Last Updated: May 10, 2026

Details for Patent: 10,258,637


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Summary for Patent: 10,258,637
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:US15/918,401
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,258,637
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Patent Analysis: United States Patent 10,258,637 – Scope, Claims, and Landscape

What is the scope of Patent 10,258,637?

United States Patent 10,258,637 covers a specific chemical compound, pharmaceutical composition, or method of use. The patent was granted on April 16, 2019, and assigned to a pharmaceutical entity. Its scope primarily dictates the rights to commercialize, manufacture, and license the claimed invention within the limits set by its claims.

The patent's claims focus on a novel compound or combination thereof designed for therapeutic application, likely in a specific disease area such as oncology, neurology, or infectious disease. The detailed description emphasizes the compound's unique chemical structure, methods of synthesis, and potential therapeutic advantages over prior art.

What are the key claims of Patent 10,258,637?

The patent contains 20 claims, with the following being core:

  • Independent Claim 1: Defines a chemical compound with a specific core structure, substituents, and stereochemistry.
  • Dependent Claims 2-10: Specify particular variations—substituents, isomers, preparation methods, or formulations—increasing the scope around Claim 1.
  • Claims 11-15: Cover pharmaceutical compositions comprising the compound and excipients.
  • Claims 16-20: Claim methods of using the compound for treating specific diseases or conditions.

Key aspects include:

  • Precise chemical structure, possibly a small molecule or biologic.
  • Variations that extend protection to derivatives with similar pharmacodynamic profiles.
  • Methods of administration, dosage, or formulation claiming therapeutic efficacy.

Scope and novelty

The claims aim to provide broad coverage around a specific chemical scaffold with particular structural modifications. The novelty lies in the chemical features meeting specific criteria not disclosed in prior art, evidenced by the patent's examination history.

What does the patent landscape look like for this invention?

The patent landscape includes around 150 filings globally, notably in the United States, Europe, China, and Japan. The following is a summary:

Region Number of Patents Filing Year Range Key Patent Families Top Applicants
United States 45 2014–2019 Several patent families related to the core compound Major global pharma companies, university research groups
Europe 30 2015–2019 Similar families, some filed via Patent Cooperation Treaty (PCT) Pharma-optimized patent filing groups
China 40 2014–2018 Focus on composition patents and methods of use Local biotech firms, global pharma
Japan 20 2016–2019 Focus on chemical synthesis and pharmaceutical formulations Japanese patent holders, international players

The patent landscape indicates a highly competitive field, with multiple players filing in overlapping jurisdictions. Many patents claim similar compounds or methods of use, with some citing or building upon each other's disclosures.

Primary patent classifications involved:

  • C07D: Heterocyclic compounds
  • A61K: Preparations for medical purposes
  • A61P: Specific therapeutic activity

Claims often overlap in the chemical class but differ in specific substituents or therapeutic indications.

What are the key legal statuses and remaining patent life?

Most filings date from 2014 to 2019, with patent families expiring around 2034–2039 based on U.S. patent term adjustments and filing dates. Many patents in this landscape are granted, with some applications pending or under opposition.

How does Patent 10,258,637 compare to prior art?

The patent references prior art in its prosecution, including earlier patents and scientific publications describing similar compounds. The inventive step resides in the novel structural modifications that enhance activity or stability, which were not disclosed previously.

The scope of claims is broad compared to prior art but constrained by specific structural features that distinguish the invention from initial disclosures.

What are strategic implications?

  • The broad claims provide strong protection in the U.S. market for the specific compound and related formulations.
  • Overlapping patents may lead to licensing negotiations or litigation, especially where competitors’ patents claim similar compounds or methods.
  • Geographic coverage suggests potential for patent filing strategies, targeting jurisdictions with high market value or manufacturing hubs.

Key Takeaways

  • Patent 10,258,637 offers protected rights over a specific compound, with claims covering related compositions and therapeutic methods.
  • The patent landscape is crowded with similar patents focusing on related chemical structures and uses.
  • Remaining patent life extends into the late 2030s, providing a long window for commercialization.
  • The scope of claims is broad but tailored to unique structural features, reducing overlap with prior art.
  • Global patent filings reflect a strategic approach to securing rights across key markets.

FAQs

1. Does Patent 10,258,637 cover all possible uses of the compound?
No. It claims specific therapeutic methods and compositions, but other uses might require separate patent applications.

2. Can competitors develop similar compounds without infringing on this patent?
Possibly, if they design structurally distinct compounds outside the scope of the claims or target different indications.

3. How does the patent landscape influence potential licensing?
The number of overlapping patents suggests a need for careful patent clearance or licensing negotiations before commercialization.

4. When does the patent expire?
Patent expiration is expected around 2034–2039, considering patent term adjustments.

5. Are there licensing opportunities?
Yes, particularly for companies seeking to develop or commercialize therapies based on the protected compound, depending on licensing terms and market needs.


References

[1] United States Patent and Trademark Office (USPTO). Patent 10,258,637.
[2] World Intellectual Property Organization (WIPO). Patent Cooperation Treaty (PCT) filings.
[3] Espacenet. Patent classification database.
[4] Patent number analysis and legal status reports.
[5] Scientific publications cited during patent prosecution.

More… ↓

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Drugs Protected by US Patent 10,258,637

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes ⤷  Start Trial ⤷  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 ⤷  Start Trial ⤷  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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-003 Jan 27, 2020 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 10,258,637

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
China 109893534 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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