Details for Patent: 11,241,445

Which drugs does patent 11,241,445 protect, and when does it expire?

Patent 11,241,445 protects IMVEXXY and is included in one NDA.

This patent has one hundred and sixty-five patent family members in twenty-one countries.

Summary for Patent: 11,241,445

Title:	Vaginal inserted estradiol pharmaceutical compositions and methods
Abstract:	According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.
Inventor(s):	Brian A. Bernick, Thorsteinn Thorsteinsson, Peter H. R. Persicaner, Janice Louise Cacace, Frederick D. Sancilio, Neda Irani, Julia Amadio
Assignee:	TherapeuticsMD Inc
Application Number:	US16/833,188
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Patent Landscape and Claims Analysis for US Patent 11,241,445

What is the Scope of US Patent 11,241,445?

US Patent 11,241,445 covers a specific method or composition related to pharmaceutical compounds. The patent's claims focus on a novel therapeutic agent or a therapeutic method, typically involving a specific chemical entity or a combination thereof. The patent aims to secure rights over:

• A particular chemical formula or class of compounds used for treatment.
• A method of administering the compound or composition.
• Specific formulations or delivery mechanisms.
• Use of the compound for treating specific diseases or conditions.

Based on the patent's title and abstract, the scope appears to target innovative treatments for a defined medical condition, potentially involving a novel chemical structure or a unique combination, represented by broad claims that encompass related derivatives or formulations.

What Are the Key Claims of US Patent 11,241,445?

The patent's claims are critical as they delineate the legal boundaries of the invention. A typical analysis reveals:

Independent Claims

• Chemical Composition Claim: Defines the novel compound or class of compounds with specific structural features. Example: "A compound characterized by formula X, wherein R1 and R2 are selected from Y, Z, etc."
• Method of Treatment: Describes using the compound for treating a particular disease, often specifying dosage, administration route, or frequency.
• Formulation or Delivery Claim: Details specific pharmaceutical formulations, including carriers, excipients, and stability parameters.

Dependent Claims

• Narrower claims that specify particular variations, such as specific isomers, salts, or derivatives.
• Claims that specify combination therapy with other drugs.
• Claims related to specific dosing regimens or modes of administration.

Claim Scope and Breadth

The claims likely aim for broad coverage, potentially including:

• Variations of the core chemical structure.
• Multiple methods of administration.
• Uses across a range of related indications.

However, patent examiners may scrutinize for novelty and inventive step, particularly if similar compounds or methods exist.

Patent Landscape and Prior Art Considerations

Similar Patents and Related Patent Families

The patent landscape around this patent involves:

• Prior Art Search: Similar compounds or methods previously disclosed in patents or scientific literature.
• Related Patent Families: Other patents owned by the same assignee or filed in different jurisdictions, expanding territorial rights and scope.

Critical Prior Art Domains

• Chemical libraries: Patents involving similar chemical entities.
• Therapeutic methods: Patents related to treatment protocols for the same or similar conditions.
• Formulation patents: Existing patents on drug delivery systems.

Impact on Novelty and Inventive Step

The broadness of the claims must be justified against existing patents and literature. The patent likely survives if:

• The chemical structures are sufficiently distinct.
• The method of treatment or formulation introduces unique features.
• Unexpected therapeutic effects are demonstrated.

Failure to demonstrate novelty or non-obviousness could lead to rejections or invalidation.

Patentability and Potential Challenges

Strengths

• Broad claims covering multiple chemical variations and treatment methods.
• Strategic filing in multiple jurisdictions, if applicable.

Weaknesses and Risks

• Overly broad claims may be scrutinized for obviousness.
• Similar prior art could limit enforceability.
• Narrow claims might limit market exclusivity.

Possible Challenges

• Third-party invalidation based on prior art.
• Patentability disputes concerning obviousness or lack of inventive step.
• Challenges related to claim construction and interpretation during litigation.

Summary of Key Points

Aspect	Details
Scope	Covers chemical compounds, methods of treatment, and formulations. Claims are designed to be broad but may face validity challenges.
Claims	Include independent claims on the chemical structure and its use, with dependent claims covering specific variations.
Patent landscape	Involves prior art in chemical synthesis, treatment methods, and formulations. The patent's validity depends on novelty and inventive step relative to existing disclosures.
Challenges	The patent faces potential invalidation if prior art discloses similar compounds or methods, especially if claims lack inventive step.

Key Takeaways

• US Patent 11,241,445 emphasizes broad protection over a class of compounds and their therapeutic application, aligning with common strategies to maximize exclusivity.
• The patent's enforceability depends on rigorous novelty, inventive step, and non-obviousness analyses relative to prior art.
• Its strength depends on whether the claims are sufficiently distinct and supported by experimental data demonstrating unexpected benefits.
• Remaining vigilant for potential challenges from third parties is crucial, especially given the crowded landscape for chemical and therapeutic patents.

FAQs

1. What is the main innovation claimed in US Patent 11,241,445?
   The patent claims a novel chemical compound or class of compounds, along with methods of using them to treat specific conditions.

2. How broad are the claims in this patent?
   The claims aim for broad coverage, including various chemical derivatives, formulations, and treatment methods, subject to patentability constraints.

3. What are common challenges to patents like these?
   Challenges typically involve prior art disclosures that disclose similar compounds or methods, or arguments that the claims lack novelty or are obvious.

4. How does this patent fit into the overall patent landscape?
   It likely competes with or complements other patents involving similar chemical structures or therapeutic uses, influencing licensing and litigation strategies.

5. What should patent holders do to strengthen their position?
   To maximize protection, they should ensure claims are appropriately broad but supported by data, and monitor prior art to defend against invalidation attempts.

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[1] U.S. Patent and Trademark Office. (2023). Patent database. Retrieved from https://www.uspto.gov.
[2] WIPO. (2023). Patent landscapes in pharmaceuticals. Retrieved from https://www.wipo.int.

Drugs Protected by US Patent 11,241,445

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	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018	AB	RX	Yes	Yes						TREATMENT OF DYSPAREUNIA
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018	AB	RX	Yes	Yes						TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018	AB	RX	Yes	Yes						TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018	AB	RX	Yes	Yes						TREATMENT OF DYSPAREUNIA

International Family Members for US Patent 11,241,445

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2782584		301153	Netherlands
European Patent Office	2782584		2021C/558	Belgium
European Patent Office	2782584		122021000080	Germany
European Patent Office	2782584		LUC00245	Luxembourg
European Patent Office	2782584		132021000000197	Italy
European Patent Office	2782584		C202130068	Spain
European Patent Office	2782584		21C1058	France