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 eleven 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:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SECNIDAZOLE
What excipients (inactive ingredients) are in SECNIDAZOLE?	SECNIDAZOLE excipients list
DailyMed Link:	SECNIDAZOLE at DailyMed

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

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
Tulane University	PHASE4
Louisiana State University Health Sciences Center in New Orleans	PHASE4
University of Alabama at Birmingham	PHASE4

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
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes			Y

International Patents for SECNIDAZOLE

Country	Patent Number	Title	Estimated Expiration
Japan	2021042246
Japan	6637624
Japan	2021042246	細菌性膣炎の治療に使用するためのセクニダゾール (SECNIDAZOLE FOR USE IN TREATMENT OF BACTERIAL VAGINOSIS)

Market Dynamics and Financial Trajectory for Secnidazole

Last updated: July 29, 2025

Introduction

Secnidazole is an oral nitroimidazole antibiotic primarily used to treat bacterial vaginosis (BV) and other protozoal infections. As a relatively new entrant in the antimicrobial sphere, its market dynamics are shaped by evolving healthcare needs, competitive landscape, regulatory developments, and broader antimicrobial resistance concerns. Understanding these factors is critical for stakeholders aiming to forecast financial trajectories and formulate strategic decisions within the pharmaceutical space.

Pharmacological Profile and Therapeutic Indications

Secnidazole's unique pharmacokinetics, notably its long half-life allowing a single-dose regimen, provide a significant advantage over traditional therapies for BV, which often require multiple doses. Its efficacy, tolerability, and ease of administration have positioned secnidazole as a preferred option for clinicians and patients alike. Currently approved in the United States for BV in adult women, the drug’s potential to expand into other indications, such as trichomoniasis and protozoal infections, remains under exploration.

Market Drivers

Rising Prevalence of Bacterial Vaginosis

Bacterial vaginosis affects up to 29% of women globally and is associated with adverse reproductive outcomes, including increased susceptibility to sexually transmitted infections (STIs). The high prevalence fuels demand for effective, convenient treatments. Secnidazole's single-dose dosing aligns with patient preference for simplified regimens, promoting adherence and clinical success.

Advancements in Drug Delivery and Convenience

The once-only oral administration enhances patient compliance, positioning secnidazole favorably against traditional multidose therapies like metronidazole. This attribute is especially appealing in primary care and outpatient settings, streamlining therapy and reducing healthcare costs.

Regulatory Approvals and Off-label Opportunities

Secnidazole gained FDA approval in 2017 for BV, setting a regulatory precedent. Expanded approvals and labeling for additional indications are anticipated, contingent on clinical trial outcomes, which could significantly broaden its market footprint.

Competitive Landscape and Market Penetration

While metronidazole and tinidazole dominate current BV treatment, secnidazole offers a differentiated profile. Its pharmacokinetic advantage may secure a niche in treatment guidelines and insurance reimbursements, fostering incremental market share growth.

Antimicrobial Stewardship and Resistance

The shift toward responsible antimicrobial use influences prescribing patterns. The single-dose regimen contributes to stewardship efforts by reducing overtreatment and improving compliance, potentially lowering the risk of resistance development.

Market Challenges

Patent Expiry and Generic Competition

Secnidazole's initial patent protections are nearing expiration, paving the way for generic entrants. Price competition could dilute margins unless the innovator secures new indications or formulations.

Clinical Evidence and Off-label Use Limitations

Limited data on off-label efficacy and safety may restrict broader adoption outside approved indications. Ongoing or future clinical trials to expand indications are critical for sustained growth.

Healthcare Policy and Reimbursement Trends

Evolving healthcare policies emphasizing cost-effectiveness and formulary inclusion influence access and prescribing patterns. Gaining favorable formulary placements is vital for rapid market penetration.

Resistance and Safety Profile Concerns

Although generally well-tolerated, concerns over potential side effects and resistance could impact physician confidence and patient acceptance.

Financial Trajectory

Revenue Projections

Based on current market data, the global BV treatment market alone is expected to surpass USD 1.5 billion annually, with secnidazole constituting a growing fraction due to its advantages. The U.S. market provides the initial revenue base, with expansion into Europe, Asia, and emerging markets contingent on regulatory approvals and clinical evidence.

Growth Strategies

• Pipeline Expansion: Investment in clinical trials for additional indications can unlock new revenue streams.
• Partnerships and Licensing: Collaborations with generic manufacturers post-patent expiry could sustain revenue through royalty arrangements.
• Market Access Efforts: Payer negotiations and clinical education campaigns are pivotal to increasing formulary coverage.

Risks and Revenue Sustainability

Dependence on patent exclusivity, competitive pressure from generics, and potential safety issues pose risks to revenue longevity. Strategic diversification and lifecycle management are vital to maintain financial performance.

Regulatory and Market Outlook

The regulatory landscape remains favorable, with ongoing trials and approvals promising expansion opportunities. The global antimicrobial market is expected to grow at a compounded rate of over 6% annually, driven by rising infection rates and growing awareness. Secnidazole's positioning as a convenient, effective therapy augments its prospects—especially as antimicrobial stewardship policies favor single-dose regimens.

Conclusion

Secnidazole’s market dynamics are characterized by its pharmacokinetic superiority, expanding clinical indications, and strategic positioning against a backdrop of antimicrobial resistance concerns. The drug's financial trajectory hinges on regulatory approvals, competitive responses, and healthcare policy adaptations. With targeted investments in clinical development and market access, secnidazole has the potential to carve a significant share within the antimicrobial and gynecological treatment segments.

Key Takeaways

• Market Growth Potential: The global BV treatment market's expansion, driven by prevalence and management challenges, positions secnidazole as a strategic asset.
• Competitive Differentiation: Its single-dose advantage offers a meaningful differentiator amid traditional therapies, supporting sustained adoption.
• Post-Patent Opportunities: Expiry of patents necessitates diversification strategies, including pipeline expansion and licensing agreements, to mitigate revenue risks.
• Healthcare Policy Impact: Alignment with antimicrobial stewardship initiatives enhances approval and reimbursement prospects.
• Future Outlook: Successful clinical trials for broader indications could significantly augment revenue and market influence.

FAQs

Q1: What are the primary indications for secnidazole?
A: Currently, secnidazole is approved for the treatment of bacterial vaginosis in adult women. Ongoing studies aim to expand its use to other protozoal infections, including trichomoniasis.

Q2: How does secnidazole compare with traditional BV treatments?
A: Its single-dose oral regimen provides superior convenience and adherence compared to multi-dose therapies like metronidazole, potentially leading to better clinical outcomes.

Q3: What are the major market barriers for secnidazole?
A: Patent expiration leading to generic competition, limited indications, and regulatory hurdles for new uses pose significant challenges.

Q4: How does antimicrobial resistance affect secnidazole’s market prospects?
A: Resistance concerns may influence prescribing patterns, but its adherence to stewardship principles and single-dose efficacy confer an advantage in promoting responsible antibiotic use.

Q5: What is the long-term revenue outlook for secnidazole?
A: While initially promising within the BV market, long-term growth depends on expanding indications, maintaining regulatory approval, and navigating competitive pressures post-patent expiry.

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Sources:
[1] Market Research Future, "Global Bacterial Vaginosis Treatment Market," 2022.
[2] U.S. Food and Drug Administration (FDA), "Secnidazole Approval Details," 2017.
[3] GlobalData Healthcare, "Antimicrobial Market Outlook," 2023.