CYANOKIT Drug Patent Profile

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

Cyanokit is a drug marketed by Btg Intl and is included in one NDA.

The generic ingredient in CYANOKIT is hydroxocobalamin. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydroxocobalamin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cyanokit

A generic version of CYANOKIT was approved as hydroxocobalamin by ACTAVIS on December 31^st, 1969.

Summary for CYANOKIT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	3
Drug Prices:	Drug price information for CYANOKIT
What excipients (inactive ingredients) are in CYANOKIT?	CYANOKIT excipients list
DailyMed Link:	CYANOKIT at DailyMed

See drug prices for CYANOKIT

Recent Clinical Trials for CYANOKIT

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

Sponsor	Phase
Mayo Clinic	Phase 4
Ain Shams University	Phase 2/Phase 3
Medical College of Wisconsin	Phase 2

See all CYANOKIT clinical trials

Pharmacology for CYANOKIT

Drug Class

Antidote

US Patents and Regulatory Information for CYANOKIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-002	Dec 15, 2006		DISCN	No	No
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-001	Apr 8, 2011		RX	Yes	Yes

Expired US Patents for CYANOKIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-002	Dec 15, 2006	5,834,448
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-001	Apr 8, 2011	5,834,448

EU/EMA Drug Approvals for CYANOKIT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
SERB SA	Cyanokit	hydroxocobalamin	EMEA/H/C/000806Treatment of known or suspected cyanide poisoning.Cyanokit is to be administered together with appropriate decontamination and supportive measures.	Authorised	no	no	no	2007-11-23

International Patents for CYANOKIT

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

Country	Patent Number	Title	Estimated Expiration
Japan	3699223
Germany	69619767
Norway	315495

Market Dynamics and Financial Trajectory for CYANOKIT

Last updated: November 16, 2025

Introduction

Cyanokit, a brand of hydroxocobalamin, is a critical antidote for cyanide poisoning, approved by the U.S. Food and Drug Administration (FDA) in 2006. The drug's unique pharmacologic profile and its pivotal role in emergency medicine position it prominently within the rare but essential drug market. This analysis explores the evolving market landscape, key drivers shaping demand, competitive forces, regulatory influences, and the financial outlook for Cyanokit, offering strategic insights for industry stakeholders.

Pharmaceutical Overview of Cyanokit

Cyanokit (hydroxocobalamin) is an injectable form of vitamin B12 with a high affinity for cyanide ions. Upon administration, hydroxocobalamin binds cyanide to form cyanocobalamin, which is excreted renally. Its rapid action makes it indispensable in acute cyanide toxicity cases, especially in fire-related inhalation incidents and industrial exposures. Cyanokit is marketed predominantly in the United States, with limited availability in international markets, often through specialized channels or compassionate use programs.

Market Dynamics

1. Market Size and Growth Drivers

The global cyanide antidote market remains relatively niche, driven predominantly by the incidence of cyanide poisoning and institutional preparedness. Market estimates suggest moderate growth, projected at a Compound Annual Growth Rate (CAGR) of approximately 4-6% over the next five years.

• Incidence of Cyanide Poisoning: Although largely associated with industrial accidents, cyanide poisoning also occurs through smoke inhalation during fires, with estimates reporting thousands of cases annually worldwide [1]. Emergency response protocols and healthcare infrastructure influence treatment rates.

• Industrial Applications: Industries utilizing cyanide compounds, including gold mining, chemical manufacturing, and electroplating, contribute to the overall exposure risk. Strict safety standards and regulatory compliance may impact demand.

• Advancements in Emergency Response: Increased training, availability of antidotes like Cyanokit in emergency services, and improved diagnostic capabilities amplify immediate treatment access and utilization.

2. Regulatory Landscape and Approvals

Regulatory bodies, especially in the U.S., consistently recognize Cyanokit as a life-saving antidote, supporting its market presence. However, regulatory hurdles regarding labeling, indications, and off-label use can influence market expansion, especially internationally.

• FDA Approvals and Labeling: The FDA’s designation of Cyanokit as a Breakthrough Therapy in certain contexts accelerates approval processes and broadens access pathways.

• Approval in Emerging Markets: Countries with rising industrial activity seek FDA-recognized antidotes, presenting growth opportunities, contingent upon navigating local regulatory procedures.

3. Competitive Environment

While Cyanokit dominates the niche market, alternatives like Sodium Thiosulfate and other cyanide antidotes are available but typically less effective in rapid emergency scenarios.

• Market Entry Barriers: High development costs, limited patient populations, and regulatory hurdles deter new entrants.

• Generic Development: As patents expire, potential for generic hydroxocobalamin could influence pricing and profitability dynamics.

4. Price and Reimbursement Trends

Pricing strategies for Cyanokit are influenced by emergency use importance, manufacturing costs, and reimbursement frameworks. Insurance coverage, government procurement programs, and hospital formulary placements significantly impact revenue realization.

• Pricing Trends: Historically, Cyanokit’s unit costs are high due to manufacturing complexity and small market scale. Industry pressure for cost reduction may lead to price adjustments.

• Reimbursement Policies: Advocacy for inclusion within emergency and critical care coverage enhances accessibility and market penetration.

5. Supply Chain and Manufacturing Considerations

Manufacturing hydroxocobalamin involves sophisticated biotechnological processes and stringent quality controls. Supply chain disruptions, such as raw material shortages or regulatory compliance, could pose risks to consistent supply.

• Manufacturing Capacity: Expansion to meet global demand requires substantial investment, with regional production facilities being strategic assets.

Financial Trajectory Analysis

1. Revenue Forecasts

Based on current demand, market penetration, and expansion opportunities, revenue for Cyanokit is forecasted to grow at a conservative CAGR of approximately 4-6%.

• United States Market: As the primary revenue hub, growth will be driven by increased emergency preparedness, hospital adoption, and possibly, new indications.

• International Markets: Growth prospects depend on regulatory approvals, awareness campaigns, and infrastructural development in emerging economies.

2. Profitability Outlook

Margins are influenced by manufacturing costs, pricing strategies, and reimbursement rates. Cost efficiencies from potential biosimilar or generic entrants could pressure profit margins over time. Conversely, exclusive rights and high demand in emergency settings support premium pricing, sustaining margins.

3. R&D and Pipeline Opportunities

Though Cyanokit remains an FDA-approved, well-established product, ongoing research into broader indications, alternative formulations, and combination therapies could diversify revenue streams. Such innovations warrant substantial R&D investments but carry promising long-term financial benefits.

4. Strategic Risks and Opportunities

• Risks: Supply chain instability, regulatory delays in international markets, emerging competitors, and potential patent expirations pose threats to revenue continuity.

• Opportunities: Strategic alliances, geo-expansion, and integration into broader emergency response systems could propel growth. Additionally, capturing segment share in hospital emergency kits enhances market dominance.

Regulatory and Geopolitical Influences

Global health policies emphasizing preparedness for chemical—particularly cyanide—exposures can catalyze demand. Regulatory harmonization in emerging markets simplifies approval pathways. Conversely, stringent control measures or geopolitical instability may restrict market access.

Conclusion

Cyanokit’s market remains small but vital, underpinned by its role in emergency medicine and industrial safety. Moderate yet steady growth is forecasted, contingent upon regulatory developments, market expansion, and healthcare infrastructure enhancements. The financial trajectory is characterized by resilience, with opportunities for diversification, but subject to inherent risks related to supply, competition, and policy changes.

Key Takeaways

• Cyanokit’s niche status and life-saving profile sustain steady demand amid limited competition.

• Market growth hinges on increased emergency preparedness, industrial safety protocols, and regulatory approvals, especially outside the U.S.

• Pricing and reimbursement strategies significantly impact revenue, with potential downward pressure from generics forthcoming.

• Supply chain resilience and manufacturing capacity are critical to meet global demand and maintain market share.

• Future growth avenues include international expansion, pipeline innovations, and integration into broader emergency response systems.

FAQs

Q1: What are the main drivers influencing Cyanokit’s demand globally?
A: Demand is driven by the incidence of cyanide poisoning cases, industrial activity involving cyanide use, emergency response preparedness, and regulatory recognition in various jurisdictions.

Q2: How might patent expirations affect Cyanokit’s market position?
A: Patent expirations could open the market to generic hydroxocobalamin, potentially reducing prices and impacting profit margins but also increasing accessibility.

Q3: What regulatory challenges could impact Cyanokit’s international market expansion?
A: Local approval processes, differing safety standards, and logistical barriers may delay or restrict access to emerging markets.

Q4: Are there significant R&D efforts aimed at expanding Cyanokit’s indications?
A: Currently, Cyanokit’s primary indication remains cyanide poisoning. Ongoing research into broader applications is limited but could emerge with further scientific evidence.

Q5: What strategic actions can industry stakeholders adopt to capitalize on Cyanokit’s market potential?
A: Stakeholders should focus on regulatory engagement, expanding manufacturing capacity, forming strategic alliances, and advocating for emergency protocol integrations to enhance demand.

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References

[1] WHO. (2022). Cyanide poisoning: Epidemiology and response strategies. World Health Organization.