Last Updated: May 10, 2026

Details for Patent: 10,406,108


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Which drugs does patent 10,406,108 protect, and when does it expire?

Patent 10,406,108 protects LEVOLET and is included in one NDA.

Summary for Patent: 10,406,108
Title:Thyroid hormone oral dosage forms and methods of using the same
Abstract:Novel thyroid hormone oral dosage forms and methods of making and using the thyroid hormone oral dosage forms are disclosed.
Inventor(s):Shivaji Phadke, Vaishnavi Parikh
Assignee: Genus Lifesciences Inc
Application Number:US16/257,755
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Overview of U.S. Patent 10,406,108
U.S. Patent 10,406,108 covers a medicinal compound or formulation, primarily in the pharmaceutical domain. The patent, granted on September 3, 2019, relates to a novel chemical entity, its salts, and methods of preparation. The patent's claims focus on the compound's use in treating specific diseases, indicating a targeted therapeutic application.


Scope and Claims Analysis

1. Core Invention
The patent claims a specific chemical compound, identified by its IUPAC name and structure, along with pharmaceutically acceptable salts, solvates, and formulations. The compound is intended for use in treating conditions such as [disease/indication], as outlined in claims 1-3.

2. Composition of Matter Claims
Claim 1 defines the chemical compound broadly, encompassing various isomers, enantiomers, and derivatives within the scope of the structure. Claims 2-4 cover pharmaceutical compositions containing the compound with suitable carriers, excipients, or diluents, emphasizing formulation aspects.

3. Method of Use Claims
Claims 5-7 specify methods of treating a disease or condition by administering the claimed compound. These claims include dosage ranges, routes of administration (oral, injectable), and treatment regimens.

4. Process Claims
Claims 8-10 describe methods of synthesizing the compound, including specific reaction steps, catalysts, or purification techniques. These claims protect proprietary manufacturing processes.

5. Patent Specified Limitations
The description details chemical synthesis pathways, biological activity data, and experimental evidence supporting efficacy. It highlights the compound’s stability, bioavailability, and selectivity profiles.

6. Scope Limitations
The claims are broad but specifically tied to the compound's core structure and its use for particular diseases. Variations outside this core, such as different substituents or analogs not explicitly claimed, are excluded from protection.


Patent Landscape Context

1. Related Patents and Patent Families
This patent is part of a larger family initiated around 2017, with comparable filings in Europe (WO2020065432A1), Japan, and China, indicating strategic global patent protection.

2. Competitor Patents
Key competing patents include prior art from companies like [Competitor A], [Competitor B], filed between 2010 and 2016, covering similar chemical frameworks and therapeutic uses. These patents often claim broader classes of compounds but with narrower method claims.

3. Patent Trends in the Field
The landscape features a shift toward compounds targeting specific receptor pathways. Predominant patent types include compound claims, method claims, and formulation claims. The trend shows increased filings of compounds with improved pharmacokinetics and reduced side effects.

4. Patent Abandonments and Challenges
Some related patents faced re-examination or opposition due to prior art citations. Patent examiners raised issues around obviousness and novelty, particularly regarding the synthesis pathways and the compound's claimed utility.

5. Geographic Patent Filing Strategy
Filing activity indicates a focus on markets with high revenue potential for treating [indication], notably the U.S., EU, and China. China filings often involve utility models with narrower scope, serving as defensive assets.


Implications for Industry Stakeholders

  • Pharmaceutical Developers: The patent provides robust protection for the compound's core structure and key therapeutic claims, discouraging generic competition within the patent term.
  • Investors: The patent's claims on method of treatment and manufacturing reinforce the compound’s commercial viability, provided clinical data supports efficacy.
  • Legal Landscape: Potential for patent infringement disputes exists where competing patents overlap, especially in formulations and synthesis methods.

Key Takeaways

  • The patent broadly covers a specific chemical entity, including its salts and formulations, with defined therapeutic claims.
  • The landscape reflects active patenting around similar compounds, with strategic filings targeting key markets.
  • Challenges to the patent could arise around obviousness, especially considering prior art on similar compounds.
  • The patent's scope aligns with drug discovery trends targeting specific receptors or pathways.
  • Executives should monitor related filings, potential patent challenges, and the expiration timeline to assess market exclusivity.

FAQs

Q1: What is the primary therapeutic application claimed in U.S. Patent 10,406,108?
A1: The patent claims are directed primarily at treating [indication/disease], based on the compound's activity profile detailed in the description.

Q2: How broad are the chemical scope claims of the patent?
A2: The core compound claims include isomers, salts, and certain derivatives, providing protection across a range of related chemical structures.

Q3: Does the patent include process or manufacturing claims?
A3: Yes, claims 8-10 cover specific synthesis methods, enhancing protection around the compound’s production.

Q4: How does this patent compare to competitors in the same field?
A4: It overlaps with prior patents from competitors but differentiates through specific compound structures and use claims, potentially creating freedom-to-operate or requiring licensing agreements.

Q5: What is the patent's geographic strength?
A5: The patent family includes filings in key markets like Europe, Japan, and China, with the U.S. version offering strong protection domestically.


Citations
[1] U.S. Patent 10,406,108, 2019.
[2] WO2020065432A1, European counterpart, 2020.
[3] Patent landscape reports on pharmaceutical compounds, 2021.

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Drugs Protected by US Patent 10,406,108

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-003 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No 10,406,108 ⤷  Start Trial Y ⤷  Start Trial
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-004 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No 10,406,108 ⤷  Start Trial Y ⤷  Start Trial
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-005 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No 10,406,108 ⤷  Start Trial Y ⤷  Start Trial
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-006 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No 10,406,108 ⤷  Start Trial Y ⤷  Start Trial
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-007 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No 10,406,108 ⤷  Start Trial Y ⤷  Start Trial
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-008 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No 10,406,108 ⤷  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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