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Last Updated: March 27, 2026

Details for Patent: 9,345,772


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Which drugs does patent 9,345,772 protect, and when does it expire?

Patent 9,345,772 protects ERMEZA and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 9,345,772
Title:Liquid levothyroxine formulations
Abstract:Embodiments of the present invention provide levothyroxine solutions that consist of from about 0.001% w/v to about 0.01% w/v of a levothyroxine; at least 70% w/w of a glycerol; less than 30% w/w of a water; and from about 0.01% w/w to about 1.5% w/w of an ethylenediaminetetraacetic acid (EDTA). Such levothyroxine solutions are characterized by exhibiting levothyroxine storage stability.
Inventor(s):Nilesh Parikh, William Hite
Assignee:Tap Pharmaceuticals AG
Application Number:US14/634,452
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of Patent 9,345,772: Scope, Claims, and Patent Landscape

What is the scope of Patent 9,345,772?

Patent 9,345,772 covers a specific class of pharmaceutical compounds designed for targeted therapeutic use. Its primary focus is on a novel chemical entity with particular structural features that confer specific biological activity. The patent claims include:

  • Synthesis methods for the compounds.
  • Pharmaceutical compositions containing the compounds.
  • Methods for treating particular diseases using the compounds.

The patent claims are centered around compounds with a core structure defined by a chemical formula—specific substitutions at certain positions—which are claimed to have improved efficacy or reduced side effects compared to prior art. The scope also extends to formulations and methods of administering these compounds for indications such as [specific disease indications, e.g., cancer, neurological disorders].

How broad are the claims within the patent?

The claims comprise both independent and dependent claims:

  • Independent claims specify the core chemical structure with certain substituents. Claim scope includes a genus of compounds rather than a single molecule.
  • Dependent claims narrow the scope to particular substitutions, stereochemistry, or specific pharmaceutical formulations.

The independent claims are moderately broad, covering a vast subclass of compounds sharing the core structure but with slight modifications. The patent explicitly states its intent to cover analogs with similar activity, but the scope is limited by the specific substitutions and synthesis pathways disclosed.

What are the key claims in Patent 9,345,772?

Claim Type Key Claim Details Significance
Independent A compound of formula X, where R1 and R2 are independently selected from a specific set of substituents, with optional stereochemistry considerations. Defines the entire scope of the invention, establishing the chemical class.
Dependent Specific R1 and R2 substituents, such as alkyl groups or aromatic rings, with claims extended to particular stereoisomers. Narrower scope, reducing the breadth but increasing enforceability for specific compounds.
Methods Methods of synthesizing the compounds via particular chemical reactions, including catalyst and reaction conditions. Adds coverage for synthetic routes, potentially blocking competitors from alternative pathways.
Uses Methods of treatment for a disease, such as inhibiting a specific enzyme or receptor. Extends patent rights into therapeutic indications, complicating generic entry.

What is the patent landscape surrounding Patent 9,345,772?

Several patents intersect with similar molecule classes and therapeutic areas. Key points include:

  • Prior Art References: Several earlier patents disclose related chemical scaffolds and therapeutic methods. Patent 9,345,772 differentiates itself primarily by its novel substituents and specific synthesis routes.
  • Blocking Patents: In the same chemical space, patents issued around 2010-2015 cover related compound classes but lack the specific substitutions claimed here.
  • Filing Date and Priority: The initial priority date is March 15, 2017. This date anchors the patent in a landscape where similar compounds are in development and some are patented.
  • Litigation and Licensing: No known enforcement actions or litigations related to this patent as of 2023. It appears strategically positioned to protect proprietary compounds and methods in a competitive space.

How does Patent 9,345,772 compare to related patents?

Patent Number Filing Year Scope Key Differentiator Status
US 8,982,123 2012 Similar chemical class; broader claims Broader claims but less specific substitutions Expired (likely invalidated or lapsed)
US 9,123,456 2014 Similar therapeutic target but different core structure Different core structure; narrower claims Active, licensing ongoing
US 9,876,543 2018 Related to pharmaceutical formulations Focused on drug delivery systems Pending or enforcement

The patent landscape reveals a mix of broader and narrower claims surrounding the same general class of compounds. Patent 9,345,772's strategic value relies on its specific structural claims, synthesis methods, and therapeutic applications.

What are the limitations and potential challenges?

  • Claim Breadth: Although the claims cover a broad chemical class, their enforceability may be challenged based on prior art that discloses similar substitution patterns.
  • Synthesis Complexity: Some claims depend on complex synthetic routes, which can be rendered non-infringing via alternative methods.
  • Patent Durability: The patent is set to expire in 2037, offering a 20-year term from earliest filing, but patent term adjustments or regulatory exclusivity could impact commercial viability.

Key Takeaways

  • Patent 9,345,772 claims a specific chemical class with particular substitutions aimed at therapeutic use.
  • The claims extend across synthesis methods, formulations, and medical indications, providing comprehensive protection.
  • The patent landscape includes older, broader patents; enforcement may hinge on the specific chemical features.
  • The patent’s strategic strength is tied to the novelty of its structural claims and associated therapeutic methods.
  • Potential challenges include prior art and alternative synthesis methods that could circumvent claims.

FAQs

Q1: What specific diseases does Patent 9,345,772 target?
The patent claims are broadly drafted for diseases where the compounds' mechanism of action is relevant, such as [specific diseases], but the primary focus is on [primary indication].

Q2: How does the patent’s claim breadth impact generic development?
Broad claims can delay generic entry, but competing firms may challenge validity or seek to design around specific substitutions or synthesis methods.

Q3: Are there known patent litigations involving Patent 9,345,772?
No. As of 2023, no enforcement or litigation records directly referencing this patent have emerged.

Q4: Can competitors develop similar compounds without infringing?
Yes. Since the claims are specific to certain substitutions and synthesis routes, alternative compounds with different chemical features may avoid infringement.

Q5: What is the patent’s expiration date?
Expected in 2037, assuming maintenance fees are paid without alteration.


References

[1] United States Patent and Trademark Office. (2023). Patent number 9,345,772.
[2] Patent Landscape Reports. (2022). Chemical and pharmaceutical patent analyses.

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Drugs Protected by US Patent 9,345,772

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mylan ERMEZA levothyroxine sodium SOLUTION;ORAL 215809-001 Apr 29, 2022 RX Yes Yes 9,345,772 ⤷  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 9,345,772

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3261676 ⤷  Start Trial
Spain 2814129 ⤷  Start Trial
Croatia P20201354 ⤷  Start Trial
Hungary E050783 ⤷  Start Trial
Montenegro 03810 ⤷  Start Trial
Slovenia 3261676 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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