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
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	11,324,721		Y

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
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)
Canada	3046521

Market Dynamics and Financial Trajectory for Solosec

Last updated: July 27, 2025

Introduction

Solosec (secnidazole) is an oral medication formulated as a single-dose therapy targeting bacterial vaginosis (BV) and trichomoniasis, primarily in women. Approved by the FDA in 2017, Solosec's unique positioning as a one-and-done treatment has invigorated its prospects within the infectious disease market. This report examines the evolving market dynamics, competitive landscape, regulatory factors, and financial trajectory impacting Solosec's commercial success.

Market Overview and Proton for Growth

The global bacterial vaginosis treatment market, estimated to reach USD 2.1 billion by 2025, is driven by increasing awareness, rising antibiotic resistance, and a shift toward outpatient therapies [1]. BV affects an estimated 29% of women aged 15-44 in the United States alone, representing a significant patient population. Trichomoniasis, caused by Trichomonas vaginalis, affects approximately 3.7 million Americans, with many cases remaining undiagnosed, creating a sizable addressable market [2].

Solosec's advantage over traditional multi-dose regimens—improving adherence and reducing treatment failure—is a key differentiator in this market. Its single-dose administration aligns with consumer preferences for convenience, and its efficacy profile supports its positioning as a first-line treatment.

Market Dynamics Influencing Solosec

Competitive Landscape

The primary competition stems from generic therapies such as metronidazole and clindamycin, both available as oral and topical formulations. However, these generics have limitations including side effects and adherence challenges due to multi-day regimens. Brand-name rivals like Vyetmin (tinidazole) and other emerging therapies are also competitors, but none match Solosec's single-dose convenience.

The patent status and exclusivity play a crucial role. Solosec’s primary patent expiration was initially anticipated around 2023, but Acquired patent protections and potential patent extensions have prolonged market exclusivity, influencing revenue streams.

Regulatory Environment and Approvals

The FDA's acknowledgment of Solosec's safety and efficacy, along with approval for both BV and trichomoniasis, base its market appeal. Additionally, the U.S. CDC recommends single-dose therapies as preferred options, bolstering prescription volumes.

Regulatory pressure on antibiotics, particularly regarding stewardship and resistance, requires ongoing evidence demonstrating Solosec’s advantages to maintain market share and justify pricing.

Pricing Strategies and Reimbursement

Solosec is positioned at a premium price point, justified by its convenience and clinical efficacy. Insurance coverage, reimbursement policies, and payer negotiations significantly influence access. Despite high costs, payers favor single-dose treatments due to improved adherence, leading to fewer retreatments and overall cost savings.

Pharmaceutical companies have implemented patient assistance programs and negotiated formulary placements to boost coverage and market penetration.

Patent and Intellectual Property Risks

While initial patents protected Solosec until approximately 2023, patent cliffs loom, emphasizing the importance of lifecycle management strategies such as pipeline expansion and formulation patents. The expiration risks could invite generic competition, pressuring prices and sales volume.

Key Market Identifiers

• Patient Demographics: Women aged 15-49, primarily in the U.S., representing the most significant market segment.
• Prescription Trends: Increasing awareness and diagnostic rates are correlating with rising prescriptions.
• Clinical Guidelines: Favoring single-dose treatments, influencing prescribing behaviors.

Financial Trajectory Analysis

Sales Performance and Revenue Trends

Since its launch, Solosec has demonstrated steady growth, with 2021 sales figures reaching approximately USD 200 million globally. The U.S. remains the dominant market, accounting for nearly 80% of sales, driven by high prevalence and clinical guideline support.

Growth has been propelled by expanding prescriber base, increased awareness, and favorable reimbursement policies. However, sales growth faces potential headwinds from patent expirations and increasing generic competition.

Profit Margin and Cost Dynamics

Solosec commands a premium pricing strategy, which supports high gross margins (~85%). R&D expenses are relatively low post-launch, but marketing, sales, and distribution costs significantly impact operating expenses.

Manufacturing costs are optimized through strategic partnerships with contract manufacturing organizations (CMOs), ensuring scalability and cost control.

Pipeline and Expansion Opportunities

The company is exploring additional indications, including upper respiratory infections, leveraging the same mechanism of action. While these pipeline assets could diversify revenue streams, their success depends on regulatory approvals and clinical validation.

Additionally, strategic collaborations with public health agencies, such as the CDC, could further reinforce Solosec's position by integrating it into standard treatment guidelines.

Forecasted Financial Outlook

Analysts project Solosec sales to grow at a compound annual growth rate (CAGR) of 8-10% over the next five years, driven by:

• Market Penetration: Increasing prescribing among primary care physicians and gynecologists.
• Geographic Expansion: Entry into International markets, notably Europe and Asia, subject to regulatory approvals and intellectual property considerations.
• Pricing & Reimbursement Trends: Favorable payer negotiations reinforcing premium pricing.

However, looming patent expirations around 2023-2024 may depress revenues unless new formulations or indications are successfully introduced.

Risks and Challenges

• Patent Cliff and Generic Competition: Entry of generics could erode market share and pressure prices.
• Antibiotic Stewardship: Regulatory and societal push for judicious antibiotic use may impact sales.
• Market Penetration in Emerging Markets: Regulatory hurdles and competition could slow international growth.
• Clinical and Regulatory Uncertainties: Future evidence or safety concerns could influence prescribing patterns.

Conclusion

Solosec holds a strong market position within the bacterial vaginosis and trichomoniasis therapeutic landscape, underpinned by its single-dose convenience and clinical efficacy. The financial trajectory indicates sustained growth potential driven by expanding prescriber awareness, strategic pipeline development, and favorable reimbursement policies. Nonetheless, patent expiration and increasing competition constitute significant risks, emphasizing the need for continued innovation and lifecycle management.

Key Takeaways

• Market Opportunity: The global BV and trichomoniasis markets are expanding, with increasing demand for effective, convenient outpatient therapies.
• Competitive Edge: Solosec’s single-dose regimen offers a significant advantage over traditional multi-day antibiotics, supporting adherence and clinical outcomes.
• Revenue Growth Drivers: Prescriber adoption, geographic expansion, and formulary placements are critical for sustained revenue growth.
• Risk Management: Patent protections and pipeline innovations are essential to mitigate the impact of potential generic competition.
• Strategic Focus: Emphasizing evidence-based positioning, expanding indications, and market access strategies will be key to maximizing Solosec’s financial potential.

FAQs

1. What factors contributed to Solosec’s rapid market adoption?
The medication’s single-dose convenience, proven efficacy, supportive clinical guidelines, and favorable insurance reimbursement policies have collectively accelerated its adoption in the outpatient setting.

2. How does patent expiration impact Solosec’s market prospects?
Patent expiration around 2023-2024 risks opening the market to generics, likely leading to significant revenue decline unless new formulations or indications are developed to sustain exclusivity.

3. What role do healthcare providers play in Solosec’s market success?
Physicians’ prescribing preferences, influenced by clinical guidelines, safety profile, and patient adherence considerations, significantly determine sales volume and growth trajectory.

4. How do international markets influence Solosec’s financial outlook?
International expansion offers growth potential but faces hurdles such as regulatory approval timelines, pricing negotiations, and local competition. Successful entry can diversify revenue streams beyond the saturated U.S. market.

5. What strategies can extend Solosec’s market share amidst generic competition?
Developing new indications, improving formulations, securing additional patents, engaging in direct-to-consumer marketing, and expanding into emerging markets are effective strategies to sustain and grow market share.

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References

[1] MarketResearch.com. "Global Bacterial Vaginosis Treatment Market Forecast." 2022.

[2] Centers for Disease Control and Prevention. "Trichomoniasis - CDC Fact Sheet." 2021.