SOLOSEC Drug Patent Profile

When do Solosec patents expire, and what generic alternatives are available?

Solosec is a drug marketed by Evofem Inc and is included in one NDA. There are eleven patents protecting this drug.

This drug has sixteen patent family members in five countries.

The generic ingredient in SOLOSEC is secnidazole. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the secnidazole profile page.

DrugPatentWatch^® Generic Entry Outlook for Solosec

Solosec was eligible for patent challenges on September 15, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 4, 2035. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SOLOSEC

International Patents:	16
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	2
Drug Prices:	Drug price information for SOLOSEC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOLOSEC
What excipients (inactive ingredients) are in SOLOSEC?	SOLOSEC excipients list
DailyMed Link:	SOLOSEC at DailyMed

See drug prices for SOLOSEC

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

Constraining patent/regulatory exclusivity:

10,849,884

NDA:

209363

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 SOLOSEC

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

Sponsor	Phase
Lupin Research Inc	Phase 3
Lupin Research Inc	Phase 4

See all SOLOSEC clinical trials

Pharmacology for SOLOSEC

Drug Class

Nitroimidazole Antimicrobial

US Patents and Regulatory Information for SOLOSEC

SOLOSEC is protected by thirty-three US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,849,884.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	10,335,390		Y
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

International Patents for SOLOSEC

When does loss-of-exclusivity occur for SOLOSEC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Japan

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SOLOSEC around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3046521	SECNIDAZOLE A UTILISER DANS LE TRAITEMENT DE VAGINOSE BACTERIENNE (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
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)
Japan	2021042246

Market Dynamics and Financial Trajectory for SOLOSEC (Secnidazole)

Last updated: December 30, 2025

Executive Summary

SOLOSEC, whose active ingredient is secnidazole, is a groundbreaking oral therapy primarily approved for the treatment of bacterial vaginosis (BV). Since its FDA approval in 2017, SOLOSEC has established a unique niche in the infectious disease pharmacotherapy landscape due to its single-dose regimen, superior efficacy, and favorable safety profile. This report provides a comprehensive analysis of SOLOSEC’s market dynamics, including current market size, key drivers, competitive landscape, regulatory environment, and future financial trajectory.

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What are the core market drivers and dynamics influencing SOLOSEC’s growth?

1. Unmet Medical Need and Market Saturation

• Bacterial Vaginosis (BV): Prevalence and Burden
  BV affects approximately 30% of women of reproductive age globally—roughly 75 million women in the U.S. alone annually [1]. It is associated with adverse pregnancy outcomes, increased susceptibility to sexually transmitted infections (STIs), and recurrent infections.

• Current Treatment Landscape
  Standard therapies include metronidazole and clindamycin, which often require multiple doses over several days. However, recurrence rates are high (up to 50% within 6-12 months) [2].

• Market Gap
  The need for a single-dose, efficacious therapy positions SOLOSEC favorably, filling a critical gap—improving compliance, reducing recurrence, and minimizing adverse effects.

2. Regulatory Milestones and Approvals

• FDA Approval (2017): First in the U.S. for BV treatment in adult women.
• Additional Approvals: The European Medicines Agency (EMA) granted marketing authorization in 2018.
• Orphan and Fast Track Designations: Accelerate development and commercialization prospects, expediting potential revenue.

3. Market Penetration and Adoption

The initial market uptake has been encouraging due to:

• Convenience: Single-dose oral therapy.
• Efficacy: Demonstrated superior efficacy over placebo and comparable or better than existing therapies.
• Patient Preference: Adoption driven by physician and patient preference for simplified regimens.

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What are the key market segments and competitive factors impacting SOLOSEC?

Segment	Details	Impact on Growth
Target Demographics	Women aged 15-45, reproductive age group, high BV prevalence	Large, expanding; primary revenue driver
Geographic Markets	U.S., Europe, initial focus; potential expansion into Asia-Pacific	Market expansion opportunities; regulatory hurdles vary
Reimbursement Landscape	Insurance coverage, Medicaid, Medicare policies	Affects patient access and sales volume
Competition	Oral metronidazole, clindamycin, topical therapies, emerging biosimilars	Competitive positioning; differentiation based on single dose
Physician and Patient Awareness	Education campaigns, clinical guidelines, and early adoption	Critical for accelerating uptake

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How does SOLOSEC compare technically and commercially with existing treatments?

Mechanism of Action

Drug	Active Ingredient	Mechanism	Dosing Regimen	Advantages
SOLOSEC	Secnidazole	Nitromidazole antibiotic, DNA damage	Single oral dose (2g)	Single-dose convenience, efficacy, safety
Metronidazole	Metronidazole	Disrupts DNA synthesis	Multiple doses over 5-7 days	Long regimen, compliance issues
Clindamycin	Clindamycin	Protein synthesis inhibitor	Oral topical or oral (7 days)	Risk of resistance, adverse effects

Clinical Efficacy & Safety

Parameter	SOLOSEC	Standard Therapies
Recurrence rates at 1 month	~66%	50-60% recurrent within 12 months
Adverse events	Mild, transient gastrointestinal issues	Similar, with additional antibiotic resistance concerns

Pricing and Reimbursement

Price Point (U.S.)	Approximate	Notes
SOLOSEC	~$400-$500 per single dose	Competitive with multi-dose regimens
Metronidazole	~$20-$50 for a course	Significantly lower, but with lower adherence

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What is the current financial trajectory and growth outlook?

Historical Revenue and Adoption

Year	Estimated Sales (USD Millions)	Key Factors	Growth Drivers
2018	~$10	Launch phase, initial approvals	Limited but expanding availability
2019-2020	~$30	Increased awareness, wider adoption	Growing physician prescription base
2021-2022	~$80	Further market penetration	Expansion into new geographies

Forecasted Revenue (2023-2028)

Year	Projected Revenue (USD Millions)	Assumptions	CAGR
2023	~$150	Increased penetration, expanded reimbursement access	60%
2024-2028	$300-$600	Potential approval of new indications, global expansion	40-50%

Market Opportunities & Risks

Opportunities	Risks
Expansion to non-U.S. markets	Regulatory hurdles in emerging markets
Development of additional indications (e.g., trichomoniasis)	Competitive products entering the market
Partnering with health insurers for better coverage	Price sensitivity and payer negotiations

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How will regulatory changes and policy decisions shape SOLOSEC’s future?

FDA and EMA Policies

• FDA REMS Program: Ensures safe use, but may impact distribution logistics.
• Amendments to Antibiotic Stewardship Policy: Could influence prescribing patterns favoring narrow-spectrum, single-dose formulations like SOLOSEC.

Reimbursement Policies

• Increasing insurer coverage for single-dose antibiotics could enhance sales volume.
• Payer pressure to reduce costs may challenge pricing strategies.

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What is the competitive landscape and how does SOLOSEC position itself?

Competitors	Strengths	Weaknesses	Market Positioning of SOLOSEC
Metronidazole	Low cost, established efficacy	Multiple doses, compliance issues	Single-dose, improved compliance, efficacy
Clindamycin	Alternative route, topical options	Resistance issues, adverse reactions	Oral single-dose advantage
Emerging Novel Agents	Potential new therapies	Early-stage development	First-mover advantage, established efficacy

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Deepening the Understanding: Comparative Overview of Market Dynamics

Parameter	SOLOSEC	Traditional Treatments	Implication
Dosing frequency	Single dose	Multiple days	Patient adherence and convenience
Recurrence reduction	Demonstrated superior or comparable efficacy	Variable, higher with multi-dose therapies	Market differentiation focused on efficacy and compliance
Pricing	Premium but justified by single-dose regimen	Lower, but compliance issues	Reimbursement impact and payer willingness
Regulatory status	Approved in US and EU	Widely established	Market access advantage for SOLOSEC

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Key Takeaways

• Market Position: SOLOSEC uniquely benefits from a single-dose regimen, high efficacy, and favorable safety profile, positioning it strongly within the BV treatment landscape.
• Growth Drivers: Expanding global awareness, reimbursement coverage, and potential new indications underpin the financial trajectory.
• Challenges: Competition from established therapies, regulatory hurdles in emerging markets, and payer negotiations could influence growth.
• Financial Trajectory: Expect rapid revenue growth with CAGR estimates of 40-60% over 2023-2028, reaching potentially $600 million in sales.
• Strategic Priorities: Focus on expanding geographic reach, securing broad reimbursement, and exploring additional indications will be critical to maximizing SOLOSEC’s commercial potential.

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FAQs

1. What makes SOLOSEC a preferred treatment for BV?
Its single-dose oral administration offers higher patient adherence, with clinical trials showing superior efficacy and reduced recurrence compared to traditional multi-dose regimens.

2. How does SOLOSEC's pricing compare with other BV treatments?
While more expensive upfront (~$400–$500 per dose), the convenience and efficacy may justify the premium, especially considering reduced recurrence and adherence benefits.

3. What are the current barriers to international market expansion?
Regulatory approvals, reimbursement policies, and provider awareness vary by country, representing hurdles that require tailored strategies.

4. How might emerging antibiotic resistance affect SOLOSEC’s market?
As secnidazole is a nitroimidazole, resistance development remains a concern; however, current resistance rates are low, and stewardship programs aim to preserve efficacy.

5. Are there upcoming indications or formulations for SOLOSEC?
Developmental pipelines include new formulations and potential indications such as trichomoniasis, which could further enhance its market footprint.

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References

[1] Centers for Disease Control and Prevention (CDC). Bacterial Vaginosis. 2020.
[2] Schwebke JR, et al. Recurrent bacterial vaginosis: a review of pathogenesis, recurrence, and management. Curr Infect Dis Rep. 2018;20(1):1-9.