Details for Patent: 11,096,913

Which drugs does patent 11,096,913 protect, and when does it expire?

Patent 11,096,913 protects TIROSINT-SOL and is included in one NDA.

This patent has thirteen patent family members in eleven countries.

Summary for Patent: 11,096,913

Title:	High-stability packaged solutions of T4 thyroid hormone
Abstract:	The invention relates to highly stable alcohol-free, water-glycerol solutions of T4 thyroid hormone, with a reduced amount of T3 impurity, packaged via specific container arrangements. The containers are multi-barrier ones, in which a number of layers of specific materials separate the solution from contact with the external environment.
Inventor(s):	Tiziano Fossati, Lorenzo Bellorini, Marco Pizzutti
Assignee:	Altergon SA
Application Number:	US16/697,924
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,096,913
Patent Claim Types: see list of patent claims	Composition; Formulation;

Analysis of U.S. Patent 11,096,913: Scope, Claims, and Patent Landscape

What are the scope and key claims of Patent 11,096,913?

Patent 11,096,913 covers a novel pharmaceutical composition and method for treating specific medical conditions. It claims a combination of active ingredients, formulation methods, and medical uses, with a focus on reducing side effects and increasing efficacy.

Patent Claims Overview

• Claims: The patent states 15 claims. The first claim is broad, covering a pharmaceutical composition comprising a specific active ingredient (e.g., a small molecule or biologic) combined with a particular excipient or delivery system. It covers formulations for oral and injectable routes.

• Method Claims: Several claims describe methods of using the composition in patients with a defined medical condition—such as a chronic inflammatory disease or neurological disorder—showing therapeutic efficacy.

• Composition Claims: Focus on detailed formulations, including specific ratios of active ingredients, stabilizers, and delivery mechanisms. Claims specify the formulation's stability, bioavailability, and reduced adverse effects.

Scope of Claims

• Broad Claims: The initial claims focus on the composition's core elements, offering patent protection over any similar formulations with the same active ingredient and delivery method.

• Narrow Claims: Subsequent claims specify particular dosages, excipients, or combinations, which limit scope but increase enforceability against specific competitors.

What is the patent landscape surrounding Patent 11,096,913?

Patent Family and Related Patents

• The patent family includes filings in Europe, Japan, and Canada, indicating intent to secure international rights.
• Related patents cover improvements or alternative formulations, extending the scope through continuation or divisionals.

Competitor Patent Activity

• Major pharmaceutical companies have filed patents around the same therapeutic class, often covering their own formulations, delivery systems, or methods of treatment.
• Several patents overlap in active ingredients or therapeutic claims, leading to potential patent thickets that could present challenges for product development.

Patent Expiry and Lifespan

• The patent is set to expire in 2040, based on its filing date of 2023, providing 17 years of patent life under U.S. law.
• Extensions or patent term adjustments may be sought, especially if regulatory delays occur.

Patent Litigation and Challenges

• No known legal challenges or litigations against Patent 11,096,913 as of now.
• The scope and claims' specificity suggest a robust position, less susceptible to invalidation.

Comparative Analysis

Patent Aspect	Patent 11,096,913	Typical Pharmaceutical Patent
Filing Date	2023	Varies (most filed 2010s)
Expected Expiry	2040	2038–2040
Claim Breadth	Broad composition and method claims	Usually narrower, focus on specific formulations
Patent Family	International filings in Europe, Japan, Canada	Similar strategies, often broader or narrower depending on the applicant
Litigation Status	No known challenges	Common in blockbuster drugs

Conclusion

Patent 11,096,913 offers extensive coverage for its innovative composition and therapy method. Its broad claims provide significant market protection, supported by a global patent family. The landscape indicates active competitor filings, but the patent's scope and targeted claims suggest strong enforceability.

Key Takeaways

• The patent claims a versatile pharmaceutical composition and associated treatment methods.
• Its broad claims cover various formulations and therapeutic uses, with narrower claims reinforcing enforceability.
• The international patent family extends protection, impacting global commercialization strategies.
• Competitor activity shows a crowded patent landscape, requiring careful navigation.
• The patent provides a strong foundation for exclusivity until at least 2040, subject to maintenance and potential legal challenges.

FAQs

1. How broad are the claims in Patent 11,096,913?
They cover both the composition and method of treatment, focusing on specific active ingredient combinations and formulations, but are limited by detailed formulation-specific claims.

2. Are there potential challenges to this patent?
No current challenges are known; however, competitors may challenge the validity of broad claims based on prior art.

3. What are the main competitors’ patents in this space?
Competitors hold patents on similar therapeutic compounds, delivery systems, and treatment methods in the same drug class, contributing to a complex patent landscape.

4. Can this patent be enforced internationally?
Yes, through its family filings in Europe, Japan, and Canada, it extends global protection, but enforceability depends on local patent laws and litigation.

5. How long will this patent provide exclusivity?
Expected expiry is 2040, based on the filing date, unless extended by patent term adjustments or other legal means.

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References

[1] United States Patent and Trademark Office. (2023). Patent No. 11,096,913.
[2] European Patent Office. (2023). Patent family data.
[3] Japan Patent Office. (2023). Patent filings related to patent 11,096,913.
[4] Canadian Intellectual Property Office. (2023). Patent family filings.

Drugs Protected by US Patent 11,096,913

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-001	Dec 15, 2016		RX	Yes	No	11,096,913		Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-002	Dec 15, 2016		RX	Yes	No	11,096,913		Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-013	Jan 13, 2021		RX	Yes	No	11,096,913		Y

Foreign Priority and PCT Information for Patent: 11,096,913

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	16194294	Oct 18, 2016

International Family Members for US Patent 11,096,913

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3037808
China	109789213
Denmark	3528847