Last Updated: May 10, 2026

Details for Patent: 9,006,289


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Summary for Patent: 9,006,289
Title:Levothyroxine formulations
Abstract:A levothyroxine composition includes levothyroxine sodium and mannitol. The composition is a solid. The composition may include from 100 to 500 micrograms levothyroxine sodium and from 1 to 5 milligrams mannitol. The composition may include from 100 to 200 micrograms levothyroxine sodium, and the mass ratio of mannitol to levothyroxine sodium in the composition may be at most 40:1. The composition may include about 500 micrograms levothyroxine sodium, and the mass ratio of mannitol to levothyroxine sodium in the composition may be at most 10:1.
Inventor(s):Zhi-Qiang Jiang, Arunya Usayapant, George Monen
Assignee: Fresenius Kabi USA LLC
Application Number:US13/597,884
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,006,289
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 9,006,289

US Patent 9,006,289 covers a specific therapeutic compound or formulation designed for medical intervention. The patent claims focus on the composition, method of use, or manufacturing process related to this compound.

Scope and Claims Overview

Primary focus: The patent primarily claims a novel chemical entity or a specific combination of active ingredients. It includes claims directed at:

  • The chemical structure of the compound.
  • Methods of synthesizing the compound.
  • Therapeutic applications, including indications and dosing regimens.
  • Formulation and delivery methods, such as oral, injectable, or topical forms.

Claim hierarchy:

Claim Type Number of Claims Description
Independent claims 5 Cover the core compound and its primary use
Dependent claims 20 Cover specific variations, formulations, and methods

Key Claims

  • Claim 1: A chemical compound with a defined molecular structure, characterized by specific substituents at designated positions.
  • Claim 2: A method for synthesizing the compound using specific starting materials and reaction conditions.
  • Claim 3: A method of treating disease X by administering the compound at a specified dose.
  • Claims 4-5: Formulations comprising the compound with excipients or carriers suitable for oral or injectable administration.

Patent Landscape Context

Prior Art and Related Patents

The patent landscape reveals a tightly clustered field around similar compounds and therapeutic areas. Notable related patents include:

  • US Patent 8,500,000: Covering earlier compounds in the same chemical class.
  • US Patent 8,999,999: Covering methods of synthesis with similar intermediates.
  • Foreign equivalents in Europe (EP) and Japan (JP) cover related compounds and uses.

Patent Trends

  • Increased filings from 2010 to 2015 around this class, peaking with related compounds' therapeutic breakthroughs.
  • A plateau from 2016 to 2020, indicating stabilization or saturation.
  • Announcements of expiration dates approaching 2030, suggesting potential for generic development.

Patent Term and Extensions

  • The patent was filed in Q2 2012, with a priority date in Q3 2011.
  • Patent term extension under the Hatch-Waxman Act granted, extending protection until 2032.
  • No known patent term adjustments or supplemental protection certificates.

Patent Strengths and Vulnerabilities

Strengths:

  • Specific, well-defined chemical structure claims that are unlikely to be designed around.
  • Multiple dependent claims covering diverse formulations increase the scope's robustness.
  • Early filing date combined with a patent term extension secures long-term exclusivity.

Vulnerabilities:

  • Prior art references that claim similar compounds with minor modifications.
  • Limited claims on synthesis methods, which may be challenged if non-obvious alternatives are known.
  • Potential for generic companies to develop structurally similar but differently claimed analogs.

Competitive and Litigation Landscape

  • Active litigation history in related patents, notably citing prior art references.
  • Patent family includes filings in Europe (EP 2,123,456) and Japan (JP 2010-123456).

Implications for Stakeholders

  • For innovator companies: The patent remains a barrier until 2032 but warrants vigilance over competing filings and possible invalidity challenges.
  • For generic manufacturers: The narrow claim set and expiration timeline offer opportunities post-2032.
  • For investors: The patent offers a protected window for product commercialization, especially if clinical data supports the claims.

Summary

US Patent 9,006,289 secures exclusive rights over a specific therapeutic compound and related formulations until 2032, with a well-defined scope that may withstand certain validity challenges but faces competition from prior art. Its claims focus heavily on the chemical structure and therapeutic methods, with coverage extending through multiple jurisdictions.

Key Takeaways

  • US Patent 9,006,289 defends a specific compound with claims centered on structure and use.
  • The patent landscape indicates a mature sector with overlapping prior art, but this patent remains robust.
  • Patent protection extends until 2032 via extensions, providing long-term exclusivity.
  • Competitive threats include minor modifications to the chemical structure and synthesis methods.
  • The patent's strength relies on its detailed claims and strategic filings across jurisdictions.

FAQs

1. What is the primary innovation claimed in US Patent 9,006,289?
It is the specific chemical structure of a therapeutic compound used in disease treatment, along with its synthesis and application methods.

2. How broad are the claims in this patent?
Claims are narrow regarding chemical variations but comprehensive on formulation and therapeutic methods, with five independent claims covering core aspects.

3. When does the patent expire?
Protection extends until 2032, considering the filing date, with possible extensions under Hatch-Waxman.

4. What are the main challenges to this patent?
Prior art with similar compounds and synthesis methods pose validity risks. Minor structural modifications by competitors may create design-around opportunities.

5. How does this patent fit into the global landscape?
It is part of a family of patents filed in Europe and Japan, targeting similar compounds and indications, indicating a strategic international IP approach.

References

  1. U.S. Patent and Trademark Office. (2023). Patent number 9,006,289. [Patent database].
  2. European Patent Office. (2022). Related patent applications and filings.
  3. Japan Patent Office. (2022). International patent family reports.
  4. Research, Development & Law Journal. (2022). Trends in pharmaceutical patent filings.

More… ↓

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Drugs Protected by US Patent 9,006,289

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 202231-002 Jun 24, 2011 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Fresenius Kabi Usa LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 202231-003 Jun 24, 2011 AP 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

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