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. Two 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:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	3,493
Drug Prices:	Drug price information for NATROBA
Drug Sales Revenues:	Drug sales revenues 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
Cipher	NATROBA	spinosad	SUSPENSION;TOPICAL	022408-001	Jan 18, 2011	6,342,482

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/002233 Treatment 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
Australia	6641490
Denmark	174489
Israel	92743
Japan	H02223589	MACROLIDE COMPOUND
South Africa	200007322	Formulations for controlling human lice.

Supplementary Protection Certificates for NATROBA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0375316	06C0047	France		PRODUCT NAME: SPINOSAD; REGISTRATION NO/DATE IN FRANCE: 2060098 DU 20060628; REGISTRATION NO/DATE AT EEC: 9275/B DU 20011023
0375316	350009	Netherlands
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	SPC/GB02/028	United Kingdom		PRODUCT NAME: SPINOSAD; REGISTERED: CH W 6020 20010313; UK 0714 20020227

Market Dynamics and Financial Trajectory for the Drug: NATROBA

Introduction

Natroba, a topical treatment containing Spinosad, has been a significant player in the anti-parasitic market, particularly for the treatment of head lice and scabies. Here, we delve into the market dynamics and financial trajectory of Natroba, especially following its acquisition by Cipher Pharmaceuticals.

Market Overview

The global lice treatment market is projected to grow substantially, with the market size expected to reach USD 1,730.08 million by 2031, growing at a CAGR of 6.40% from 2023 to 2031[1].

Market Share and Competition

In the U.S. anti-parasitic market, Natroba (Spinosad) holds a significant market share of approximately 22.1%, while permethrin, the market leader, holds around 71.4% despite its decreasing effectiveness due to resistance developed by lice and scabies mites[4].

Acquisition by Cipher Pharmaceuticals

Cipher Pharmaceuticals acquired the global product rights for Natroba from ParaPRO LLC in July 2024 for a total consideration of US$89.5 million. This acquisition included the commercial sales team in the United States and global product rights for Natroba and its authorized generic[4].

Financial Details of the Acquisition

• Cipher paid US$80 million in cash and issued US$9.5 million in common shares to ParaPRO.
• The acquisition was funded through a combination of cash on hand and a new credit facility from the National Bank of Canada[4].

Financial Performance Post-Acquisition

The acquisition of Natroba has significantly impacted Cipher Pharmaceuticals' financial performance.

Revenue Growth

• Total revenue for Q3 2024 increased by 71% to $10.4 million, primarily driven by a 213% increase in product revenue to $9.3 million compared to Q3 2023.
• Natroba and its authorized generic contributed $5.4 million in product revenue in Q3 2024[2][3].

Gross Margin and Profitability

• The gross margin on product revenue increased by 15% to 79% in Q3 2024, compared to 64% in Q3 2023, due to the higher gross margin from the acquired Natroba business.
• Total gross profit year-to-date Q3 2024 was $17.4 million, up from $13.1 million for the same period in the previous year[2][3].

Adjusted EBITDA

• Adjusted EBITDA for Q3 2024 was $4.1 million, an increase of 13% compared to Q3 2023.
• Year-to-date Q3 2024 adjusted EBITDA was $10.7 million, a 9% increase from the same period in the previous year[2][3].

Business Strategy and Outlook

Cipher Pharmaceuticals has outlined several key strategies to drive growth and maximize the potential of Natroba.

Integration and Market Expansion

• Integrating the acquired Natroba business with the existing Cipher business.
• Driving growth of Natroba in the U.S. anti-parasitic market, where it currently holds a 23% market share[3].

Global Expansion

• Out-licensing Natroba globally, particularly in warm climate regions where there is high unmet need.
• Submitting Natroba for Health Canada approval and commercializing it in Canada through existing infrastructure[4].

Complementary Products

• Acquiring complementary dermatology products to enhance the profitability, size, and scale of the business.
• Collaborating with Moberg Pharma on the MOB-015 Phase III clinical trial in the U.S. and assessing its potential in the Canadian market[3].

Market Growth Opportunities

The acquisition of Natroba presents significant growth opportunities for Cipher Pharmaceuticals.

Unmet Need

• Natroba addresses the unmet need for effective treatments against head lice and scabies, especially given the resistance developed to permethrin products.
• The FDA exclusivity and patent protection for the scabies indication until 2033 further solidify Natroba's market position[4].

Market Potential

• The global market potential for Natroba is substantial, given the widespread issue of lice and scabies resistance to traditional treatments.
• Cipher plans to leverage the experienced sales and marketing team from ParaPRO to drive growth in the U.S. and globally[4].

Challenges and Considerations

While the acquisition of Natroba is promising, there are several challenges and considerations.

Transaction Costs and Amortization

• The acquisition was associated with significant transaction costs and increased amortization of acquired intangible assets, which impacted net income and earnings per share in Q3 2024[2][3].

Licensing Revenue

• Licensing revenue decreased by 66% in Q3 2024 due to lower product shipments and royalties from the Absorica portfolio, which is a temporary setback but highlights the need for diversified revenue streams[2][3].

Key Takeaways

• Acquisition Impact: The acquisition of Natroba has significantly boosted Cipher Pharmaceuticals' revenue and gross margin.
• Market Position: Natroba holds a substantial market share in the U.S. anti-parasitic market and has potential for global expansion.
• Growth Strategies: Cipher is focusing on integrating the Natroba business, driving growth in the U.S., and out-licensing globally.
• Challenges: Transaction costs and decreased licensing revenue are short-term challenges that need to be addressed.

FAQs

What is Natroba and how is it used?

Natroba is a topical treatment containing Spinosad, used for the treatment of head lice and scabies. It is recognized for its effectiveness in providing a complete cure with a single application.

Who acquired Natroba and when?

Cipher Pharmaceuticals acquired the global product rights for Natroba from ParaPRO LLC in July 2024.

What was the financial impact of the acquisition on Cipher Pharmaceuticals?

The acquisition led to a significant increase in product revenue and gross margin for Cipher Pharmaceuticals, with total revenue for Q3 2024 increasing by 71% and gross margin on product revenue increasing by 15%.

What are the key strategies for driving growth of Natroba?

Cipher plans to integrate the Natroba business, drive growth in the U.S. market, out-license Natroba globally, and acquire complementary dermatology products.

What challenges did Cipher Pharmaceuticals face post-acquisition?

Cipher faced significant transaction costs, increased amortization of acquired intangible assets, and a decrease in licensing revenue.

Sources

1. Straits Research: Lice Treatment Market Size, Share and Forecast to 2031
2. Cipher Pharmaceuticals: Third Quarter 2024 Results
3. BioSpace: Cipher Pharmaceuticals Reports Third Quarter 2024 Results
4. Cipher Pharmaceuticals: Acquisition of Profitable Growth Dermatology Products from ParaPRO
5. Cipher Pharmaceuticals: MANAGEMENT'S DISCUSSION AND ANALYSIS Q3 2024