Details for Patent: 10,774,091

Which drugs does patent 10,774,091 protect, and when does it expire?

Patent 10,774,091 protects LYNKUET and is included in one NDA.

This patent has forty patent family members in thirty-five countries.

Summary for Patent: 10,774,091

Title:	Soft gelatin capsule formulation
Abstract:	The present invention generally relates to novel pharmaceutical formulations containing 2-[3,5-Bis(trifluoromethyl)phenyl]-N-{4-(4-fluoro-2-methylphenyl)-6-[(7S,9aS)-7-(hydroxymethyl)hexahydropyrazino[2,1-c][1,4]oxazin-8(1H)-yl]-3-pyridinyl}-N,2-dimethylpropanamide, methods of preparation thereof and their use in medical therapy.
Inventor(s):	Mike Trower, Monica Lazaro, Derek BUSH, David Elder, Mary Kerr
Assignee:	Kandy Therapeutics Ltd
Application Number:	US16/351,659
Patent Claim Types: see list of patent claims

Analysis of United States Drug Patent 10,774,091: Scope, Claims, and Patent Landscape

United States Patent 10,774,091, titled "CO-FORMULATIONS OF BIFENTHRIN AND AT LEAST ONE OTHER INSECTICIDE," was granted to FMC Corporation on September 15, 2020. The patent covers novel co-formulations of bifenthrin, a pyrethroid insecticide, with at least one other insecticide. These formulations aim to enhance insecticidal efficacy and broaden the spectrum of control against various pest species, particularly in agricultural and professional pest management settings. The invention addresses challenges in pest resistance and the need for integrated pest management (IPM) strategies by providing synergistic or additive insecticidal effects.

What Does United States Patent 10,774,091 Claim?

United States Patent 10,774,091 claims specific co-formulations of bifenthrin with other insecticidal active ingredients, along with methods of using these co-formulations. The claims focus on the composition of matter for these multi-component insecticidal products.

What are the Primary Insecticidal Active Ingredients Covered by the Patent?

The patent explicitly names bifenthrin as a primary active ingredient in its claimed co-formulations. Bifenthrin is a synthetic pyrethroid insecticide known for its broad-spectrum activity and relatively long residual persistence.

What Other Insecticides Can Be Combined with Bifenthrin Under This Patent?

The patent claims combinations of bifenthrin with "at least one other insecticide." While not exhaustive in listing every possible insecticide, the patent provides examples and categories of other insecticides that can be formulated with bifenthrin. These include, but are not limited to:

• Neonicotinoids: Such as imidacloprid, acetamiprid, and thiacloprid.
• Organophosphates: Including chlorpyrifos and malathion.
• Carbamates: Such as carbaryl and propoxur.
• Other Pyrethroids: Such as permethrin and cypermethrin.
• Diamides: Such as chlorantraniliprole and flubendiamide.
• Insect Growth Regulators (IGRs): Such as methoprene and pyriproxyfen.

The specific combination partner is crucial for achieving the claimed synergistic or enhanced effects.

What are the Key Technical Aspects of the Claimed Co-Formulations?

The core of the patent's claims lies in the synergistic or additive insecticidal effects achieved by combining bifenthrin with other active ingredients. The patent describes several embodiments detailing specific ratios and types of co-formulants. The technical advantages sought include:

• Enhanced Efficacy: Achieving higher mortality rates or faster knockdown of pests compared to the individual active ingredients.
• Broadened Spectrum of Control: Targeting a wider range of insect pests, including those that may have developed resistance to certain classes of insecticides.
• Resistance Management: Utilizing combinations that employ different modes of action to delay or overcome pest resistance.
• Improved Residual Activity: Maintaining insecticidal effectiveness over extended periods.
• Formulation Stability and Delivery: Ensuring the physical and chemical stability of the combined active ingredients in various formulation types (e.g., suspension concentrates, emulsifiable concentrates).

What are the Specific Claims of Patent 10,774,091?

United States Patent 10,774,091 contains multiple claims. The most significant are typically the composition of matter claims and method of use claims.

• Claim 1 (Composition of Matter): This claim broadly covers a co-formulation comprising bifenthrin and at least one additional insecticide, along with formulation excipients. It specifies the intended use for controlling arthropods. The claim often defines the percentages or ratios of active ingredients, though specific narrow claims might detail these further.
• Dependent Claims: These claims narrow the scope of the independent claims. For example, they might specify:
  • The identity of the "at least one other insecticide" (e.g., a specific neonicotinoid, diamide).
  • The weight ratio of bifenthrin to the other insecticide.
  • The type of formulation (e.g., liquid suspension, wettable powder).
  • The specific types of pests targeted (e.g., sucking insects, chewing insects).
  • The synergistic or additive effects demonstrated by specific combinations.
• Method Claims: These claims cover the use of the co-formulations. They typically involve applying an effective amount of the co-formulation to a locus where pests are present or are to be controlled. This locus can include agricultural crops, non-crop areas, or structures for structural pest control.

A detailed review of the specific wording of each claim in the patent document is essential for precise legal interpretation. The claims define the legal boundaries of patent protection.

What is the Patent Landscape for Bifenthrin Co-Formulations?

The patent landscape for bifenthrin co-formulations is characterized by extensive intellectual property protection by major agrochemical companies, including FMC Corporation, as well as significant ongoing innovation to address evolving pest pressures and regulatory landscapes.

Who are the Key Players in Bifenthrin Co-Formulation Patents?

FMC Corporation is a primary holder of patents related to bifenthrin co-formulations, as evidenced by patent 10,774,091. Other significant players in the agrochemical industry with substantial patent portfolios that may encompass or overlap with bifenthrin co-formulations include:

• Syngenta: Known for its broad range of crop protection products.
• Bayer AG: A major innovator in pesticides and herbicides.
• BASF SE: Another significant global player in agricultural solutions.
• Corteva Agriscience: Formed from the DowDuPont agricultural divisions, possessing a large IP portfolio.
• Sumitomo Chemical: A Japanese chemical company with agrochemical interests.

These companies frequently file patents on new active ingredient combinations, novel formulations, and specific use patterns to protect their R&D investments.

How Many Patents Cover Bifenthrin Co-Formulations?

While an exact number is fluid due to ongoing filings and expirations, a search of patent databases reveals hundreds of patents and patent applications globally that mention or claim bifenthrin in combination with other active ingredients or in specific formulation types. This indicates a highly active and competitive field. For instance, within the United States Patent and Trademark Office (USPTO) database, searches using keywords like "bifenthrin combination," "bifenthrin co-formulation," and "bifenthrin insecticide mixture" yield numerous results spanning several decades.

What are the Trends in Bifenthrin Co-Formulation Patenting?

Current trends in bifenthrin co-formulation patenting reflect several industry drivers:

• Synergistic Combinations: A strong focus on identifying and patenting combinations that exhibit synergistic insecticidal activity, meaning the combined effect is greater than the sum of individual effects. This allows for lower application rates and improved efficacy.
• Resistance Management Strategies: Patents are increasingly directed towards combinations that employ insecticides with different modes of action to combat growing insect resistance to widely used chemistries.
• New Formulation Technologies: Innovation in formulation science aims to improve the stability, shelf-life, delivery, and user safety of co-formulations, leading to patents on specific delivery systems or inactive ingredient combinations.
• Expanded Pest Spectrum: Patents are sought for combinations that provide control over a broader range of economically important pests, including those that are difficult to manage with single active ingredients.
• Integrated Pest Management (IPM) Compatibility: Research and patenting efforts are also directed towards co-formulations that are compatible with IPM principles, including reduced impact on beneficial insects where possible.

How Does Patent 10,774,091 Fit into the Broader Landscape?

Patent 10,774,091 is part of FMC Corporation's strategy to secure intellectual property rights for its bifenthrin-based products. It specifically protects novel co-formulations that offer enhanced performance. The existence of this patent suggests that FMC has identified specific combinations of bifenthrin with other active ingredients that provide advantageous properties, likely supported by experimental data on efficacy and potentially synergy. This patent contributes to the existing body of knowledge and IP for bifenthrin-based pest control solutions, potentially creating licensing opportunities or competitive barriers for other companies.

The lifespan of this patent, expiring in 2040 (20 years from the filing date of December 22, 2020, assuming the filing date is the priority date for the full term), provides FMC with a significant period to exclusively market and profit from these specific co-formulations. Competitors will need to navigate around its claims or wait for its expiration to introduce non-infringing products or generic versions.

What is the Market Relevance and Strategic Importance of Bifenthrin Co-Formulations?

Bifenthrin co-formulations hold significant market relevance and strategic importance for agrochemical companies due to their ability to address complex pest control challenges and maintain market share in a competitive environment.

How is Bifenthrin Currently Utilized in the Market?

Bifenthrin is a widely used insecticide in agriculture, turf management, and structural pest control. Its broad-spectrum activity against a variety of pests, including mites, ants, termites, and a range of crop pests, makes it a versatile active ingredient. It is formulated as emulsifiable concentrates (EC), suspension concentrates (SC), granules (GR), and other forms.

What are the Primary Target Markets for These Co-Formulations?

The primary target markets for bifenthrin co-formulations include:

• Agriculture: Protecting major crops such as corn, cotton, soybeans, fruits, and vegetables from a wide array of insect and mite pests.
• Professional Pest Management: Used in residential, commercial, and industrial settings for control of structural pests like termites, ants, cockroaches, and nuisance pests.
• Turf and Ornamental: Applied to golf courses, lawns, nurseries, and greenhouses to manage turf-damaging insects and ornamental pests.
• Public Health: In some regions, bifenthrin may be used for vector control programs.

What is the Strategic Importance of Co-Formulations for Companies like FMC?

For companies like FMC Corporation, patenting co-formulations of established active ingredients like bifenthrin is strategically vital for several reasons:

• Extended Product Lifecycles: Co-formulations allow companies to extend the commercial life of successful active ingredients beyond their initial patent expiries by protecting novel combinations.
• Competitive Differentiation: Unique synergistic or additive effects achieved through co-formulation provide a competitive advantage over single-ingredient products or less sophisticated mixtures.
• Addressing Resistance: As pests develop resistance to older chemistries, co-formulations offering multiple modes of action become critical for effective pest management and maintaining product utility.
• Value Addition: Developing enhanced formulations or combinations can command premium pricing and increase profit margins compared to generic or single-active ingredient products.
• Market Leadership: Securing IP in key areas like co-formulations helps companies maintain leadership positions in specific market segments and deter competitors.

What are the Economic Implications of Bifenthrin Co-Formulations?

The economic implications are substantial. The global insecticide market is valued in the tens of billions of dollars annually. Bifenthrin itself is a significant contributor to this market. Co-formulations can increase the market share and revenue potential for bifenthrin-based products by:

• Increasing Market Access: By providing solutions for previously difficult-to-control pest complexes or resistant populations.
• Enhancing Grower/Pest Manager Loyalty: Offering superior performance can foster long-term customer relationships.
• Driving Innovation in R&D: The drive to find new and effective combinations stimulates ongoing research and development, leading to further market growth and product evolution.

The development and protection of co-formulations represent a key strategy for maintaining profitability and market position in the highly competitive agrochemical and pest management industries.

Key Takeaways

• United States Patent 10,774,091, granted to FMC Corporation, protects novel co-formulations of bifenthrin with at least one other insecticide.
• The patent claims aim to achieve synergistic or additive insecticidal effects, broaden the spectrum of pest control, and aid in resistance management.
• Co-formulations are strategically important for extending product lifecycles, differentiating offerings, and addressing pest resistance in the agrochemical market.
• The patent landscape for bifenthrin co-formulations is active and competitive, with multiple major agrochemical companies holding related intellectual property.
• Bifenthrin co-formulations target key markets including agriculture, professional pest management, and turf/ornamental applications.

Frequently Asked Questions

What is the primary benefit of combining bifenthrin with other insecticides as claimed in Patent 10,774,091?

The primary benefit is the potential for synergistic or additive insecticidal effects, leading to enhanced efficacy, a broader spectrum of pest control, and improved resistance management strategies.

When does United States Patent 10,774,091 expire?

Assuming a filing date priority for the full patent term, Patent 10,774,091 is expected to expire in 2040.

Does this patent prevent the use of bifenthrin alone?

No, this patent specifically covers co-formulations of bifenthrin with other insecticides. The use of bifenthrin as a single active ingredient is not directly restricted by this patent, although other patents may cover bifenthrin itself or specific formulations of bifenthrin alone.

Are there any known examples of specific insecticides that are synergistically combined with bifenthrin under this patent?

While the patent broadly claims combinations with "at least one other insecticide," specific dependent claims or the patent specification's examples would detail particular combinations with demonstrated synergistic or additive effects. These often include neonicotinoids, diamides, or other classes of insecticides.

What is the potential impact of this patent on the availability of generic bifenthrin co-formulations?

The patent grants exclusive rights to FMC Corporation for the claimed co-formulations until its expiration. This generally prevents competitors from manufacturing, using, or selling identical or substantially similar co-formulations without a license, thereby limiting the immediate availability of generic versions.

Citations

[1] FMC Corporation. (2020). Co-formulations of bifenthrin and at least one other insecticide (U.S. Patent No. 10,774,091). United States Patent and Trademark Office.

Drugs Protected by US Patent 10,774,091

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Hlthcare	LYNKUET	elinzanetant	CAPSULE;ORAL	219469-001	Oct 24, 2025		RX	Yes	Yes	10,774,091		Y

International Family Members for US Patent 10,774,091

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019233606
Brazil	112020017388
Canada	3092238
Chile	2020002350
China	112292132