SECNIDAZOLE - Generic Drug Details

What are the generic sources for secnidazole and what is the scope of patent protection?

Secnidazole is the generic ingredient in one branded drug marketed by Evofem Inc and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Secnidazole has sixteen patent family members in five countries.

There are two drug master file entries for secnidazole. One supplier is listed for this compound.

Summary for SECNIDAZOLE

International Patents:	16
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	7
Patent Applications:	1,096
What excipients (inactive ingredients) are in SECNIDAZOLE?	SECNIDAZOLE excipients list
DailyMed Link:	SECNIDAZOLE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SECNIDAZOLE

Constraining patent/regulatory exclusivity:

10,849,884

Dosage:

GRANULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SECNIDAZOLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Indiana University	Phase 2/Phase 3
Lupin Pharmaceuticals, Inc.	Phase 2/Phase 3
Lupin Research Inc	Phase 3

See all SECNIDAZOLE clinical trials

Pharmacology for SECNIDAZOLE

Drug Class

Nitroimidazole Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for SECNIDAZOLE

P01AB	Nitroimidazole derivatives
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for SECNIDAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	11,000,508		Y
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	11,602,522		Y
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes

International Patents for SECNIDAZOLE

Country	Patent Number	Title	Estimated Expiration
Canada	2959414	SECNIDAZOLE UTILISE DANS LE TRAITEMENT D'UNE VAGINOSE BACTERIENNE (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
Japan	6487534
World Intellectual Property Organization (WIPO)	2016037131

SECNIDAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Secnidazole

Introduction to Secnidazole

Secnidazole, marketed under the brand name Solosec, is a second-generation 5-nitroimidazole antimicrobial agent. It is used to treat bacterial vaginosis and trichomoniasis, and has been approved by the FDA since September 2017[3].

Market Size and Growth Projections

The global market for pharmaceutical-grade secnidazole is experiencing significant growth. As of 2023, the market size was valued at several billion USD and is anticipated to expand substantially by 2031. This growth is driven by increasing demand for effective treatments for bacterial vaginosis and trichomoniasis, as well as the drug's improved pharmacokinetic profile compared to other 5-nitroimidazoles like metronidazole and tinidazole[1].

Segmentation of the Market

The secnidazole market is segmented based on several key factors:

By Type

• Purity ≥ 99%: This segment is expected to dominate the market due to the high demand for pharmaceutical-grade secnidazole.
• Purity < 99%: Although less prevalent, this segment still holds significance in certain applications and regions[1].

By Application

• Tablets: Secnidazole is commonly administered in tablet form, which is the primary application driving market growth.
• Capsules: While less common, capsule formulations also contribute to the market size[1].

By Geography

• North America: A significant market due to high healthcare spending and advanced medical infrastructure.
• Europe: Another major market with a strong pharmaceutical industry.
• Asia-Pacific: Rapidly growing due to increasing healthcare needs and economic development.
• South America and Middle-East & Africa: These regions also contribute to the global market, though to a lesser extent[1].

Market Drivers

Several factors are driving the growth of the secnidazole market:

Increasing Prevalence of Bacterial Vaginosis and Trichomoniasis

The rising incidence of these infections, particularly among women, is a major driver. Secnidazole's effectiveness in treating these conditions makes it a preferred choice[3].

Improved Pharmacokinetics

Secnidazole has a longer terminal elimination half-life and better oral absorption compared to other 5-nitroimidazoles, making it more convenient and effective for patients[3].

FDA Approval and Regulatory Support

The FDA approval in 2017 has been a significant boost to the market, ensuring the drug meets stringent safety and efficacy standards[3].

Market Restraints

Despite the growth, there are several restraints to consider:

Competition from Other Antimicrobials

Other antibiotics and antimicrobials, such as metronidazole and tinidazole, compete with secnidazole in the market. However, secnidazole's superior pharmacokinetic profile helps it maintain a competitive edge[3].

Adverse Effects and Safety Concerns

While generally well-tolerated, secnidazole can cause adverse effects such as nausea, headache, and dizziness. These concerns can impact patient compliance and market growth[3].

Financial Trajectory

Recent Financial Performance

Companies involved in the production and distribution of secnidazole, such as Evofem Biosciences, have shown mixed financial results. For example, Evofem Biosciences reported a 31% improvement in operating loss to $2.4 million in Q3 2024, but also saw a 12% decrease in net product sales to $4.5 million. The acquisition of global rights to Solosec (secnidazole) is expected to diversify revenue streams in the future[2].

Investment and Funding

Investments from other companies, such as Aditxt's $5.0 million investment in Evofem Biosciences since May 2024, indicate confidence in the market potential of secnidazole[2].

Revenue Projections

The market is projected to continue its upward trend, with significant revenue growth anticipated from 2024 to 2031. The CAGR for the secnidazole market is expected to be substantial, driven by increasing demand and expanding geographical reach[1][4].

Competitive Landscape

The competitive landscape of the secnidazole market is characterized by several key players:

Major Companies

• Corden Pharma Bergamo SpA
• Zhejiang Supor Pharmaceuticals
• Dandong Yichuang Pharmaceutical
• Chongqing Lummy LongYu Pharmaceutical
• Renhetang Pharmaceutical
• Hubei Keyi Pharmaceutical
• Hunan Jiudian Pharmaceutical
• Huanggang Saikang Pharmaceutical
• Zhangjiagang Fengda Pharmaceutical
• Hunan Dino Pharmaceutical
• Hainan Zhongyu Pharmaceutical

These companies are profiled based on their product offerings, market presence, and recent developments such as mergers, acquisitions, and new product releases[1].

Market Opportunities

Expanding into New Markets

The acquisition of global rights to Solosec by Evofem Biosciences and the licensing of commercial rights for Phexxi in the Middle East represent significant opportunities for revenue diversification and market expansion[2].

Addressing Unmet Medical Needs

Secnidazole's FDA approval for treating bacterial vaginosis and trichomoniasis addresses a significant unmet medical need, particularly in women's health. This presents a substantial market opportunity[3].

Challenges

Regulatory Hurdles

Navigating regulatory approvals in different regions can be challenging and may impact the market growth of secnidazole.

Competitive Pressure

The presence of other antimicrobials in the market poses a continuous challenge, requiring companies to innovate and differentiate their products.

Key Takeaways

• The secnidazole market is expected to grow significantly from 2024 to 2031, driven by increasing demand and its superior pharmacokinetic profile.
• The market is segmented by type, application, and geography, with North America and Europe being key regions.
• Major drivers include the increasing prevalence of bacterial vaginosis and trichomoniasis, FDA approval, and improved pharmacokinetics.
• Companies like Evofem Biosciences are making strategic moves to expand their market presence and diversify revenue streams.
• Despite challenges, the market presents significant opportunities for addressing unmet medical needs and expanding into new markets.

FAQs

What is secnidazole used for?

Secnidazole is used to treat bacterial vaginosis and trichomoniasis in patients 12 years of age and older[3].

Who are the major players in the secnidazole market?

Major players include Corden Pharma Bergamo SpA, Zhejiang Supor Pharmaceuticals, Dandong Yichuang Pharmaceutical, and others[1].

What are the key drivers of the secnidazole market?

Key drivers include the increasing prevalence of bacterial vaginosis and trichomoniasis, FDA approval, and the drug's improved pharmacokinetic profile[1][3].

How is the competitive landscape of the secnidazole market?

The competitive landscape is characterized by several key players, with companies making strategic moves such as acquisitions and licensing agreements to expand their market presence[1][2].

What are the potential challenges for the secnidazole market?

Challenges include regulatory hurdles, competitive pressure from other antimicrobials, and adverse effects associated with the drug[3].

Sources

1. Market Research Intellect: Global Pharmaceutical Grade Secnidazole Market Size, Scope And Forecast 2021-2031[1].
2. Stock Titan: Evofem Biosciences Announces Financial Results for the Third Quarter of 2024[2].
3. DrugBank: Secnidazole: Uses, Interactions, Mechanism of Action[3].
4. Prof Research: Secnidazole Market Size, Share, Trend and Forecast to 2025[4].