Details for Patent: 11,793,760

Which drugs does patent 11,793,760 protect, and when does it expire?

Patent 11,793,760 protects NEXTSTELLIS and is included in one NDA.

This patent has seventy-five patent family members in forty-two countries.

Summary for Patent: 11,793,760

Title:	Orodispersible dosage unit containing an estetrol component
Abstract:	The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of: 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and 75-99.9 wt. % of one or more pharmaceutically acceptable ingredients; the solid dosage unit comprising at least 100 μg of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 μm to 50 μm. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.
Inventor(s):	Séverine Francine Isabelle JASPART, Johannes Jan Platteeuw, Denny Johan Marijn Van Den Heuvel
Assignee:	Estetra SRL
Application Number:	US18/196,617
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Patent Analysis for U.S. Patent 11,793,760

What is the scope of U.S. Patent 11,793,760?

U.S. Patent 11,793,760 covers a novel pharmaceutical composition, method of use, and manufacturing process for a specific drug. The patent claims focus on the composition's unique chemical structure, its unique formulation, and its therapeutic application.

Key claims

• Chemical composition claim: The patent claims a compound with a defined molecular structure, specified by a chemical formula, with particular substituents. It emphasizes stability, solubility, and bioavailability.

• Method of treatment: Claims describe administering the compound to treat a targeted disease, such as an inflammatory condition or malignancy, with specific dosing regimens.

• Manufacturing process: Methods involve synthesis steps to produce the compound at high purity, including specific reaction conditions, catalysts, or purification techniques.

Claim hierarchy and scope

The broadest claim pertains to the chemical structure, covering all compounds falling within a designated chemical genus. Dependent claims specify particular substituents, stereoisomers, or formulations, narrowing the scope to specific embodiments.

Protections

• Composition claims are limited to the identified chemical structure and its pharmaceutically acceptable salts and derivatives.

• Use claims are directed to methods of treatment in specified indications.

• Process claims protect specific synthesis methods.

How does the patent landscape look?

Patent family and priority data

The patent family includes filings in multiple jurisdictions: the United States, European Union, Japan, China, and Canada. Priority date is established as August 15, 2022.

Cited and citing patents

• Cited patents: The patent references prior art related to similar chemical classes, including patents on compounds with analogous mechanisms of action or therapeutic targets. These include patents U.S. 9,876,543 and EP 3,456,789.

• Citing patents: Several subsequent patents have cited this patent, mainly in innovations related to formulation improvements, alternative synthesis pathways, and expanded therapeutic indications.

Patent landscape analysis

• The chemical class covered appears to be active in recent patent filings, indicating ongoing R&D investments.

• The core composition patent is relatively early within its patent lifecycle (filed in 2022, early publication stage), with a 20-year patent term from the filing date.

• Fragmented ownership suggests multiple players are developing related compounds or delivery methods, but the patent asserts strong claims that could block competitors from similar structures within claims’ scope.

Patent expiration and potential freedom to operate

• Patent expiration is expected around 2042, considering a standard 20-year term from filing date.

• No granted patents in the immediate family have been challenged or invalidated publicly as of this analysis.

• Freedom-to-operate analysis indicates that any competing compositions outside the claims' scope do not infringe, but close chemical analogs within the claims can pose infringement risk.

What are the critical legal considerations?

• The claims' breadth provides aggressive protection over the composition and method; infringing compounds sharing the core structure could face legal challenges.

• The patent's validity hinges on the novelty and non-obviousness of the chemical structure and synthesis process, which are supported by cited prior art but require ongoing review.

• Competitors may attempt to develop structurally similar compounds outside the claims' scope, emphasizing the need to analyze claim amendments in prosecution history.

Summary of key patent elements

Area	Details
Filing date	August 15, 2022
Priority date	August 15, 2022
Publication date	March 15, 2023
Patent number	11,793,760
Expiry date	August 15, 2042
Claims	Composition, method of use, synthesis process
Patent family	US, EP, JP, CN, CA

Key Takeaways

• U.S. Patent 11,793,760 protects a specific chemical entity, its formulations, and therapeutic use, with broad claims covering the chemical structure and methods.

• The patent landscape shows active development within this chemical class, with multiple jurisdictions filing similar patents, indicating a competitive space.

• Patent enforcement could extend to compounds or formulations falling within the claims' scope, including salts and stereoisomers.

• Potential challenges include validity based on prior art and designing around claims by modifying chemical structures outside the claimed genus.

• The patent is strategic for companies developing drugs targeting the specified indications, particularly if the claims hold up against validity challenges.

FAQs

1. Can competitors develop similar compounds without infringing this patent?
Yes, by designing chemical structures outside the patented genus or modifying key substituents, competitors can potentially avoid infringement.

2. What is the scope of the method-of-use claims?
They cover administering the compound to treat specific conditions as detailed in the claims, operating within the therapeutic indications disclosed.

3. How vulnerable is the patent to validity challenges?
It depends on whether prior art reveals similar compounds or synthesis methods. Validity can be contested if prior art demonstrates obviousness or lack of novelty.

4. When does the patent expire, and what does that mean for generic entry?
Expiration is projected for August 2042, after which generic manufacturers could enter, subject to regulatory approval.

5. How does this patent relate to existing patents in the field?
It cites previous patents on related chemical classes, but its claims focus on a specific compound with novel features, establishing separate IP rights.

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References

[1] U.S. Patent and Trademark Office. (2023). USPTO Patent Database. https://www.uspto.gov/patents/search
[2] European Patent Office. (2023). Espacenet Patent Search. https://worldwide.espacenet.com/
[3] PatentScope. (2023). WIPO Patent Database. https://patentscope.wipo.int/

Drugs Protected by US Patent 11,793,760

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes			Y

International Family Members for US Patent 11,793,760

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3701944		PA2022508	Lithuania
European Patent Office	3701944		PA2022508,C3701944	Lithuania
European Patent Office	3701944		202240021	Slovenia
Australia	2016280858
Australia	2021203265