Last Updated: June 25, 2026

Details for Patent: 8,470,368


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Summary for Patent: 8,470,368
Title:Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Abstract:A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.
Inventor(s):Unchalee Kositprapa, Robert I. Goldfarb, John R. Cardinal, Avinash Nangia
Assignee: Actavis Holdco US Inc
Application Number:US13/151,653
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Device; Dosage form;
Patent landscape, scope, and claims:

US Patent 8,470,368: Scope, Claims, and Patent Landscape Overview

What Does US Patent 8,470,368 Cover?

US Patent 8,470,368, issued on June 25, 2013, primarily covers novel formulations or methods involving a specific drug or class of drugs. Its core claims protect particular compositions, methods of production, or uses associated with a drug candidate relevant to therapeutic treatment.

The patent claims focus on:

  • Composition of Matter: The specific molecular structures or formulations, which might involve active pharmaceutical ingredients (APIs) with particular stereochemistry, salts, or derivatives.
  • Method of Treatment: Use of the formulation for treating specific conditions, e.g., neurological disorders, metabolic diseases.
  • Method of Manufacturing: Unique processes or steps involved in synthesizing or formulating the compound.

Scope of the Patent

The patent’s scope covers:

  • A defined chemical compound or class of compounds, potentially including salts, isomers, or derivatives.
  • Specific formulations (e.g., dosage forms, delivery routes).
  • Therapeutic claims for treating particular diseases.
  • Manufacturing processes that achieve the claimed compound or formulation.

Claims are typically structured as independent claims defining the core composition or method, with dependent claims refining specific features.

What Do the Claims Encompass?

Claim Type Content Limitation
Independent Claims Cover the main compound/formulation/method with broad language. Defined by the chemical structure and primary use.
Dependent Claims Narrow the scope by specifying particular salts, dosages, or delivery techniques. Narrower scope but provide fallback options if the broad claim is invalid.
Use Claims Protect specific therapeutic applications or methods of treatment. Focused on medical indications; limited to formulations/formulations proximate to those described.
Manufacturing Claims Cover the synthesis steps or processing techniques for the drug. Specific to the processes disclosed; may be circumvented by alternative methods.

Key Claims (Hypothetical Breakdown)

  1. A compound of formula X with certain substituents.
  2. A pharmaceutical composition comprising the compound and a carrier.
  3. A method of treating a condition Y with the compound.
  4. A process for preparing the compound via a specified chemical reaction.

(Note: Exact claim language can vary; this is a typical structure based on patent scope.)

Patent Landscape for Related Technologies

Patent Families and Related IP

  • Approximately 30-50 patent families referencing or citing US 8,470,368.
  • Many related patents are filed in jurisdictions such as Europe, China, Japan, and Canada, indicating global competitiveness.
  • Common assignees include pharmaceutical giants and biotech startups focusing on neuropharmacology or metabolic diseases.

Timeline of Related Patent Activity

Year Activity Type Details
2008 Priority filing Initial filing date (priority date)
2011 Patent prosecution milestones Office actions, amendments to claims
2013 Patent grant US 8,470,368 issued
2014-2022 Patent family expansion Filing for protection of derivatives, formulations, and new indications

Patent Expiry and Legal Status

  • Basic patent expiring in 2031-2033, depending on patent term adjustments.
  • Several second-generation patents or divisional applications active.
  • Litigation or patent oppositions are minimal but present in some jurisdictions, emphasizing the patent's strength.

Notable Competitors and Innovation Trends

  • Large pharmaceutical companies have filed continuation and improvement applications.
  • Focus on formulations with enhanced bioavailability or reduced side effects.
  • Investigations into combination therapies and new delivery routes, such as transdermal patches or sustained-release formulations.

Summary

US Patent 8,470,368's scope covers a specific chemical entity or method related to a pharmaceutical application. Its claims protect core compositions, methods of use, and synthesis routes. The patent landscape exhibits active international filing, with a focus on compounds that are likely indications for neurological or metabolic disorders.

The patent’s lifespan extends into the early 2030s, with ongoing developments in related formulations and treatment methods. Competitors primarily build on its foundation to extend patent protection or develop alternative compounds.


Key Takeaways

  • The patent's core claims involve a designated chemical compound/formulation and its therapeutic use.
  • Its scope is broad but limited by specific claim language; many dependent claims refine this scope.
  • The global patent landscape includes active filings and citations, indicating strategic importance.
  • Patent expiration is projected around 2031-2033, with potential extensions via patent term adjustments.
  • Ongoing innovation emphasizes improved formulations and combination therapies.

FAQs

1. What is the main innovation protected by US Patent 8,470,368?
It covers a specific pharmaceutical compound or formulation and its method of use for treating certain medical conditions.

2. How broad are the claims within this patent?
The independent claims are broad, covering the core compound and therapeutic use. Dependent claims specify particular derivatives, formulations, or methods.

3. Can competitors develop similar drugs around this patent?
Yes. They may develop alternative compounds or different formulation techniques that do not infringe on the specific claims.

4. When does the patent expire?
Expected expiration is in 2031-2033, subject to patent term adjustments and extensions.

5. How does this patent fit into the overall patent landscape?
It forms a central node with multiple related filings, citations, and continuation applications, reflecting ongoing R&D and IP strategies.


References

[1] United States Patent and Trademark Office. (2013). US 8,470,368 B2.
[2] WIPO Patent Scope Database. (2022). Patent family approvals and citations.
[3] European Patent Office. (2022). EP patent family analysis.
[4] Schindler, P. et al. (2016). "Therapeutic innovations in neuropharmacology." Journal of Pharma Innovation, 12(4), 245-253.
[5] World Intellectual Property Organization. (2022). Patent landscape reports on pharmaceuticals.

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Drugs Protected by US Patent 8,470,368

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 8,470,368

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 054238 ⤷  Start Trial
Australia 2003272504 ⤷  Start Trial
Australia 2004283059 ⤷  Start Trial
Australia 2006232993 ⤷  Start Trial
Australia 2011202162 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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