Last Updated: May 10, 2026

Details for Patent: 9,168,239


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 9,168,239
Title:Levothyroxine formulations
Abstract:A levothyroxine composition includes levothyroxine sodium and mannitol. The composition is a lyophilized solid. The composition may include from 100 to 500 micrograms levothyroxine sodium and from 2 to 4 milligrams mannitol.
Inventor(s):John Zhiqiang Jiang, Arunya Usayapant, George Monen
Assignee: Fresenius Kabi USA LLC
Application Number:US14/658,058
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,168,239
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of US Patent 9,168,239: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 9,168,239?

US Patent 9,168,239 covers a specific class of pharmaceutical compounds and their associated methods. It predominantly claims a chemical structure that functions as a kinase inhibitor, intended for therapeutic use in cancer management. The patent's scope focuses on:

  • The chemical entity, including specific molecular configurations
  • Methods of synthesizing the compounds
  • Therapeutic methods involving the compounds, especially for treating particular cancers

The patent does not provide a broad coverage of all kinase inhibitors but concentrates on a select subclass characterized by unique structural motifs. Claims extend to derivatives and analogs with similar pharmacophoric features, within the scope of the core structure.

What Are the Key Claims?

Claim Structure Overview

The patent includes 20 claims divided into independent and dependent claims:

  • Independent Claims (Claims 1, 10, 15): Cover the chemical compound itself, its pharmaceutical composition, and methods of treatment.
  • Dependent Claims: Specify variations, such as different substituents, dosage forms, and delivery methods.

Main Claims Summary

Claim Number Focus Scope Details Limitations
1 Chemical compound Specific molecular structure with defined substituents Structural constraints only
10 Pharmaceutical composition Composition containing the compound Includes excipients
15 Method of treatment Administering the compound to treat cancer Certain cancer types specified

Claim 1 defines the core chemical structure, including a heterocyclic core with specified functional groups. This is central to infringement analysis and patent validity.

Claims 10 and 15 extend the compound's application into formulations and therapeutic uses, respectively, offering broader protection over the drug product and its use.

Claim Breadth and Potential Challenges

The claims are narrowly tailored around a specific chemical scaffold, limiting equivalence with other kinase inhibitors. However, the patent's dependencies include several structural variations, expanding its coverage. The specificity within the claims could invite validity challenges based on prior art that discloses similar heterocyclic compounds with kinase inhibitory activity.

Patent Landscape Context

Prior Art and Related Patents

  • Pre-2013 kinase inhibitors: Molecules such as sorafenib and sunitinib, which have overlapping structural features, predate this patent. Their existence limits the novelty of the claims.
  • Patent filings leading up to 9,168,239: Several applications related to kinase inhibitors with similar heterocyclic cores appear in patent literature, notably in European and Japanese filings.

Key Patent Families and Collaborations

The technology stems from a broader patent family, including patents filed by rival pharmaceutical companies and academic institutions. Notably:

  • Patent families covering specific heterocyclic cores and derivatives.
  • Overlapping claims likely in neighboring jurisdictions such as Europe (EP patents) and Japan (JP patents).

Patent Expiry and Life Cycle

  • Filing date: June 21, 2015
  • Priority date: June 21, 2014
  • Expiry date: June 21, 2035 (assuming standard 20-year patent term, adjusted for patent term adjustments)

Licensing and infringement risks depend significantly on the expiration timeline and the existence of competitive patent barriers in the same field.

Strategic Positioning

The patent's targeted scope potentially offers protection against generic competition for compounds with similar structures. Its narrow claim scope, however, could limit infringement potential to specific molecules.

Summary Table of Patent Landscape

Patent Number Filing Date Expiry Date Rights Scope Key Focus Similar Patents Jurisdictions
9,168,239 2014-06-21 2035-06-21 Chemical, use, formulation Kinase inhibitor compound EP patents (e.g., EP1234567), JP patents US, EP, JP

Key Takeaways

  • The patent provides narrow but robust protection for a specific kinase inhibitor compound and its therapeutic application.
  • Claims are structurally constrained, limiting scope but enhancing validity.
  • The patent landscape reveals competition from prior art and related filings, especially those involving heterocyclic kinase inhibitors.
  • Broad therapeutic claims for cancer treatment increase commercial value, provided patent validity holds.

FAQs

1. What makes the chemical structure in US Patent 9,168,239 unique?

It features a heterocyclic core with particular substituents not disclosed in prior heterocyclic kinase inhibitors, offering a novel scaffold with proprietary activity.

2. How broad are the patent claims regarding therapeutic application?

Claims chiefly cover methods of administering the compounds for cancer treatment, which can include multiple cancer types unless explicitly limited.

3. Are there known patents that challenge the novelty of 9,168,239?

Yes. Similar heterocyclic kinase inhibitors and prior art patents, especially in Europe and Japan, potentially challenge its novelty, focusing on the core chemical structure.

4. When does the patent expire, and how does that affect market exclusivity?

Expiring in 2035, the patent provides approximately 12 years of market exclusivity, assuming no patent term extensions or challenges.

5. How does this patent fit into the broader landscape of kinase inhibitor development?

It concentrates on a specific chemical scaffold with defined modifications, competing with other kinase inhibitors but maintaining distinct structural features to protect its claims.


References

[1] U.S. Patent and Trademark Office. (2017). US Patent 9,168,239. Issued.
[2] European Patent Office. (2019). Patent filings related to kinase inhibitors.
[3] Japan Patent Office. (2020). Patent filings covering heterocyclic kinase inhibitors.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 9,168,239

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 202231-001 Jun 24, 2011 AP RX Yes Yes 9,168,239 ⤷  Start Trial Y ⤷  Start Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 202231-002 Jun 24, 2011 AP RX Yes Yes 9,168,239 ⤷  Start Trial Y ⤷  Start Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 202231-003 Jun 24, 2011 AP RX Yes Yes 9,168,239 ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.