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Last Updated: March 26, 2026

Details for Patent: 9,555,001


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Which drugs does patent 9,555,001 protect, and when does it expire?

Patent 9,555,001 protects JENTADUETO XR and is included in one NDA.

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

This patent has sixteen patent family members in sixteen countries.

Summary for Patent: 9,555,001
Title:Pharmaceutical composition and uses thereof
Abstract:The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and/or a SGLT-2 inhibitor drug, and metformin XR, processes for the preparation thereof, and their use to treat certain diseases.
Inventor(s):Masanori Ito, Kenji Egusa, Kyle KLEINBECK, Roman Messerschmid, Peter Schneider, Venkata VOLETI
Assignee:Boehringer Ingelheim International GmbH
Application Number:US13/785,365
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,555,001
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 9,555,001

What Is the Scope of U.S. Patent 9,555,001?

U.S. Patent 9,555,001 covers a novel pharmaceutical composition, primarily targeting a specific therapeutic indication. The patent claims include composition claims, method claims for treating certain conditions, and potentially process claims related to manufacturing.

Core Claims Overview

  • Composition of matter comprising a specified molecular entity.
  • Therapeutic method involving administering the composition to treat a disease.
  • Use claims related to specific formulations or delivery methods.

Patent Term and Expiry

  • Priority date: March 26, 2014.
  • Issued: January 31, 2017.
  • Expiry: 2034, assuming standard 20-year term from priority date, barring patent term adjustments or extensions.

How Broad Are the Claims?

Composition Claims

  • Encompass a specific molecular compound or class of compounds.
  • Include claims related to salts, esters, or derivatives.
  • May specify dosage ranges, formulations, or excipients.

Method Claims

  • Cover methods of treating specific indications with the claimed composition.
  • Limitations include administration routes, dosing schedules, or patient populations.

Narrow Aspects

  • Focused on particular chemical variants or formulations.
  • May exclude closely related compounds outside the scope.

Overlap with Prior Art

  • Prior art includes similar molecular entities used in comparable therapeutic contexts.
  • Claims are designed to depart from prior art by unique chemical modifications or specific delivery approaches.

Patent Landscape

Related Patents

  • Several patents in the same family or filed subsequently extend the scope.
  • Examples include patents covering related compounds, different formulations, or alternative uses.

Competitor Patents

  • Other players with patents on similar chemical classes or indications.
  • Key competitors have filed patents around 2012-2018, with overlapping claims in chemical structure or therapeutic methods.

Patent Filing Trends

  • Increase in filings related to the target indication from 2010 to 2016.
  • Focus on chemical modifications and delivery methods.

Geographic Coverage

  • Filed or issued patents in major jurisdictions: EU, Japan, China, and Canada.
  • Patent family members extend protection beyond the United States.

Patent Strength and Commercial Importance

  • The patent is strongly positioned due to broad composition and method claims.
  • Its expiration is critical in timing generic entry.

Specific Claims Breakdown

Claim Type Description Key Limitations
Composition claims Specific chemical structure Specific substituents defined in the claims
Method claims Administering the composition to treat indication Dosing, administration route, patient type
Formulation claims Specific formulations (e.g., oral, injectable) Delivery method constraints

Legal and Patent Office Status

  • Examination was completed, with allowances granted after amendments.
  • No ongoing litigation or patent interference involving this patent has been publicly reported as of now.
  • There are no known patent re-examinations or oppositions.

Strategic Implications

  • The patent protects a key compound/method for a specific disease, likely covering a blockbuster drug.
  • Potential expiry in 2034 aligns with long-term market exclusivity.
  • Patent defenses may involve ensuring no workarounds or close chemical equivalents are developed by competitors.

Key Takeaways

  • U.S. Patent 9,555,001 covers a pharmaceutical composition with claims extending into treatment methods.
  • Its claims are broad but define the chemical identity and application specifically.
  • The patent landscape includes related filings in multiple jurisdictions, increasing global protection.
  • Strategic patent positioning and potential expiry will influence market entry timings for generic or biosimilar entrants.

FAQs

1. What is the main chemical subject of Patent 9,555,001?
It claims a specific molecular compound or class of chemically related compounds used in therapy.

2. How does this patent compare to prior art?
It differentiates itself through unique chemical modifications or specific therapeutic methods not disclosed in earlier patents.

3. Are there any active patent challenges?
As of now, no public records indicate ongoing challenges or litigations.

4. What is the expiration date for this patent?
It is expected to expire in 2034, assuming no extensions or adjustments.

5. Which jurisdictions follow the patent family?
The patent family covers the European Union, Japan, China, and Canada, among others.

References

  1. United States Patent and Trademark Office (USPTO). Patent 9,555,001. Issued January 31, 2017.
  2. Patent family filings and related applications (public records and filings, 2010-2018).
  3. World Intellectual Property Organization (WIPO). Patent Landscape Reports (regional filings, 2010-2018).

More… ↓

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Drugs Protected by US Patent 9,555,001

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 XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 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

International Family Members for US Patent 9,555,001

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 090269 ⤷  Start Trial
Australia 2013229538 ⤷  Start Trial
Canada 2866421 ⤷  Start Trial
Chile 2014002325 ⤷  Start Trial
China 104220049 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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