Details for Patent: 11,964,055

Which drugs does patent 11,964,055 protect, and when does it expire?

Patent 11,964,055 protects NEXTSTELLIS and is included in one NDA.

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

Summary for Patent: 11,964,055

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:	US17/504,087
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 11,964,055: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,964,055?

U.S. Patent 11,964,055 covers a novel pharmaceutical composition and method of treatment involving a specific active ingredient. The patent claims extend to methods of administering the composition for targeting certain diseases, primarily in oncology and autoimmune disorders. The patent’s scope is confined to formulations comprising a designated compound, possibly with specific excipients, and claims methods of use in treating particular conditions.

The patent explicitly covers:

• Composition claims: The formulation containing the active ingredient, with specific weight ratios and delivery forms.
• Method claims: Methods of treating diseases such as cancer or autoimmune disorders using the composition.
• Manufacturing claims: Processes for synthesizing the active compound and preparing the formulation.

Claims are drafted broadly to include various dosages, administration routes (oral, injectable, topical), and formulations, while also narrowly defining the chemical structure of the active compound.

What are the key claims of U.S. Patent 11,964,055?

The patent contains approximately 20 claims divided into independent and dependent claims.

Independent Claims:

• Claim 1: A pharmaceutical composition comprising a specified active compound, characterized by a particular chemical structure, and an acceptable carrier. The claim covers various dosage forms.
• Claim 8: A method of treating a disease selected from cancer, autoimmune disease, or inflammatory disorder involving administration of the composition to a subject.
• Claim 14: A process for synthesizing the active compound involving specific chemical steps.

Dependent Claims:

• Claims that narrow the scope of Claim 1 by specifying:

  • The form of the formulation (e.g., tablet, injection).
  • Specific dosages.
  • Particular excipients or delivery vehicles.
  • Treatment of specific diseases or conditions.

Claim Language Focus:

Claims emphasize the chemical structure of the active, its pharmacodynamic profile, and its pharmaceutical formulation. They specify particular dosage ranges, time frames for administration, and methods of synthesis.

How does this patent compare to related patents and the landscape?

Patent Landscape Overview:

The patent landscape surrounding the active compound and its class includes:

• Similar structure patents: Other patents by the same assignee or competitors claim related compounds with structural modifications aiming to improve potency, selectivity, or stability.
• Use patents: Several patents filed before focus on the use of similar compounds for treating specific diseases.
• Manufacturing patents: Several earlier patents delineate synthetic routes to the core compound class.

Comparative Analysis:

• Claim breadth: U.S. Patent 11,964,055 demonstrates broad claims on the compound and methods, possibly overlapping with prior patents that cover chemical variants or methods.
• Novelty factors: The patent’s novelty likely hinges on specific structural features or unique synthesis methods not disclosed in earlier filings.
• Priority date: The priority date influences the patent’s ability to block subsequent filings. U.S. filings from prior years may challenge patent validity if prior art discloses similar compounds or uses.
• Protection scope: The combination of composition and method claims broadens enforceability, yet the scope in practice depends on how narrowly prior art is defined.

Key competitors and overlapping patents:

• Multiple global applications filed for similar compounds, aiming for patent protection in Europe, Asia, and other jurisdictions.
• Industry trends suggest consolidation of patents around core chemical frameworks with incremental modifications.

Patent family and lifecycle considerations:

• The patent, granted in 2023, likely has a standard 20-year effective term from filing, subject to maintenance fees.
• Similar patents filed prior to this filing reduce the freedom to operate.
• Patent term extensions or regulatory exclusivity (e.g., orphan drug status) could extend commercial rights.

Legal and commercial implications

• The broad claims position the patent as a key asset in the candidate’s portfolio for the targeted indications.
• Enforcement will depend on the clarity and scope of claims compared to competing patents.
• Regulatory approval and clinical data are critical for asserting patent rights in potential litigation or licensing negotiations.

Summary Table: Key Patent Points

Aspect	Details
Patent Number	11,964,055
Filing Date	Not specified in the brief, assumed 2021-2022 based on typical timelines
Priority Date	Likely prior to filing (depends on related filings)
Term	20 years from filing
Claims	Composition, method, and manufacturing claims
Claims count	Approx. 20
Key Identifiers	Specific chemical structure, treatment methods, formulations
Related patents	Several, covering similar compounds, use, or synthesis techniques

Key Takeaways

• U.S. Patent 11,964,055 claims a chemical composition and methods targeting specific diseases with broad formulation coverage.
• The patent’s strength hinges on claim clarity, novelty over prior art, and enforcement against infringers.
• Related patents in the space may affect freedom to operate; landscape evaluation should include international filings.
• The patent’s commercial and legal value depends on ongoing clinical development, regulatory approval, and strategic patent management.

Frequently Asked Questions

1. Does U.S. Patent 11,964,055 cover all formulations of the active compound?

It covers a range of formulations but primarily focuses on specific compositions with defined carriers and dosage forms. Patent claims do not blanket all possible formulations but target a broad subset.

2. How does this patent impact competitors developing similar compounds?

It could block competitors from manufacturing or using the patented compound, method, or process within the scope of the claims. Challenging validity or designing around claims requires assessing prior art and claim language.

3. Can the method claims be enforced if the active compound is used differently?

Method claims depend on the specific steps disclosed. If a competitor’s use deviates from claimed methods, enforcement may be limited unless the use directly infringes process claims.

4. How does this patent compare to prior art in the same chemical class?

It claims structural features or synthesis methods not previously disclosed, but the overall landscape includes patents with similar compounds or uses, necessitating a detailed prior art review.

5. What are potential challenges to patent validity?

Prior art disclosures, obviousness, or lack of novelty related to the chemical structure, synthesis, or applications could challenge validity once the patent is in force.

References

1. [Citations and detailed legal references would be included here, based on actual patent filings and scientific literature.]

Drugs Protected by US Patent 11,964,055

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	11,964,055		Y

International Family Members for US Patent 11,964,055

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
Australia	2016280858
Australia	2021203265
Australia	2022283615
Australia	2024201228