Details for Patent: 10,335,390

Which drugs does patent 10,335,390 protect, and when does it expire?

Patent 10,335,390 protects SOLOSEC and is included in one NDA.

This patent has sixteen patent family members in five countries.

Summary for Patent: 10,335,390

Title:	Secnidazole for use in the treatment of bacterial vaginosis
Abstract:	Embodiments are directed to a secnidazole formulations and the use of a secnidazole formulation for the treatment of bacterial vaginosis (BV).
Inventor(s):	Pentikis; Helen S. (Timonium, MD), Palling; David (Glen Ridge, NJ), Braun; Carol J. (Ellicott City, MD)
Assignee:	Symbiomix Therapeutics, LLC (Newark, NJ)
Application Number:	14/846,505
Patent Claim Types: see list of patent claims

Understanding the Scope and Claims of United States Patent 10,335,390

Introduction

United States Patent 10,335,390, titled "Secnidazole for use in the treatment of bacterial vaginosis," is a significant patent in the pharmaceutical industry, particularly for the treatment of bacterial vaginosis (BV) and other related conditions. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape.

Patent Overview

Issuance and Assignees The patent was issued on July 2, 2019, to inventors Helen S. Pentikis, David Palling, and Carol J. Braun, and is assigned to Symbiomix Therapeutics, LLC, which is now associated with Evofem Inc.[1][2][4].

Scope of the Patent

Treatment of Bacterial Vaginosis The patent focuses on the use of secnidazole formulations for the treatment of bacterial vaginosis (BV). BV is a common vaginal infection caused by an imbalance of naturally occurring bacterial flora in the vagina. Secnidazole, a nitroimidazole antibiotic, is effective in treating this condition by targeting the anaerobic bacteria responsible for the infection[4].

Claims of the Patent

Formulations and Administration The patent claims cover various aspects of secnidazole formulations, including:

• Dosage Forms: The patent includes claims for different dosage forms such as oral tablets, capsules, and liquids.
• Mode of Administration: It specifies the administration of secnidazole, which is typically oral.
• Ingredient Formulation: The claims detail the specific ingredients and their proportions in the secnidazole formulations.
• Manufacturing Process: The patent also covers the manufacturing processes involved in producing these formulations[1][2][4].

Key Claims

• Claim 1: This claim is directed to a method of treating bacterial vaginosis in a female patient, comprising administering a single oral dose of secnidazole.
• Claim 2: This claim covers a pharmaceutical composition comprising secnidazole and one or more excipients.
• Claim 3: This claim is related to the use of secnidazole for the treatment of BV, specifying the dosage and administration regimen[4].

Patent Expiration Dates

The patent is set to expire on September 4, 2035. This expiration date is consistent across multiple related patents filed by the same inventors and assignees, ensuring that the exclusive rights to the secnidazole formulations for treating BV remain with the patent holders until that date[1][2].

Patent Landscape

Related Patents There are several related patents filed by the same inventors and assignees, all of which are directed to secnidazole formulations and their use in treating bacterial vaginosis and other conditions like trichomoniasis. These patents include:

• US10,682,338
• US10,849,884
• US10,857,133
• US11,000,507
• US11,000,508 All these patents have the same expiration date of September 4, 2035, ensuring a comprehensive protection of the secnidazole formulations[1][2].

Impact on Generic Availability

The presence of these patents and their expiration dates means that there will be no therapeutically equivalent generic version of Solosec (the brand name for secnidazole) available in the United States until after September 4, 2035. This period of exclusivity is crucial for the patent holders as it allows them to recoup their investment in research and development without immediate generic competition[1][2].

Maintenance and Activity

The patent holders have been actively maintaining these patents through the payment of maintenance fees. For example, payments for the 4th year maintenance fees were made in 2023 and 2024 for several of the related patents, ensuring that the patents remain active until their expiration dates[2].

Conclusion on Patent Scope and Claims

United States Patent 10,335,390 is a pivotal patent in the treatment of bacterial vaginosis, offering a single-dose oral treatment option with secnidazole. The scope of the patent is broad, covering various formulations, modes of administration, and manufacturing processes. The patent landscape, including related patents, ensures that the exclusive rights to these formulations are well-protected until September 4, 2035.

Key Takeaways

• Patent Issuance: July 2, 2019
• Assignees: Symbiomix Therapeutics, LLC (now associated with Evofem Inc.)
• Scope: Treatment of bacterial vaginosis with secnidazole formulations
• Claims: Cover dosage forms, mode of administration, ingredient formulation, and manufacturing processes
• Expiration Date: September 4, 2035
• Related Patents: Multiple patents with the same expiration date, ensuring comprehensive protection
• Impact on Generics: No generic version available until after September 4, 2035

FAQs

1. What is the primary use of the secnidazole formulation covered by US Patent 10,335,390? The primary use is for the treatment of bacterial vaginosis (BV).

2. Who are the inventors and assignees of US Patent 10,335,390? The inventors are Helen S. Pentikis, David Palling, and Carol J. Braun. The assignee is Symbiomix Therapeutics, LLC, now associated with Evofem Inc.

3. What is the expiration date of US Patent 10,335,390? The patent is set to expire on September 4, 2035.

4. Are there any related patents to US Patent 10,335,390? Yes, there are several related patents filed by the same inventors and assignees, all of which expire on September 4, 2035.

5. When can generic versions of Solosec be expected? Generic versions of Solosec are not expected until after the patent expiration date of September 4, 2035.

Sources

1. Drugs.com: Generic Solosec Availability.
2. Pharsight: Solosec patent expiration.
3. Google Patents: Secnidazole for use in the treatment of bacterial vaginosis.
4. DrugPatentWatch: Pharmaceutical drugs covered by patent 10,335,390.

Drugs Protected by US Patent 10,335,390

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y			TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y			TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER

International Family Members for US Patent 10,335,390

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015311674
Australia	2018203882
Australia	2018217262
Canada	2959414
Canada	3046521