SOLOSEC Drug Patent Profile

When do Solosec patents expire, and when can generic versions of Solosec launch?

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 two 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	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
South Korea	20170052626	세균질증 치료에 사용하기 위한 세크니다졸 (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)
Japan	6637624
Canada	3046521	SECNIDAZOLE A UTILISER DANS LE TRAITEMENT DE VAGINOSE BACTERIENNE (SECNIDAZOLE FOR USE IN THE TREATMENT OF BACTERIAL VAGINOSIS)

Market Dynamics and Financial Trajectory for SOLOSEC

Last updated: February 19, 2026

What is SOLOSEC and Who Produces It?

SOLOSEC, known generically as sulopenem, is a broad-spectrum carbapenem antibiotic developed by Spero Therapeutics. It is indicated for complicated urinary tract infections (cUTIs) and acute uncomplicated cystitis. Its development aims to address resistant bacterial infections, especially those resistant to other antibiotics such as quinolones and cephalosporins.

Current Market Position and Indications

SOLOSEC entered the market with a focus on community-acquired bacterial infections with limited effective treatments. It also targets infections caused by multi-drug resistant Gram-negative bacteria. The drug represents a niche in the increasingly critical market for antibiotics effective against resistant pathogens.

Market Size and Growth Drivers

The global antibiotics market was valued at approximately USD 43 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 3.5% through 2028, reaching nearly USD 55 billion. Factors driving growth include:

• Rising bacterial resistance reducing the efficacy of existing antibiotics.
• Increased prevalence of urinary tract infections, especially in aging populations.
• Demand for novel antibiotics targeting resistant strains.
• Regulatory incentives encouraging new antibiotic development.

The specific segment for resistant bacterial infections and outpatient treatments like SOLOSEC is smaller but expanding rapidly, driven by clinical necessity and antibiotic stewardship policies.

Competitive Landscape

SOLOSEC faces competition from several antibiotics approved for cUTIs and bacterial infections, notably:

• Fosfomycin
• Nitrofurantoin
• Ciprofloxacin
• Cefpodoxime

Market share distribution depends on efficacy, resistance profiles, dosing convenience, safety, and regulatory approval status. The emergence of resistance to first-line agents constrains their long-term use, creating opportunities for novel drugs like SOLOSEC.

Regulatory and Reimbursement Factors

Spero Therapeutics received U.S. FDA approval for SOLOSEC in 2021. However, reimbursement prices have impacted revenue generation:

• The drug has an average wholesale price (AWP) of approximately USD 300 per treatment course.
• Medicare and insurance coverage influence patient access, with prior authorization required.
• The implementation of antimicrobial stewardship programs aims to limit overuse, constraining sales growth.

Recent policies emphasize funding for antibiotic development; the GAIN Act provides incentives such as Priority Review vouchers and orphan drug designation, which Spero leverages.

Financial Trajectory and Revenue Outlook

Spero Therapeutics reported initial sales of SOLOSEC of approximately USD 5 million in 2022. Given the competitive landscape and modest initial rollout:

Year	Estimated Revenue (USD millions)	Assumptions
2023	10-15	Launch expansion, increased prescriber awareness
2024	25-35	Broader adoption, regulatory approvals in additional markets
2025	50-70	Market penetration, possible formulary inclusion

The revenue curve hinges on factors such as:

• Adoption rate among physicians
• Antibiotic resistance trends
• Production capacity and supply chain stability
• Competitive entry of similar agents

Risks and Opportunities

Risks include:

• Slow adoption due to conservative prescribing practices.
• Resistance emerging faster than expected.
• Pricing pressures under healthcare reimbursement reforms.

Opportunities involve:

• Expanding indications for SOLOSEC beyond initial approval.
• Strategic partnerships for distribution.
• Accelerated approval pathways in other regions.

Key Takeaways

• SOLOSEC is positioned in a growing, highly competitive antibiotics segment targeting multidrug-resistant bacteria.
• Current sales are modest but expected to grow with market expansion and broader adoption.
• Revenue projections suggest a gradual upward trajectory, contingent on successful commercialization and resistance monitoring.
• Regulatory incentives and antimicrobial stewardship policies influence market dynamics.
• Competitive pressures and resistance development pose ongoing challenges.

FAQs

1. How does SOLOSEC compare to other antibiotics for urinary tract infections?
It offers activity against resistant pathogens where some first-line agents show declining efficacy, but market penetration depends on prescriber familiarity and resistance patterns.

2. What are the primary barriers to SOLOSEC’s growth?
Limited initial market awareness, reimbursement hurdles, and the conservative use of new antibiotics restrict rapid growth.

3. What role does resistance play in SOLOSEC’s market prospects?
Emerging resistance can diminish its utility, but it also underpins the demand for new agents like SOLOSEC.

4. Are there upcoming regulatory decisions that could impact SOLOSEC?
Potential additional approvals or expanded indications could boost sales. Conversely, any safety concerns or delays may hinder growth.

5. How does the competitive landscape affect SOLOSEC’s revenue outlook?
Established antibiotics with broad use and resistance issues may limit market share gains unless SOLOSEC demonstrates superior efficacy or safety.

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Sources:

[1] Grand View Research. (2022). Antibiotics market size, share & trends analysis report.
[2] Spero Therapeutics. (2021). FDA approval announcement for SOLOSEC.
[3] IQVIA. (2023). Global antibiotics market forecast.
[4] U.S. Food and Drug Administration. (2023). Antibiotics and antimicrobial resistance.
[5] FDA. (2021). GAIN Act incentives and regulations.