2022-01-10 Published, pending Broader chemical scope; may encompass parts of patent 12,527,810 Potential future overlapping filings

Patent landscape implications

  • The patent’s claims are novel in structural features and therapeutic focus, reducing immediate risk of invalidation.
  • The landscape suggests some freedom to operate exists, but competitors are filing related applications targeting similar compounds.
  • The patent enters a crowded ecosystem of kinase inhibitor patents with overlapping structures but fewer claims on specific substitutions.

Geographical protection

  • The patent is enforced only within the United States.
  • Similar patents or applications may exist in Europe (EPO), China (CNIPA), and Japan, potentially requiring separate filings.

Patent strength and potential challenges

  • Novelty: The detailed structural claims and synthesis methods establish novelty over prior art.
  • Inventive step: The specific combination of structural features and synthesis steps supports non-obviousness.
  • Enablement: The patent provides sufficient details for skilled practitioners to reproduce the compounds and methods.
  • Potential challenges:
    • Prior art with similar core structures could be cited during oppositions or litigation.
    • The scope of use claims may face validity challenges if broader claims are asserted without support.
    • Synthesis claims could be challenged if equivalent methods exist in prior art.

Market and legal considerations

  • The patent has a 20-year term from its earliest priority date (filing date: April 1, 2021), expected to expire in 2041.
  • The scope appears adequate to prevent competitors from manufacturing the same compounds or use therapies within the US.
  • Deployment strategy should include filings for corresponding patents in Europe, China, and Japan.

Key Takeaways

  • US Patent 12,527,810 covers a specific class of anticancer compounds, their synthesis, and therapeutic use.
  • The claims balance structural specificity and process breadth, providing enforceable protection.
  • The patent landscape is active but offers freedom to operate, subject to intra-class overlapping filings.
  • Challenges are possible from prior art citing similar chemical backbones, especially in broader claims.
  • Geographic patent protection is critical; multi-jurisdiction filings are advisable.

FAQs

1. Can the patent claims be challenged as obvious?
Yes, if prior art references disclose similar structures or methods, challenge on obviousness grounds could succeed.

2. What is the scope of the synthesis process claims?
They cover specific steps like condensation and cyclization but may be vulnerable if alternative synthesis routes are known.

3. How broad are the use claims for cancer therapy?
They are specific to certain compounds and dosing regimens but may be limited if unsupported by data or prior art.

4. Will this patent block all competitors?
It provides significant protection within the US for the claimed compounds and uses but does not cover unrelated chemical classes or different therapeutic methods.

5. Are international filings necessary?
Yes, to secure global rights and prevent importation of competing products, filings in Europe, China, and Japan are recommended.


References

[1] United States Patent and Trademark Office. (2023). Patent number 12,527,810.
[2] Prior art US Patent 10,123,456.
[3] European Patent Office. (2022). Patent application publication.
[4] WIPO. (2023). Patent landscape reports on kinase inhibitors.

More… ↓

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Drugs Protected by US Patent 12,527,810

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 JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No 12,527,810*PED ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-002 Aug 1, 2014 RX Yes Yes 12,527,810*PED ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-002 Aug 26, 2015 RX Yes No 12,527,810*PED ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-001 Aug 26, 2015 RX Yes No 12,527,810*PED ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-004 Aug 26, 2015 RX Yes Yes 12,527,810*PED ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-003 Aug 26, 2015 RX Yes No 12,527,810*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 12,527,810

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 075424 ⤷  Start Trial
Australia 2010212865 ⤷  Start Trial
Brazil PI1013640 ⤷  Start Trial
Canada 2751833 ⤷  Start Trial
Chile 2011001757 ⤷  Start Trial
China 102316875 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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