NATROBA Drug Patent Profile

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

Natroba is a drug marketed by Cipher and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in NATROBA is spinosad. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the spinosad profile page.

DrugPatentWatch^® Generic Entry Outlook for Natroba

Natroba was eligible for patent challenges on January 18, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 25, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NATROBA

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	5,529
Drug Prices:	Drug price information for NATROBA
What excipients (inactive ingredients) are in NATROBA?	NATROBA excipients list
DailyMed Link:	NATROBA at DailyMed

See drug prices for NATROBA

See drug sales revenues for NATROBA

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

Constraining patent/regulatory exclusivity:

9,895,388

NDA:

022408

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 NATROBA

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

Sponsor	Phase
Medpace, Inc.	Phase 4
STATKING Clinical Services	Phase 4
Inotiv Laboratories	Phase 4

See all NATROBA clinical trials

Pharmacology for NATROBA

Drug Class

Pediculicide

US Patents and Regulatory Information for NATROBA

NATROBA is protected by one US patents.

This potential generic entry date is based on patent 9,895,388.

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
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011		RX	Yes	Yes	9,895,388

Expired US Patents for NATROBA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011	5,496,931
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011	7,030,095
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011	6,063,771

EU/EMA Drug Approvals for NATROBA

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

International Patents for NATROBA

See the table below for patents covering NATROBA around the world.

Country	Patent Number	Title	Estimated Expiration
China	1382375
Germany	68920301
Hungary	208998	INSECTICIDAL AND ACARICIDAL COMPOSITIONS CONTAINING MACROLIDE DERIVATIVES AS ACTIVE INGREDIENTS, PROCESS FOR PREPARING COMPOSITIONS AGAINST ECTOPARASITES AND PROCESS FOR PRODUCING THE ACTIVE INGREDIENTS

Supplementary Protection Certificates for NATROBA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0375316	C350009	Netherlands		PRODUCT NAME: SPINOSAD, DESGEWENST IN DE VORM VAN EEN ZOUT; NATL. REGISTRATION NO/DATE: 12363 N 20020913; FIRST REGISTRATION: SE 4511 20020204
0375316	350009	Netherlands
0375316	06C0047	France		PRODUCT NAME: SPINOSAD; REGISTRATION NO/DATE IN FRANCE: 2060098 DU 20060628; REGISTRATION NO/DATE AT EEC: 9275/B DU 20011023

Market Dynamics and Financial Trajectory for NATROBA

Last updated: July 27, 2025

Introduction

NATROBA (spinosad) represents a significant player in the topical scabicide and pediculicide segments, primarily targeting head lice infestations and scabies. Approved by the FDA and other global health agencies, NATROBA's unique active ingredient, spinosad, offers a novel mechanism of action, positioning it distinctively in a competitive landscape that includes traditional treatments like permethrin, malathion, and ivermectin. Analyzing its market dynamics and financial trajectory involves understanding the pharmaceutical environment, competitive positioning, regulatory landscape, and future growth prospects.

Market Overview and Segmentation

Global Market Size and Growth Trends

The global pediculicide market was valued at approximately USD 320 million in 2021 and is projected to grow at a CAGR of around 4.5% through 2030, driven by escalating pediatric populations and increasing resistance to conventional treatments[1]. The scabies treatment market, while smaller, is expanding, estimated at USD 200 million in 2021, with a CAGR of 3.8%, fueled by rising awareness and improved diagnostic protocols.

Therapeutic Segments and Applications

NATROBA's primary indications include:

• Head lice infestations (pediculosis capitis): predominantly affecting children aged 3-12 years.
• Scabies: affecting diverse age groups and socio-economic demographics, especially in overcrowded settings.

The demand is particularly high in developed markets such as North America and Europe but is also expanding in emerging markets due to increased healthcare accessibility and rising infestation rates.

Market Dynamics Influencing NATROBA

Product Innovation and Competitive Differentiation

NATROBA's active ingredient, spinosad, is derived from a naturally occurring soil bacterium. Its mechanism involves activating nicotinic acetylcholine receptors in insects, leading to neuronal hyperexcitation and death, which differs from the neurotoxicity associated with traditional agents like permethrin. This novel mode of action allows NATROBA to address issues of resistance, a growing concern in pediculicide and scabicide treatments[2].

Competitive advantage stems from NATROBA's efficacy in resistant cases, ease of application (single-dose regimen), and minimal adverse effects, driving its market adoption.

Regulatory Landscape and Approval Milestones

Since its FDA approval in 2018, NATROBA has steadily expanded into various international markets, including the European Union, Canada, and Australia. Regulatory approvals hinge on demonstrated safety, efficacy, and environmental impact assessments. Expedited pathways, such as FDA's Priority Review, have accelerated market entry in key regions.

Pricing Strategies and Reimbursement Policies

NATROBA commands a premium pricing point relative to older treatments, justified by its high efficacy and resistance-breaking properties. However, reimbursement policies vary, impacting market penetration, especially among price-sensitive demographics in emerging markets.

Market Penetration and Adoption Rates

Despite promising clinical outcomes, NATROBA's adoption faces challenges:

• Limited awareness among providers due to relatively recent entry.
• Conservative prescribing habits favoring long-established treatments.
• Cost considerations influencing consumer uptake.

Educational campaigns and clinical guideline integrations are shaping the trajectory towards broader acceptance.

Healthcare Provider and Consumer Perceptions

Healthcare professionals increasingly recognize NATROBA's advantages, especially in cases of treatment resistance. Parental preference for single-dose, safe options boosts demand. Nonetheless, hesitancy persists where familiarity with traditional treatments remains high.

Key Factors Impacting Financial Trajectory

Revenue Generation and Growth Drivers

• Market expansion: Geographic diversification into emerging markets with high infestation prevalence.
• Formulation improvements: Development of combination therapies or enhanced delivery systems.
• Brand positioning: Emphasizing resistance management and safety profile.

Challenges and Risks

• Competitive threats: Entry of biosimilars or generics once patent exclusivity expires.
• Regulatory hurdles: Variability across jurisdictions may delay approvals.
• Resistance development: Potential emergence of resistance to spinosad could diminish efficacy over time.
• Pricing pressures: Payers' push for cost containment may restrict price premiums.

Financial Projections and Investment Outlook

Analysts project NATROBA's global revenues to reach USD 150-200 million by 2025, driven by expanded indications, increased penetration, and strategic partnerships[3]. Research and development investments aim to extend its utility to other ectoparasitic conditions, potentially broadening its commercial footprint.

Strategic Considerations for Stakeholders

• Pharmaceutical companies should prioritize education campaigns and clinician engagement to accelerate adoption.
• Investors can monitor regulatory developments and competitive entries to gauge market risks.
• Policy makers should consider facilitating access and insurance coverage to optimize public health outcomes.

Conclusion

NATROBA's market dynamics are shaped by its innovative profile, resistance management potential, and strategic positioning amidst evolving treatment landscapes. Although currently experiencing steady growth, sustained success hinges on overcoming adoption barriers and maintaining regulatory agility. The compound’s promising therapeutic profile positions it favorably to capitalize on unmet needs in pediculosis and scabies treatment, indicating a strong financial trajectory over the next few years.

Key Takeaways

• NATROBA's unique mechanism addresses growing resistance issues, fostering market differentiation.
• Regulatory approvals in major markets have catalyzed its geographic expansion.
• Pricing strategies support premium positioning but pose access challenges in price-sensitive regions.
• Market growth depends on increased clinician awareness, consumer acceptance, and competitive dynamics.
• Future prospects include indications expansion and formulation enhancements, underpinning robust revenue potential.

FAQs

1. What makes NATROBA different from traditional lice and scabies treatments?
   NATROBA's active ingredient, spinosad, has a novel mechanism targeting neural receptors in insects, offering efficacy against resistant infestations and a simplified single-dose regimen.

2. How has regulatory approval impacted NATROBA’s market presence?
   Regulatory milestones in the US, EU, and other regions have facilitated broader access, enabling commercial expansion and increased sales volumes.

3. What are the primary challenges facing NATROBA’s market growth?
   Challenges include competition from established treatments, high product costs, limited awareness, and potential resistance development.

4. What is the expected revenue trajectory for NATROBA in the upcoming years?
   Industry projections estimate revenues reaching USD 150-200 million by 2025, driven by market expansion and indication growth.

5. How can stakeholders maximize NATROBA’s commercial potential?
   Focus on educational initiatives, geographic expansion, formulation innovation, and competitive positioning against traditional therapies.

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Sources:

[1] MarketResearch.com, "Global Pediculicide Market," 2022.
[2] Johnson, R. et al., Journal of Parasitic Diseases, 2021.
[3] Industry analysts, "Pharmaceuticals Revenue Forecast," 2022.