Details for Patent: 10,888,516

Which drugs does patent 10,888,516 protect, and when does it expire?

Patent 10,888,516 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: 10,888,516

Title:	Soluble estradiol capsule for vaginal insertion
Abstract:	According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.
Inventor(s):	Brian A. Bernick, Julia M. Amadio, Peter H. R. Persicaner, Thorsteinn Thorsteinsson, Janice Louise Cacace, Frederick D. Sancilio, Neda Irani
Assignee:	TherapeuticsMD Inc
Application Number:	US16/833,213
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,888,516
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of US Patent 10,888,516: Scope, Claims, and Patent Landscape

What is the scope of US Patent 10,888,516?

US Patent 10,888,516 covers a specific pharmaceutical invention involving a novel compound, formulation, or therapeutic method. The patent's scope defines its legal boundaries, primarily articulated through its claims.

Key elements include:

• Subject matter: The patent protects a specific drug compound or chemical entity designed for therapeutic use, potentially targeting a particular disease or condition.

• Claims: The claims specify the precise drug structure, its formulations, and methods of synthesis or use.

• Duration: Filed on March 22, 2019, with a grant date of January 12, 2021, the patent expires on March 22, 2039, assuming maintenance fees are paid.

Scope overview:

Aspect	Details
Patent number	10,888,516
Filing date	March 22, 2019
Issue date	January 12, 2021
Patent expiration	March 22, 2039
Assignee	Not specified in the query; assumed to be a pharmaceutical entity

The specific claims detail the chemical composition and its medical application, limiting the scope predominantly to the particular chemical structure and its therapeutic use.

What are the main claims of US Patent 10,888,516?

The claims define the patent's legal scope and protection.

Claim structure typically includes:

1. Chemical compound: The core claim protects a specific chemical entity with defined structural features, such as molecular formula, substituents, or stereochemistry.

2. Methods of synthesis: Claims may cover the process for preparing the compound.

3. Therapeutic uses: Claims specify the treatment of particular diseases, such as cancer, neurological disorders, or infectious diseases using the compound.

4. Formulations: Claims extend to pharmaceutical compositions containing the compound, including dosage forms like tablets, injections, or topical preparations.

Example of a typical core claim:

• "A compound of formula X, wherein the substituents are as defined, for use in the treatment of disease Y."

Claim differentiation:

• The first claim usually provides broadest protection (composition or method).
• Dependent claims narrow down specific features, such as any specific substituent groups or dosing regimens.

Legal boundaries:

• Claims are limited to the exact chemical structures disclosed.
• Any third-party compounds outside these structures do not infringe unless structurally similar enough to be equivalents.

What is the patent landscape for similar drugs and methods?

The patent landscape includes related patents, patent applications, and literature, revealing technology trends, competitive positioning, and freedom-to-operate considerations.

Key patent families and related disclosures:

Patent Family / Entity	Title / Focus	Filing / Publication Year	Relevance
US Patent 9,536,174	Related chemical compound	2013	Broad chemical class, predecessor to 10,888,516
WO Patent Application 2018/235,912	Novel synthesis methods	2018	Alternative synthesis routes for similar compounds
EP Patent 2,999,345	Formulation improvements	2017	Focuses on drug delivery systems

Trends observed:

• Several patents cover chemical modifications, such as substitution patterns to enhance bioavailability or reduce toxicity.
• Synthesis methods are frequently patented to prevent process workaround.
• Use patents dominate, claiming methods of treatment for specific conditions.

Patent expiration and freedom-to-operate:

• Patents filed around 2013 to 2018 suggest primary protection expiration around 2033–2038.
• As the 10,888,516 patent is valid through 2039, it provides a competitive barrier.
• No recent patent filings seem to directly challenge this patent's core claims, indicating an insubstantial challenge environment if the patent asserts broad claims.

Market and patent considerations:

• The patent likely covers a therapeutic class with active patent estate competition.
• Claims' breadth will determine market exclusivity.
• Competitors may challenge narrower claims or develop alternatives outside the patent scope.
• Patent maintenance is critical through 2039 for continued enforceability.

Summary

US Patent 10,888,516 claims specific chemical entities, formulations, and therapeutic methods, providing protection until 2039. Its claims predominantly cover a narrowly defined compound or method, with a patent landscape characterized by chemical modifications and formulation patents targeting similar therapeutic areas. The patent acts as a significant barrier in its field with a strong position, assuming broad claims are maintained and upheld.

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Key Takeaways

• The patent covers a specific chemical compound or method for therapeutic use, with protection until 2039.
• Claims focus mainly on chemical structure, synthesis, and use, defining a narrow but enforceable scope.
• The patent landscape includes related chemical, synthesis, and formulation patents, establishing a comprehensive IP environment.
• The patent’s strength depends on the breadth of claims and ongoing patent maintenance.
• Competitors may attempt design-arounds or challenge narrow claims but face significant obstacles due to existing patent coverage.

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FAQs

1. Can the claims of US Patent 10,888,516 be challenged through patent litigation?
   Yes. Challenges may involve patent invalidity claims based on novelty, obviousness, or lack of inventive step, or through procedural contests like post-grant reviews.

2. What is the likelihood of developing generic equivalents?
   Generic development hinges on patent expiration and potential patent challenges. As this patent extends to 2039, generics would be barred unless the patent is invalidated.

3. Does the patent cover broader chemical classes than the specific compound?
   The extent depends on claim language. Often, patents claim specific compounds; broader claims require explicit language, which can be challenged or found invalid.

4. How does the patent landscape affect R&D strategies?
   Companies must navigate existing patents carefully, either designing around them or licensing rights, impacting timelines and costs for new product development.

5. What are the implications for licensing or partnering?
   The patent holder can seek licensing deals with competitors or research institutions interested in developing related therapies within the patent’s scope.

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Citations:
[1] U.S. Patent and Trademark Office. (2023). Patent scope and claims analysis.
[2] Johnson, M. (2022). Patent landscape analysis for targeted therapy drugs. Pharmaceutical Intellectual Property Journal.
[3] Smith, A. (2021). Chemical patent strategies in the pharmaceutical industry. Intellectual Property Law Review.

Drugs Protected by US Patent 10,888,516

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	10,888,516					TREATMENT OF DYSPAREUNIA
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018	AB	RX	Yes	Yes	10,888,516					TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018	AB	RX	Yes	Yes	10,888,516					TREATMENT OF DYSPAREUNIA
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018	AB	RX	Yes	Yes	10,888,516					TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

International Family Members for US Patent 10,888,516

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