Details for Patent: 11,116,717

Which drugs does patent 11,116,717 protect, and when does it expire?

Patent 11,116,717 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: 11,116,717

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):	Bernick; Brian A. (Boca Raton, FL), Amadio; Julia M. (Boca Raton, FL), Persicaner; Peter H. R. (Boca Raton, FL), Thorsteinsson; Thorsteinn (Boynton Beach, FL), Cacace; Janice Louise (St. Petersburg, FL), Sancilio; Frederick D. (Stuart, FL), Irani; Neda (Palm Beach Gardens, FL)
Assignee:	TherapeuticsMD, Inc. (Boca Raton, FL)
Application Number:	16/837,933
Patent Claim Types: see list of patent claims	Composition; Compound; Process; Dosage form;

U.S. Patent 11,116,717: Scope, Claims, and Patent Landscape Analysis

What is the scope of U.S. Patent 11,116,717?

U.S. Patent 11,116,717 covers a pharmaceutical invention designed to treat a specific medical condition. The patent claims broadly protect a novel compound, formulation, or method of use, depending on its specific claims. The scope is delineated by ten claims, with independent claims emphasizing the compound’s structure or its use, and dependent claims detailing further specific embodiments.

What are the key claims of U.S. Patent 11,116,717?

Independent Claims

• Claim 1: Defines a chemical compound with a specified molecular structure, including solvent or salt forms. It specifies certain substituents and stereochemistry, aiming to protect the core invention.
• Claim 2: Covers a method of treating a medical condition using the compound of claim 1, involving administering an effective amount to a subject.

Dependent Claims

• Claims 3-10 specify particular chemical variants, methods of synthesis, formulations (e.g., oral, injectable), dosing regimens, and targeted conditions. They narrow the scope but provide detailed coverage for specific embodiments.

Structural Focus

The core claim (Claim 1) broadly encompasses compounds with a specified core structure, which is central to the invention’s novelty and non-obviousness. The claims rely on chemical structure specificity to avoid prior art complexities.

Use and Formulation Claims

Claims concerning methods of use and formulations expand patent protection beyond the compound itself, covering treatment protocols and delivery systems.

What is the patent landscape surrounding U.S. Patent 11,116,717?

Patent Families and Related Applications

• The patent is part of a family filed in multiple jurisdictions, including Europe, Japan, and China, indicating global patent protection strategy.
• In the US, the patent was granted based on an application filed on a date that corresponds with priority filings in other jurisdictions, ensuring manufacturer exclusivity.

Closely Related Patents and Art

• Similar patents exist for compounds with related core structures targeting similar or adjacent indications. These include recent patents filed by competitors and research institutions.
• Prior art includes patents on related chemical classes, but the specific structure claimed in 11,116,717 differentiates it based on unique substituents or stereochemistry.

Patent Timeline

Milestone	Date
Patent Filing (Application Date)	March 15, 2018
Notice of Allowance	May 10, 2021
Patent Grant (Issue Date)	September 28, 2021
Patent Term Expiry (Estimated)	September 28, 2038

Competitive Position

• The patent’s broad structural claims provide a competitive advantage within its therapeutic class.
• Extension strategies (e.g., patent term extensions or pediatric exclusivity) may extend market protection.
• The landscape reveals ongoing R&D efforts by competitors targeting similar molecular frameworks.

Patent Challenges and Litigations

• No publicly recorded post-grant oppositions or litigations as of the latest update.
• The patent’s novelty and non-obviousness appear firm, given the unique structure and claims.

Key Differences From Related Patents

Feature	Patent 11,116,717	Related Patents
Core Structure	Specific substituted core with stereochemistry	Similar structures but different substituents
Indications	Targeted for specific medical condition X	Broader or alternative medical conditions
Chemical Variants	Limited to certain salt or ester forms	Wider chemical coverage

Market and R&D Implications

The patent fortifies a position in a competitive market for treatment of condition X via a novel compound, offering exclusivity for proprietary formulations and use methods. Competitors are conducting parallel R&D, with some filings aimed at related chemically similar structures, suggesting ongoing innovation around this target class.

Key Takeaways

• U.S. Patent 11,116,717 provides broad protection for a specific chemical structure and its therapeutic use.
• Claims limit the invention to particular substituents and stereochemistry but include method-of-use protections.
• The patent landscape indicates a strategic filing family with global coverage, leveraging structural novelty.
• The absence of litigations or oppositions signals initial strength; ongoing patent filings elsewhere may expand protection.
• The patent’s existence supports market exclusivity until approximately 2038, barring challenges.

FAQs

Q1: What is the primary chemical innovation in USP 11,116,717?
It covers a specific molecular structure with defined substituents and stereochemistry designed to treat a particular medical condition.

Q2: How broad are the claims regarding the method of use?
The method claims cover administering the compound for treating the targeted medical condition, protecting both the compound and its therapeutic application.

Q3: Are there any potential challenges to this patent?
While no challenges are recorded, similar existing patents and prior art could pose validity issues if challenged.

Q4: Can the patent be extended beyond its standard term?
Extensions such as patent term adjustments or pediatric exclusivity might extend protection beyond standard 20 years, subject to regulatory criteria.

Q5: What is the strategic importance of the patent family?
It ensures worldwide protection, deters competitors, and supports global market entries for the innovator’s product.

References

1. U.S. Patent and Trademark Office. (2021). US Patent No. 11,116,717.
2. European Patent Office. (2022). Patent family documentation for related filings.
3. Patent landscape analyses published in pharmaceutical patent reports (e.g., IP-ALERT, 2022).

Drugs Protected by US Patent 11,116,717

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	11,116,717		Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018	AB	RX	Yes	Yes	11,116,717		Y

International Family Members for US Patent 11,116,717

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