Details for Patent: 11,793,786

Which drugs does patent 11,793,786 protect, and when does it expire?

Patent 11,793,786 protects VALTOCO and is included in one NDA.

This patent has twenty-eight patent family members in eleven countries.

Summary for Patent: 11,793,786

Title:	Administration of benzodiazepine compositions
Abstract:	The invention relates to pharmaceutical compositions comprising one or more benzodiazepine drugs for nasal administration, methods for producing and for using such compositions.
Inventor(s):	Steve Cartt, David Medeiros, Garry Thomas Gwozdz, Andrew Loxley, Mark Mitchnick, David F. Hale, Edward T. Maggio
Assignee:	Neurelis Inc
Application Number:	US17/228,514
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,793,786
Patent Claim Types: see list of patent claims

Understanding the Scope and Claims of United States Patent 11,793,786: A Detailed Analysis

Introduction to Valtoco and Patent 11,793,786

Valtoco, a nasal spray formulation of diazepam, is a critical medication for the treatment of seizure activity in patients with epilepsy. It is developed and commercialized by Neurelis, Inc., a company focused on neuroscience therapeutics. One of the key patents protecting Valtoco is United States Patent 11,793,786, which plays a significant role in the drug's exclusivity and market dominance.

Patent Overview

Patent Number and Expiration Date

• The patent in question is U.S. Patent No. 11,793,786, which was issued on October 24, 2023. It is scheduled to expire on March 27, 2029[2][4][5].

Scope of the Patent

Invention Description

• The '786 patent covers pharmaceutical solutions for nasal administration, specifically those consisting of diazepam or a pharmaceutically acceptable salt thereof. This patent is part of a broader portfolio that includes other Orange Book listed patents, all of which contribute to the exclusivity of Valtoco[2][4].

Claims and Coverage

• The patent claims are directed towards the composition, method of production, and method of use of the nasal spray formulation. It includes specific claims related to the formulation, the process of administering the drug, and the therapeutic effects achieved through this administration. These claims are designed to protect the innovative aspects of Valtoco, ensuring that Neurelis maintains exclusivity over this unique formulation[2][5].

Litigation and Legal Activities

Recent Litigation

• Neurelis has been involved in several legal proceedings to protect the '786 patent. One notable example is the lawsuit against Padagis LLC, Padagis US LLC, and Padagis Israel Pharmaceuticals Ltd. Neurelis alleges that Padagis's submission of an Abbreviated New Drug Application (ANDA) infringes on the '786 patent, along with other asserted patents (U.S. Patent Nos. 8,895,546 and 11,241,414)[2].

Litigation History

• The earliest legal proceeding related to Valtoco's patents was initiated on January 29, 2019, by Aquestive Therapeutics, Inc. (formerly Monosol RX, LLC), challenging the validity of U.S. Patent No. 9,763,876. However, this challenge was terminated and denied in August 2019[1].

Exclusivities and Market Impact

Orange Book Listings

• The '786 patent, along with other patents, is listed in the FDA's Orange Book, which is a publication that lists approved drug products with therapeutic equivalences. These listings are crucial for maintaining exclusivity and preventing the early entry of generic versions of Valtoco[2][4].

Exclusivity Periods

• In addition to patent protection, Valtoco benefits from FDA-granted exclusivities. These exclusivities prevent other companies from marketing a generic or bioequivalent version of Valtoco until they expire, even if the patents themselves are challenged or expire earlier[1].

Clinical and Commercial Significance

Therapeutic Importance

• Valtoco is an immediate treatment for frequent seizure activity in patients with epilepsy aged six years and older. The innovation protected by the '786 patent empowers patients and their care partners to manage their disease more effectively, improving health outcomes[4].

Market Potential

• The issuance of the '786 patent, along with other patents, reinforces the clinical and commercial potential of Valtoco. Neurelis continues to expand its intellectual property portfolio to extend the exclusivity of Valtoco further, which is crucial for the company's commitment to improving patient outcomes[4].

Industry Expert Insights

Neurelis' Perspective

• According to Craig Chambliss, President and Chief Executive Officer of Neurelis, the continued progress with the United States Patent and Trademark Office and the recognition of the inventive nature of Valtoco's franchise are significant milestones. This innovation drives Neurelis' efforts to extend Valtoco's exclusivity and improve patient outcomes[4].

Statistical and Market Context

Patent Landscape

• The patent landscape for pharmaceuticals is complex and highly litigious. For example, patent litigation filings have increased by over 230% over the last 20 years, reflecting the increasing complexity and value of intellectual property in the pharmaceutical sector[3].

Generic Availability

• As of the current date, there is no therapeutically equivalent generic version of Valtoco available in the United States. This is largely due to the robust patent protection and exclusivities in place[5].

Key Takeaways

• Patent Expiration: The '786 patent is set to expire on March 27, 2029.
• Scope and Claims: The patent covers pharmaceutical solutions for nasal administration of diazepam, including composition, production, and use methods.
• Litigation: Neurelis is actively involved in legal proceedings to protect the '786 patent against potential generic challengers.
• Exclusivities: FDA-granted exclusivities, in addition to patent protection, delay the entry of generic versions.
• Clinical Significance: Valtoco is a critical treatment for epilepsy, and the '786 patent protects its innovative formulation.

FAQs

1. What is the expiration date of U.S. Patent No. 11,793,786?

• The patent is scheduled to expire on March 27, 2029[2][4][5].

2. What does the '786 patent cover?

• The patent covers pharmaceutical solutions for nasal administration of diazepam or a pharmaceutically acceptable salt thereof[2][4].

3. Is there a generic version of Valtoco available?

• No, there is currently no therapeutically equivalent generic version of Valtoco available in the United States[5].

4. Why is the '786 patent important for Neurelis?

• The patent is crucial for maintaining the exclusivity of Valtoco, protecting Neurelis' innovative formulation and market position[4].

5. What legal actions has Neurelis taken to protect the '786 patent?

• Neurelis has initiated lawsuits against companies like Padagis LLC to prevent infringement and protect the patent[2].

Sources

1. Pharsight: Valtoco patent expiration.
2. Insight.rpxcorp.com: Complaint - Neurelis v Padagis.
3. Digitalcommons.law.scu.edu: What We Can Learn From Patent Claim Length.
4. PR Newswire: Neurelis Secures New Orange Book Listed U.S. Patent for Valtoco.
5. Drugs.com: Generic Valtoco Availability.

Drugs Protected by US Patent 11,793,786

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No	11,793,786		Y
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020		RX	Yes	No	11,793,786		Y
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes	11,793,786		Y

International Family Members for US Patent 11,793,786

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009228093
Canada	2756690
China	103796656
China	107737100