Details for Patent: 10,836,768

Which drugs does patent 10,836,768 protect, and when does it expire?

Patent 10,836,768 protects VEOZAH and is included in one NDA.

This patent has forty patent family members in twenty-nine countries.

Summary for Patent: 10,836,768

Title:	N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists
Abstract:	A method for treating and/or preventing polycystic ovary syndrome (PCOS) including the administration, to a patient in need thereof, of a pharmaceutically effective amount of a compound of Formula I
Inventor(s):	Hoveyda Hamid, Dutheuil Guillaume, Fraser Graeme
Assignee:	Ogeda SA
Application Number:	US16204390
Patent Claim Types: see list of patent claims

Understanding the Scope and Claims of United States Patent 10,836,768

Introduction

United States Patent 10,836,768, titled "N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists," is a significant patent in the pharmaceutical industry, particularly in the development of treatments for various medical conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

The patent, assigned to the owner of Veozah, a drug that targets NK-3 receptors, describes a method for treating and/or preventing conditions such as polycystic ovary syndrome (PCOS), hot flashes, and other diseases mediated by NK-3 receptors[4].

Claims

The patent includes several claims that define the scope of the invention:

Independent Claims

• The patent claims cover specific chemical compounds, namely N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines, which act as selective NK-3 receptor antagonists.
• These claims specify the structure and substitution patterns of the compounds, ensuring that only these particular compounds are protected under the patent[4].

Dependent Claims

• Dependent claims further narrow down the scope by specifying particular substituents, methods of administration, and specific diseases that these compounds can treat.
• For example, claims may specify the use of these compounds in treating hot flashes, breast cancer, prostate cancer, and other inflammatory diseases[4].

Patent Scope

The scope of the patent is defined by the language and breadth of its claims.

Independent Claim Length and Count

Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Longer and more numerous independent claims generally indicate a broader patent scope. In this case, the patent includes detailed descriptions of the chemical compounds and their therapeutic uses, indicating a well-defined but specific scope[3].

Chemical Class and Substances

The patent protects compounds within the chemical class of pyrazines, specifically those with the [1,2,4]triazolo[4,3-a]pyrazine structure. This specificity limits the scope to a particular class of compounds, preventing other companies from developing similar drugs until the patent expires[4].

Patent Landscape

Understanding the broader patent landscape is crucial for strategizing market entry and generic drug development.

Exclusivities and Patent Expiration

• The patent is protected by multiple exclusivities, including a New Chemical Entity Exclusivity (NCE) that expires on May 12, 2028. This exclusivity prevents the launch of generic versions of Veozah until its expiration, regardless of the patent status[1].
• The underlying patents, such as US9422299 and US8871761, are set to expire in 2034 and 2031, respectively. These expiration dates are critical for planning generic launches[1].

Family Patents

• Veozah is protected by a family of patents in multiple countries, which complicates the generic launch landscape. Identifying markets with weaker patent protection can be a strategy for early generic entry[1].

Ongoing Legal Activities

• Recent legal activities, such as the payment of maintenance fees and letters to regulatory agencies regarding Patent Term Extensions (PTE), can affect the patent's expiration date. Tracking these activities is essential for predicting the generic launch timeline[1].

Impact on Generic Launch

The patent and exclusivity landscape significantly impact the timing and feasibility of generic drug launches.

Delayed Generic Entry

• The exclusivity period and patent expiration dates delay the entry of generic versions of Veozah. Companies must wait until these protections expire before they can develop and market generic equivalents[1].

Strategic Market Entry

• Understanding the patent landscape allows companies to identify potential markets where the patent protection is weaker or has expired, enabling strategic market entry for generic drugs[1].

Conclusion

United States Patent 10,836,768 is a critical component of the intellectual property portfolio for Veozah, protecting specific chemical compounds and their therapeutic uses. The patent's scope, defined by its claims and exclusivities, plays a significant role in delaying generic drug launches. Companies seeking to enter the market with generic versions must carefully monitor the patent landscape and exclusivity periods.

Key Takeaways

• Patent Scope: Defined by specific chemical compounds and therapeutic uses.
• Claims: Include independent and dependent claims specifying the structure and use of the compounds.
• Exclusivities: New Chemical Entity Exclusivity expires on May 12, 2028, delaying generic launches.
• Patent Expiration: Underlying patents expire between 2031 and 2034.
• Family Patents: Protection in multiple countries complicates generic launch strategies.
• Legal Activities: Ongoing activities can affect patent expiration dates.

FAQs

1. What is the main subject of United States Patent 10,836,768?

   • The patent covers N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists.

2. When does the New Chemical Entity Exclusivity for Veozah expire?

   • The NCE exclusivity expires on May 12, 2028.

3. What are the key factors delaying the generic launch of Veozah?

   • The exclusivity period and the expiration dates of the underlying patents are the primary factors.

4. How does the patent landscape affect generic drug development?

   • The patent landscape, including exclusivities and patent expirations, determines when and where generic drugs can be launched.

5. What is the significance of tracking ongoing legal activities on Veozah's patents?

   • Tracking these activities helps predict changes in the patent expiration dates and generic launch timelines.

Sources

1. Pharsight: Veozah patent expiration.
2. USPTO: Patent Claims Research Dataset.
3. Hoover Institution: Patent Claims and Patent Scope.
4. Google Patents: US10836768B2 - N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists.
5. ACUS: U.S. Patent Small Claims Court.

Drugs Protected by US Patent 10,836,768

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes						TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE WITH MENOPAUSE

International Family Members for US Patent 10,836,768

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2948455		301272	Netherlands
European Patent Office	2948455		CA 2024 00017	Denmark
European Patent Office	2948455		CR 2024 00017	Denmark
European Patent Office	2948455		PA2024513	Lithuania
European Patent Office	2948455		LUC00342	Luxembourg
European Patent Office	2948455		2024C/523	Belgium