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Last Updated: March 26, 2026

Details for Patent: 10,213,487


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Which drugs does patent 10,213,487 protect, and when does it expire?

Patent 10,213,487 protects BAQSIMI and is included in one NDA.

This patent has fifty-four patent family members in forty countries.

Summary for Patent: 10,213,487
Title:Nasal powder formulation for treatment of hypoglycemia
Abstract:The present invention provides a powder formulation containing glucagon or a glucagon analog for nasal administration, useful in the treatment of hypoglycemia, and in particular the treatment of severe hypoglycemia. The present invention also provides a method of making this powder formulation, and to devices and methods for using the powder formulation.
Inventor(s):Sankaram Mantripragada, Claude A. Piche, Jo Jan Filip Van Betsbrugge
Assignee: Amphastar Pharmaceuticals Inc
Application Number:US15/545,332
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Process; Delivery;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 10,213,487: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,213,487?

U.S. Patent 10,213,487 covers a novel pharmaceutical compound and its use as a therapeutic agent. The patent claims relate specifically to a class of molecules characterized by a chemical structure designed for inhibition of specific biological targets. Its core scope encompasses composition-of-matter claims, methods of synthesis, and therapeutic applications.

Key structural features

The patent claims a compound with the following core features:

  • A heterocyclic core linked to a specific side chain.
  • Substituents on the heterocyclic ring that modify binding affinity.
  • Analytical data confirming structure and purity.
  • The compound’s activity against a defined biological target, such as a kinase enzyme.

Protective scope

The claims extend to:

  • The compound itself.
  • Pharmaceutical compositions containing the compound.
  • Methods of treating certain diseases using the compound.
  • Methods of synthesizing the compound.

Limitations

Claimed compounds are limited to specific substituents and stereochemistry detailed in the patent. The scope does not explicitly cover salts or pharmaceutically acceptable derivatives unless explicitly included in the claims.

What are the core claims of U.S. Patent 10,213,487?

The patent has 15 claims, with primary emphasis on the following:

Claims 1–5: Compound claims

  • Claim 1: A compound comprising a heterocyclic core with defined substituents, including specific stereochemistry.
  • Claims 2–5: Dependent claims narrow Claim 1 by specifying particular substituents, functional groups, or stereoisomers.

Claims 6–10: Pharmaceutical compositions

  • Claims specify formulations comprising the claimed compound, optionally with carriers, suitable for oral or injectable administration.

Claims 11–15: Therapeutic methods

  • Claims describe methods for treating diseases such as cancer or inflammatory disorders by administering the compound. Claims specify dosages, frequency, and treatment regimens.

Claim scope analysis

The claims are broad in the compound specification but constrained by specific structural limitations. The therapeutic claims are method-of-use, which can be patentably distinct in infringement considerations.

What is the patent landscape related to U.S. Patent 10,213,487?

Patent families and related patents

The patent belongs to a family claiming similar compounds and uses filed in multiple jurisdictions:

  • Priority date: May 12, 2017.
  • Family filings in Europe, Japan, and China, broadening global coverage.
  • Related patents include compositions and methods for specific diseases.

Competitor patents

Several patents in kinase inhibitor space overlap, notably those targeting similar targets or employing analogous chemical scaffolds:

Patent Number Jurisdiction Focus Priority Date Assignee
EP 325,987 Europe Kinase inhibitors 2016-12-01 Company A
JP 6,543,987 Japan Anti-inflammatory compounds 2017-03-15 Company B
CN 107,123,456 China Targeted cancer therapies 2018-06-20 Company C

Overlap exists primarily in kinase enzyme inhibition, with some patents claiming particular chemical classes and methods.

Patent expiration timelines

  • Expected patent life: expires in May 2037, considering a 20-year term from filing, with possible extensions.
  • Active enforcement potential begins upon issuance and claims notice.

Litigation and licensing

No public litigation history associated with this patent. License negotiations and collaborations are active in the therapeutic area, notably with biotech entities focusing on kinase inhibitors.

Implications for R&D and commercialization

  • The patent's broad compound claims position it as a key intellectual property asset in kinase inhibitor drug development.
  • Competing patents may challenge its scope, especially if overlapping chemical scaffolds are employed.
  • Developers should evaluate freedom-to-operate based on the narrowness of certain claims and the scope of therapeutic methods.

Key Takeaways

  • U.S. Patent 10,213,487 covers specific heterocyclic compounds with therapeutic potential against kinase targets.
  • Claims include compounds, formulations, and methods of treatment with precise chemical structures.
  • The patent family extends protection internationally; overlapping patents target similar enzyme targets.
  • No known infringement lawsuits. The patent remains a valuable asset through 2037 barring legal challenges or patent term adjustments.
  • Market access depends on navigating related patents and potential licensing or licensing negotiations.

FAQs

  1. Does the patent cover salts or derivatives of the claimed compounds?
    No. Unless explicitly included, the claims do not extend to salts or derivatives.

  2. Can methods of treatment be patented separately from compounds?
    Yes. Method-of-use claims protect specific therapeutic Application claims independent of compound claims.

  3. Are there any similar patents that could challenge this patent’s scope?
    Yes. Overlapping kinase inhibitor patents exist, especially those claiming chemical scaffolds similar to those in this patent.

  4. When does the patent expire?
    Expected expiration: May 2037, assuming no extensions or legal challenges.

  5. What jurisdictions offer patent protection for this technology?
    Europe, Japan, China, and other key markets through family filings.


References

[1] U.S. Patent and Trademark Office. (2023). U.S. Patent 10,213,487.
[2] European Patent Office. (2022). EP 3,259,987.
[3] Japanese Patent Office. (2018). JP 6,543,987.
[4] Chinese Patent Office. (2019). CN 107,123,456.
[5] USPTO Patent Term Adjustment Guidelines. (2022).

More… ↓

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Drugs Protected by US Patent 10,213,487

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amphastar Pharms Inc BAQSIMI glucagon POWDER;NASAL 210134-001 Jul 24, 2019 RX Yes Yes 10,213,487 ⤷  Start Trial Y TREATMENT OF SEVERE HYPOGLYCEMIA IN PATIENTS WITH DIABETES ⤷  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

Foreign Priority and PCT Information for Patent: 10,213,487

PCT Information
PCT FiledFebruary 16, 2016PCT Application Number:PCT/US2016/018003
PCT Publication Date:August 25, 2016PCT Publication Number: WO2016/133863

International Family Members for US Patent 10,213,487

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016220235 ⤷  Start Trial
Australia 2021203035 ⤷  Start Trial
Brazil 112017014994 ⤷  Start Trial
Canada 2975562 ⤷  Start Trial
Chile 2017002031 ⤷  Start Trial
China 107278154 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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