SPINOSAD - Generic Drug Details

What are the generic sources for spinosad and what is the scope of freedom to operate?

Spinosad is the generic ingredient in one branded drug marketed by Cipher and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for spinosad. Three suppliers are listed for this compound.

Summary for SPINOSAD

US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	10
Drug Prices:	Drug price trends for SPINOSAD
What excipients (inactive ingredients) are in SPINOSAD?	SPINOSAD excipients list
DailyMed Link:	SPINOSAD at DailyMed

See drug prices for SPINOSAD

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

Dosage:

SUSPENSION;TOPICAL

^*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 SPINOSAD

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

Sponsor	Phase
Aperta Biosciences, LLC	PHASE2
MicroConstants, Inc.	Phase 4
Concentrics Research	Phase 4

See all SPINOSAD clinical trials

Pharmacology for SPINOSAD

Drug Class

Pediculicide

US Patents and Regulatory Information for SPINOSAD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011		RX	Yes	Yes

Expired US Patents for SPINOSAD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011

EU/EMA Drug Approvals for SPINOSAD

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Elanco GmbH	Comfortis	spinosad	EMEA/V/C/002233Treatment and prevention of flea infestations (Ctenocephalides felis).The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product.The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).	Withdrawn	no	no	no	2011-02-11

Market Dynamics and Financial Trajectory for Spinosad: A Comprehensive Analysis

Last updated: July 29, 2025

Introduction

Spinosad stands as a prominent biopesticide derived from the soil bacterium Saccharopolyspora spinosa. Originally developed for agricultural pest control, its favorable environmental profile and efficacy against a broad spectrum of pests have catalyzed its adoption across various sectors. As global regulatory landscapes evolve and sustainable farming practices gain prominence, understanding the market dynamics and financial trajectory of Spinosad is pivotal for stakeholders, from pharmaceutical companies to agricultural product distributors.

This analysis offers an in-depth exploration of factors shaping Spinosad’s market performance, competitive positioning, regulatory influences, and future growth prospects.

Market Overview and Segmentation

Spinosad primarily operates within the biopesticide segment, targeting crop protection, pest control, and increasingly, vector-borne disease management. The compound is marketed under various brand names, including Entrust (Dow AgroSciences) and Natular (Clarke).

The global biopesticides market valued at approximately USD 3.0 billion in 2022 is projected to grow at a CAGR of 14% through 2030, with Spinosad accounting for a significant share owing to its proven efficacy and eco-friendly profile [1].

Segmented by application:

• Agricultural Pest Control: Dominates the market, especially for high-value crops such as cotton, vegetables, and fruits.
• Public Health: Increasingly used for controlling disease vectors such as Aedes aegypti, Anopheles, and Culex mosquitoes, especially in regions combating vector-borne illnesses like dengue, Zika, and malaria.
• Professional Pest Management: For urban pest control, including household and institutional applications.

Geographical markets:

• North America: Leading with robust research and adoption, driven by environmental regulations and consumer demand for sustainable products.
• Europe: Growing emphasis on organic farming supports market expansion; regulatory hurdles remain a challenge.
• Asia-Pacific: Fastest-growing, propelled by expanding agricultural sectors, government incentives, and increasing vector-borne diseases.
• Latin America and Africa: Emerging markets with increasing adoption due to cost benefits and regulatory approvals.

Market Drivers and Restraints

Drivers

1. Environmental Regulations and Consumer Demand: Stringent policies favoring eco-friendly pesticides bolster Spinosad’s appeal, especially as an alternative to conventional chemical insecticides [2].

2. Efficacy and Selectivity: Demonstrated high potency against pest larvae with minimal non-target effects enhances its attractiveness to farmers and regulators.

3. Integration into IPM: Its compatibility with integrated pest management (IPM) systems encourages broader adoption.

4. Public Health Applications: Rising vector-borne diseases in tropical regions incentivize the repurposing of Spinosad for mosquito control, expanding its market reach.

Restraints

1. Regulatory Barriers: Varying approval statuses across countries inhibit uniform market expansion. Certain regions exhibit delays in registration processes.

2. Cost Competitiveness: Generally higher than conventional chemical alternatives, which may limit adoption among cost-sensitive farmers.

3. Resistance Development: Overuse can lead to pest resistance, necessitating rotation strategies and limiting long-term sustainability.

4. Production Capacity Constraints: Scaling manufacturing to meet global demand remains a logistical challenge.

Competitive Landscape

Major players in the Spinosad market include Dow AgroSciences (now part of Corteva), Bayer, Sumitomo Chemical, and FMC Corporation. These companies invest heavily in R&D to enhance formulation efficacy, stability, and application methods, thereby maintaining market relevance [3].

Emerging bioinnovators and regional companies are also entering the space, fostering price competition and innovation. Patents related to specific formulations or delivery systems influence market access and pricing strategies.

Regulatory Environment and Its Influence

Regulatory approval directly impacts the market trajectory for Spinosad. In North America, the Environmental Protection Agency (EPA) has approved its use in various crops and for public health applications. The European Food Safety Authority (EFSA) maintains a rigorous assessment process, with recent approvals expanding Spinosad’s label indications.

In emerging markets, regulatory acceptance varies, often causing delays in commercialization. The clearance process typically entails rigorous environmental risk assessments and residue analyses, adding to cost and time-to-market.

Financial Trajectory and Investment Outlook

Revenue Trends

Spinosad has experienced steady revenue growth driven by its expanding application portfolio. According to industry reports, sales in 2022 approximated USD 350 million, with projections indicating reaching USD 700 million by 2030, contingent on factors including regulatory approvals, market expansion, and pesticide resistance management strategies [4].

Investment and R&D Expenditure

Major firms allocate approximately 10-15% of their biopesticides revenue towards R&D, focusing on enhanced formulations, resistance management, and new pest targets. Innovations such as microencapsulation and sustained-release formulations aim to extend product efficacy and shelf life, increasing market attractiveness.

Impact of COVID-19

The pandemic introduced supply chain disruptions but also underscored the importance of sustainable, health-conscious pest management solutions, indirectly benefiting Spinosad’s market positioning.

Market Risks and Opportunities

• Risks: Regulatory delays, resistance development, market saturation in mature regions.
• Opportunities: Expansion into vector control, organic farming markets, and integration with precision agriculture technologies.

Future Outlook and Growth Strategies

Projected growth hinges on advancing regulatory approvals, particularly in Latin America and Africa. Additionally, expanding public health applications in endemic regions offers substantial revenue upside.

Innovations in application technology, such as drone-based spraying and targeted delivery, promise to enhance efficacy and reduce costs. Partnerships with agricultural technology firms and governments bolster market penetration.

Moreover, sustainability trends and consumer preference for organic produce will propel the adoption of biopesticides like Spinosad.

Key Takeaways

• Growing Demand in Agriculture and Public Health: Market expansion driven by environmental policies and vector-borne disease control efforts.
• Regulatory Hurdles: Navigating approvals remains a pivotal challenge; proactive engagement and evidence-based submissions are essential.
• Competitive Innovation: Continual R&D investment by incumbents sustains competitive advantage, with emerging players intensifying innovation.
• Financial Growth prospects: Anticipated to reach USD 700 million by 2030, contingent on regulatory, ecological, and market adaptation factors.
• Sustainable Development Focus: Aligning product development with global sustainability goals enhances market credibility and acceptance.

FAQs

1. What are the primary applications of Spinosad?

Spinosad is primarily used as a biopesticide in agriculture for pest control, and increasingly in public health for mosquito and vector-borne disease management.

2. How does regulatory approval impact Spinosad’s market growth?

Regulatory approvals are critical; delays or denials limit market access. Streamlined, science-based regulatory processes facilitate quicker adoption and higher sales growth.

3. What advantages does Spinosad have over conventional chemical pesticides?

It offers high efficacy with minimal environmental impact, low toxicity to non-target organisms, and compatibility with organic farming practices—attributes increasingly valued by consumers and regulators.

4. What challenges does the market face regarding resistance?

Overuse can lead to pest resistance, reducing effectiveness. Integrated pest management strategies and rotation are necessary to mitigate this risk.

5. What is the outlook for public health applications of Spinosad?

Expanding in tropical regions, Spinosad-based formulations for mosquito control are expected to significantly grow, especially as vector-borne diseases remain a global health concern.

References

1. [1] Grand View Research, “Biopesticides Market Size & Share Analysis Report,” 2022.
2. [2] Environmental Protection Agency (EPA), “Registration of Spinosad for Agricultural and Public Health Use,” 2021.
3. [3] MarketWatch, “Competitive Landscape of Biopesticide Industry,” 2022.
4. [4] Fortune Business Insights, “Spinosad Market Forecast,” 2023.