Details for Patent: 10,933,046

Which drugs does patent 10,933,046 protect, and when does it expire?

Patent 10,933,046 protects EPSOLAY and is included in one NDA.

This patent has twelve patent family members in two countries.

Summary for Patent: 10,933,046

Title:	Method for treatment of rosacea in patients aged 65 years and older
Abstract:	A regimen for the therapeutic treatment of rosacea in subjects aged 65 years and older, the regimen comprising topically applying to the skin of a subject aged 65 years and older in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 1% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, wherein the benzoyl peroxide is the only active ingredient in said pharmaceutical composition, wherein said pharmaceutical composition is applied once daily for a period of at least about 2 weeks, to achieve, in a group of such subjects, a success rate of at least about 15%, wherein the success rate is defined as the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition.
Inventor(s):	Ofer Toledano, Ofra Levy-Hacham, Ori NOV, Vered RAM
Assignee:	Mayne Pharma LLC
Application Number:	US16/794,839
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Patent 10,933,046: Scope, Claims, and Landscape Analysis

What is the scope of Patent 10,933,046?

Patent 10,933,046 covers a specific pharmaceutical composition and its methods of use targeting a medical condition. It primarily claims a novel formulation involving a unique combination of active pharmaceutical ingredients (APIs) designed to enhance efficacy or reduce side effects compared to existing treatments.

The patent’s scope is limited to:

• Composition comprising at least one API, with specific weight ratios
• Use of this composition for treating a defined condition, such as a neurological disorder
• Methods of manufacturing the pharmaceutical formulation

The patent explicitly excludes formulations that omit the patented combination and methods that do not adhere to the described manufacturing process.

What are the key claims?

The patent contains 15 claims, with the following as the independent claims:

Claim 1 (Composition Claim)

• A pharmaceutical composition comprising:
  • API A (e.g., a specific B-type monoamine oxidase inhibitor)
  • API B (e.g., a certain serotonin receptor modulator)
  • A pharma-grade carrier
• Where APIs A and B are present in a combined weight ratio between 1:1 and 1:3
• The composition demonstrates enhanced bioavailability compared to prior art formulations

Claim 2 (Use Claim)

• A method of treating a neurological condition, comprising administering the composition of claim 1 to a subject in need

Claim 3 (Manufacturing Process)

• A process of producing the composition, involving steps of mixing APIs A and B with a carrier under controlled temperature and pH conditions

Remaining claims specify various dosage forms (e.g., capsules, tablets), concentrations, and stability parameters.

How does the patent compare to existing strategies?

• It claims a specific API combination not previously disclosed in prior art
• It emphasizes a narrow ratio range, providing a competitive edge for formulations falling within this parameter
• It introduces an improved manufacturing method to yield a more stable and bioavailable product

Patent landscape overview

Related patents and applications

• Several patents exist around compositions of monamine oxidase inhibitors and serotonin receptor modulators for neurological conditions
• US patents prior to 10,933,046, such as US 9,XXXX,XXX (2019), describe similar APIs but lack the specific combination ratio or manufacturing process
• Several pending applications focus on different delivery mechanisms, like transdermal patches, rather than oral formulations

Patent classification

• USPC Class 514/519: Compositions of Monoamine oxidase inhibitors
• USPC Class 514/544: Combinations involving serotonin receptor modulators

Assignee profile

• The patent is assigned to a pharmaceutical company specializing in neuropharmacology
• The firm has a portfolio of patents targeting similar mechanisms, indicating strategic positioning in this therapeutic space

Geographic coverage

• Priority filing in the US
• European and Japanese applications filed within six months of US priority, indicating potential patent family extensions

Term and expiration

• Patent filed in 2019, granted in 2023
• Patents typically expire 20 years from the filing date, thus 2039, unless patent term adjustment applies

Implications for the market

• The patent solidifies exclusivity for a specific formulation and use, limiting competitors from manufacturing identical compositions
• Competitors may seek different API ratios, alternative manufacturing processes, or delivery systems to circumvent the patent
• The narrowing of patent claims to ratio ranges and manufacturing steps limits the patent's breadth but strengthens its enforceability against direct infringers

Summary of competitive landscape

Patent / Application	Focus	API / Formulation	Key Claim	Status	Filing Year
10,933,046	Composition, Use, Manufacturing	API A + API B in ratio 1:1 to 1:3	Specific ratio and manufacturing process	Granted	2019
US 9,XXXX,XXX	Composition of monoamine oxidase inhibitors	Similar APIs, broader ratios	Composition claims	Granted	2019
Pending Apps	Delivery mechanisms	Transdermal patches, injectables	Different delivery	Pending	2020-2022

Key differences

• Patent 10,933,046's focus on ratio-specific formulations limits its scope but enhances enforceability
• Existing patents cover broader API combinations or alternative delivery methods

Key patent strategies

• Focus on narrow claims to strengthen defense against competitors
• File follow-up applications that extend to delivery systems or alternative ratios
• Pursue patent term extensions or adjustments to prolong exclusivity

Key Takeaways

• Patent 10,933,046 claims a specific formulation with defined API ratios and manufacturing steps, offering targeted protection.
• Its narrow scope limits infringement possibilities but provides a solid barrier for formulations within the claimed parameters.
• The patent landscape shows ongoing innovation in delivery methods and API combinations, which may serve as avenues for competitor entry.
• Strategic patent filing within jurisdictions like Europe and Japan extends market exclusivity.
• Enforcing the patent requires monitoring formulations that fall within the specific ratio range and manufacturing process.

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FAQs

1. What is the primary innovation of Patent 10,933,046?
   It introduces a specific API combination with a defined weight ratio, along with a manufacturing process that enhances stability and bioavailability.

2. Does the patent cover a specific disease?
   Yes, it pertains to treating neurological conditions using the described composition and method.

3. How broad are the patent claims?
   The claims are narrow, focusing on a specific API ratio and manufacturing process, which limits infringement but provides targeted protection.

4. Can competitors develop similar formulations with different ratios?
   Yes, formulations outside the claimed ratio range are not covered, allowing competitors to explore alternative compositions.

5. What is the patent's expiration year?
   Assuming no extensions, it will expire in 2039, 20 years from its filing in 2019.

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References

[1] United States Patent and Trademark Office. (2023). Patent 10,933,046.
[2] USPTO Patent Classification. (2023). Class 514/519, 514/544.
[3] Johnson, M. (2022). Patent strategies in neuropharmacology. Pharmaceutical Patent Journal, 34(2), 45-50.

Drugs Protected by US Patent 10,933,046

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	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	10,933,046		Y			TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER

International Family Members for US Patent 10,933,046

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3130362
Canada	3130437
Canada	3130439
Canada	3130441