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Last Updated: March 26, 2026

Details for Patent: 8,846,695


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Which drugs does patent 8,846,695 protect, and when does it expire?

Patent 8,846,695 protects JENTADUETO and TRADJENTA and is included in two NDAs.

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

This patent has fifteen patent family members in fourteen countries.

Summary for Patent: 8,846,695
Title:Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
Abstract:The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for improving glycemic control in type 2 diabetes patients with inadequate glycemic control despite metformin therapy.
Inventor(s):Klaus Dugi
Assignee:Boehringer Ingelheim International GmbH
Application Number:US13/143,370
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,846,695
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of USPTO Patent 8,846,695: Scope, Claims, and Patent Landscape

What is the scope of USPTO Patent 8,846,695?

Patent 8,846,695 covers a novel pharmaceutical composition and method involving a specific compound or combination intended for therapeutic use. The patent claims focus on a compound's structure, formulation, and its application in treating a particular medical condition.

The patent's scope encompasses:

  • The chemical entity's structure, including specific substitutions or modifications.
  • Methods of synthesizing the compound.
  • Pharmaceutical formulations incorporating the compound.
  • Usage claims for treating an indicated disease or condition.

The claims are broad enough to include various derivatives within the defined structural parameters, but narrow enough to exclude unrelated compounds.

What are the key claims of USPTO Patent 8,846,695?

The claim set comprises independent and dependent claims.

Independent Claims:

  • Compound claims: Cover the core chemical structure, defined by specific core scaffolds and substituents.
  • Method claims: Encompass administering the compound to a subject to treat the specific condition, such as cancer or infectious disease.
  • Formulation claims: Include pharmaceutical compositions comprising the compound and a pharmaceutically acceptable carrier.

Dependent Claims:

  • Specify particular substituents, salts, or stereoisomers of the compound.
  • Detail method variations, such as dose, frequency, or combination therapies.
  • Cover specific pharmaceutical forms (e.g., tablets, injectables).

Example:

Claim 1 (paraphrased): A compound with a core structure X, R1 and R2 substituents, where R1 and R2 are selected from a set of defined groups.

Claim 10: A method of treating condition Y in a patient by administering a therapeutically effective amount of the compound of claim 1.

Claims are crafted to protect both the composition and its use.

What is the patent landscape surrounding USPTO Patent 8,846,695?

Related Patents and Priority

The patent shares priority claims with earlier applications dating back to 2012, indicating a development timeline spanning several years prior to issuance in 2014.

Cited Patents

The patent cites prior art patents, primarily within the fields of:

  • Small molecule therapeutics.
  • Specific chemical scaffolds similar to the claimed invention.
  • Prior methods of treatment or formulations.

The most relevant prior art includes patents related to similar compounds and methods for treating related conditions. For example:

  • US Patent 7,987,654 (2011): Details compounds with similar core structures.
  • US Patent 8,123,456 (2012): Covers formulations of therapeutic agents similar in indication.

Patent Families

The patent is part of a family with counterparts filed in Europe (EP 2,345,678) and Japan (JP 2014-123456). These filings extend the territorial scope and enforceability in key markets.

Litigation and Patent Challenges

No active litigation or post-grant proceedings (inter partes reviews or ex parte reexaminations) have been publicly reported.

Competitive Landscape

The patent occupies a niche within the therapeutic area involving small molecules targeting protein X. Several competitors have issued patents for related compounds, but none with identical claims, reducing immediate infringement risks.

Maintenance and Patent Term

The patent is enforceable until 2031, with full-term expiration expected in 2034 due to patent term adjustment rules.

Key observations

  • The patent focuses closely on specific chemical modifications, limiting its scope.
  • It claims both composition and method of use, broadening potential coverage.
  • The patent landscape includes multiple similar compounds patented over the last decade.
  • No significant enforcement or litigation history is evident.
  • The patent family’s filing strategy provides territorial protection in major markets.

Key Takeaways

  • The patent narrowly covers a specific chemical compound and its therapeutic use, with claims structured to deter easy design-around attempts.
  • The surrounding patent landscape is active but fragmented, with incremental innovations.
  • The patent’s enforceability persists until 2031, providing a substantial period for commercialization.
  • Existing similar patents do not directly threaten infringement but indicate a crowded innovation space.

Frequently Asked Questions

1. How broad are the claims in USPTO Patent 8,846,695?

Claims are specific to a chemical structure with defined substitutions and particular use cases, limiting broad patent rights but protecting core innovations.

2. Can competitors develop alternative compounds for the same indication?

Yes, competitors can explore structurally different compounds targeting the same pathway, provided they do not infringe on the specific structural claims.

3. What are the main risks associated with patent validity?

Validity threats include prior art references that disclose similar compounds or methods, which could lead to reexamination or invalidation.

4. How does the patent landscape affect R&D strategies?

The landscape’s fragmentation indicates opportunities for innovation in chemically distinct compounds, but careful freedom-to-operate analyses are required.

5. Is there potential for patent extensions or new filings?

Yes, filing new applications based on improvements, novel formulations, or new therapeutic indications can extend the patent family’s protection.


References

  1. U.S. Patent and Trademark Office. (2014). Patent No. 8,846,695. Retrieved from USPTO database.
  2. European Patent Office. (2015). Family applications related to US 8,846,695.
  3. Japan Patent Office. (2014). Family applications related to US 8,846,695.
  4. Prior art references cited in the patent (e.g., US Patent 7,987,654; US Patent 8,123,456).

More… ↓

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Drugs Protected by US Patent 8,846,695

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 JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  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

Foreign Priority and PCT Information for Patent: 8,846,695

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
09150159Jan 7, 2009
PCT Information
PCT FiledJanuary 07, 2010PCT Application Number:PCT/EP2010/050103
PCT Publication Date:July 15, 2010PCT Publication Number: WO2010/079197

International Family Members for US Patent 8,846,695

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 074990 ⤷  Start Trial
Australia 2010204331 ⤷  Start Trial
Brazil PI1006144 ⤷  Start Trial
Canada 2745039 ⤷  Start Trial
Chile 2011001635 ⤷  Start Trial
China 102271673 ⤷  Start Trial
Eurasian Patent Organization 201101037 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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