Details for Patent: 11,000,507

Which drugs does patent 11,000,507 protect, and when does it expire?

Patent 11,000,507 protects SOLOSEC and is included in one NDA.

This patent has sixteen patent family members in five countries.

Summary for Patent: 11,000,507

Title:	Secnidazole for use in the treatment of bacterial vaginosis
Abstract:	Method of treating bacterial vaginosis in a subject in need thereof involving administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules having a volume-weighted particle size distribution within a microgranule population, wherein the volume-weighted particle size distribution as measured from a representative sample of the microgranule population comprises (a) at least 10% of the microgranule population having a volume-weighted particle size about no less than 470 micrometers; or (b) 50% of the microgranule population having a volume-weighted particle size between about no less than 640 micrometers and about no more than 810 micrometers; or (c) 90% of the microgranule population having a volume-weighted particle size about no more than 1170 micrometers; or (d) a combination thereof, which can include some or all of (a) through (c) above.
Inventor(s):	Pentikis; Helen S. (Timonium, MD), Palling; David (Glen Ridge, NJ), Braun; Carol J. (Ellicott City, MD), Holl; Richard (Somerset, NJ)
Assignee:	LUPIN INC. (Baltimore, MD)
Application Number:	16/817,246
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery;

Detailed Analysis of the Scope and Claims of United States Patent 11,000,507

Introduction

United States Patent 11,000,507, titled "Secnidazole for use in the treatment of bacterial vaginosis," is a significant patent in the field of pharmaceuticals, particularly in the treatment of bacterial vaginosis (BV). This patent, issued on May 11, 2021, is assigned to Lupin Inc. and involves the work of inventors Helen S. Pentikis, David Palling, Carol J. Braun, and Richard Holl.

Patent Overview

Inventors and Assignees

The patent was invented by Helen S. Pentikis, David Palling, Carol J. Braun, and Richard Holl, and is assigned to Lupin Inc., a global pharmaceutical company known for its innovative drug formulations[5].

Issue Date and Expiration

The patent was issued on May 11, 2021, and is set to expire on September 4, 2035. This expiration date aligns with several other patents related to secnidazole formulations for treating BV[5].

Scope of the Patent

Treatment of Bacterial Vaginosis

The primary focus of this patent is the use of secnidazole, a nitroimidazole antibiotic, in the treatment of bacterial vaginosis. BV is a common vaginal infection caused by an imbalance of the natural bacterial flora in the vagina. Secnidazole has been shown to be effective in treating this condition by targeting the anaerobic bacteria responsible for the infection[1][4].

Formulations and Administration

The patent covers various formulations of secnidazole, including oral tablets, granules, and other forms designed to enhance the drug's efficacy and patient compliance. The specific formulations mentioned include microgranule formulations, which are designed to improve the bioavailability and stability of the drug[1][5].

Claims of the Patent

Therapeutically Effective Amounts

The patent claims involve the administration of therapeutically effective amounts of secnidazole to subjects in need of treatment for bacterial vaginosis. This includes specific dosages and regimens that have been clinically validated to treat BV effectively[1].

Method of Treatment

The method of treatment claimed in the patent involves administering secnidazole in a manner that ensures optimal therapeutic outcomes. This includes the timing, dosage, and form of the drug, all of which are critical in achieving the desired clinical results[1].

Pharmaceutical Compositions

The patent also claims various pharmaceutical compositions that contain secnidazole as the active ingredient. These compositions may include excipients, inactive ingredients, and other components that enhance the stability, bioavailability, and patient acceptability of the drug[5].

Patent Landscape

Multiple Patents and Exclusivities

Secnidazole, marketed under the brand name Solosec by Evofem Inc., is protected by a series of patents filed between 2019 and 2023. These patents cover different aspects of the drug, including its use in treating BV, trichomoniasis, and other sexually transmitted infections. None of these patents have expired yet, with the earliest expiration dates set for September 4, 2035[2][5].

Patent Expiration and Generic Launch

The patent landscape indicates that the generic launch of secnidazole is estimated to be around September 16, 2035, based on the expiration of the current patents and exclusivities. This timeline suggests that the market will remain protected for the branded version of secnidazole until then[2].

Challenges and Litigation

The patents related to secnidazole will be open to challenges from September 15, 2026. This period allows for potential legal disputes and challenges to the patent claims, which could impact the exclusivity period and the timing of generic entries into the market[2].

Impact on the Pharmaceutical Industry

Innovation and Competition

The robust patent protection for secnidazole formulations ensures that Lupin Inc. and other assignees maintain a competitive edge in the market for treating BV. This protection incentivizes further innovation in drug formulations and delivery systems, as companies seek to develop new and improved treatments within the scope of existing patents[3].

Patient Access and Compliance

The specific formulations and administration methods covered by the patent can enhance patient compliance and access to effective treatments. By ensuring that the drug is available in forms that are easy to administer and have high bioavailability, the patent contributes to better health outcomes for patients with BV[1][4].

Key Takeaways

• Secnidazole Efficacy: The patent highlights the efficacy of secnidazole in treating bacterial vaginosis.
• Formulations and Administration: Various formulations, including microgranule formulations, are covered to enhance bioavailability and patient compliance.
• Patent Protection: The patent is part of a series protecting secnidazole until September 4, 2035.
• Generic Launch: The generic launch is estimated for September 16, 2035.
• Innovation and Competition: The patent protection incentivizes innovation and maintains competitive advantage.

FAQs

Q: What is the primary use of secnidazole as described in the patent? A: The primary use of secnidazole as described in the patent is for the treatment of bacterial vaginosis.

Q: Who are the inventors of the patent? A: The inventors of the patent are Helen S. Pentikis, David Palling, Carol J. Braun, and Richard Holl.

Q: When does the patent expire? A: The patent is set to expire on September 4, 2035.

Q: What types of formulations are covered by the patent? A: The patent covers various formulations including oral tablets, granules, and microgranule formulations.

Q: How does the patent impact the pharmaceutical industry? A: The patent protects the exclusivity of secnidazole formulations, incentivizing innovation and maintaining a competitive edge in the market for treating BV.

Sources

1. US11000507B2 - Secnidazole for use in the treatment of bacterial vaginosis - Google Patents
2. Solosec patent expiration - Pharsight
3. Patent Claims and Patent Scope - Search eLibrary :: SSRN
4. Secnidazole: Uses, Interactions, Mechanism of Action - DrugBank
5. Generic Solosec Availability - Drugs.com

Drugs Protected by US Patent 11,000,507

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 TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
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
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y			TREATMENT OF TRICHOMONIASIS IN ADULTS
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y			TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN

International Family Members for US Patent 11,000,507

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015311674
Australia	2018203882
Australia	2018217262
Canada	2959414
Canada	3046521
Japan	2017526697