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
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-001	Apr 8, 2011

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
Iceland	4387
Norway	315495
Denmark	0775485
Australia	7172096

CYANOKIT: Market Dynamics and Financial Trajectory

Last updated: May 3, 2026

What is CYANOKIT’s market positioning?

CYANOKIT is a cyanide antidote product used for suspected or confirmed cyanide poisoning, typically in emergency settings. Commercially, the product is positioned in a narrow but high-acuity therapeutic category where demand is driven by emergency preparedness, procurement cycles, and stock-rotation rather than routine prescribing.

Market demand is shaped by:

• Public-health and emergency stockpiling: Hospital and government inventories drive bulk purchase timing.
• Acute-care utilization variability: Real-world exposure events are sporadic and can cause short-term sales swings.
• Channel mix: Sales depend on how quickly product inventories turn at hospitals and distributors after procurement.

Which revenue drivers determine CYANOKIT’s financial trajectory?

CYANOKIT’s financial path typically follows three levers:

1. Institutional procurement cadence

   • Emergency departments and pharmacy networks buy in batches aligned to tender cycles and contract renewals.
   • Sales can rise sharply in quarters with large tenders or contract awards.

2. Inventory normalization

   • Post-procurement periods can show slower movement when hospital stock levels are sufficient.
   • This creates quarter-to-quarter volatility even when underlying need remains stable.

3. Geographic and reimbursement coverage

   • National procurement rules, reimbursement status, and formulary inclusion determine addressable market size.
   • Expansion into additional tender regions or contract wins increases the long-run ceiling.

What is the competitive and supply dynamic for cyanide antidotes?

Cyanide antidote markets have limited player depth, but competitive pressure and supply constraints can still matter:

• Therapeutic substitutability is limited: Most alternative options are also emergency cyanide antidotes with their own procurement pathways.
• Contracting can be lumpy: Once a buyer standardizes on a supplier, switching requires new evidence, contract renegotiation, and budget cycles.
• Continuity of supply is critical: Stockouts can result in lost procurement allocations that may shift to alternatives for later contracts.

How do pricing and payer rules influence CYANOKIT economics?

Pricing in emergency antidotes often works through:

• Tender-based pricing for government or large hospital group purchases.
• Reimbursement-linked pricing for commercial insurance, where applicable.
• Volume discounts and contract terms that compress realized price in bulk orders while sustaining unit demand.

The financial trajectory in this category often reflects a balance between:

• Realized gross price stability under long-term contracts
• Revenue growth driven by unit volume rather than broad, repeat-use prescribing

What does CYANOKIT’s financial trajectory depend on year to date?

CYANOKIT’s financial trajectory is driven by the following pattern that recurs across emergency specialty drugs:

• Revenue step-ups after large institutional purchases
• Mean reversion after inventory normalization
• Margin variation tied to logistics, procurement terms, and supply stability

That pattern typically produces:

• Higher volatility in quarterly revenue
• More stable annual trends if procurement wins offset occasional normalization periods

What market signals typically move CYANOKIT sales?

Key signals include:

• Emergency preparedness budget cycles (public-sector procurement)
• Contract renewals with hospital systems and national health services
• Awareness and guideline adoption that influences stocking behavior
• Exogenous event risk that can increase urgent case awareness and procurement re-stocking

What is the likely revenue shape by quarter?

For CYANOKIT, the expected quarter-to-quarter shape is:

• Upward spikes following procurement tenders or contract awards
• Declines or stabilization in subsequent quarters as stock levels normalize
• Sales leveling when contracts mature and distributors align inventories

This behavior is common in antidote and emergency countermeasure categories where orders are lumpy and inventory-driven rather than prescription-driven.

What are the main financial risks to CYANOKIT’s trajectory?

1. Order timing risk

   • Large purchases can shift across quarters based on tender award timing and delivery schedules.

2. Inventory and channel risk

   • Distributor and hospital stock can suppress reorders even when demand remains present.

3. Competitive and switching risk

   • Contracting can lock in a buyer to a competitor or alternate product during the next procurement cycle.

4. Supply chain risk

   • Any disruption that delays shipments can reduce fulfillment of contracted demand.

What is the business implication for investors and R&D planners?

• CYANOKIT’s near-term performance is more likely to be explained by procurement and inventory cycles than by broad market expansion.
• Sustained growth requires incremental access: new contracts, expanded institutional adoption, and geography coverage rather than generalized market penetration.

How should CYANOKIT be evaluated on a financial KPI basis?

The most decision-relevant KPIs for CYANOKIT’s trajectory include:

• Units delivered (captures procurement wins better than revenue alone)
• Realized price by channel (reveals tender pressure or contract strength)
• Inventory turnover trends at distributors and hospital groups (explains quarter-to-quarter swings)
• Contract pipeline and tender calendar visibility (ties forecasting to observable timing drivers)
• Gross margin stability (reflects supply performance and contract mix)

These KPIs align to the structural drivers of emergency antidote markets: institutional procurement, inventory normalization, and contract renewals.

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Key Takeaways

• CYANOKIT is an emergency, institutional procurement-driven drug where sales follow tender cycles and inventory rotation rather than routine prescribing.
• The financial trajectory typically shows lumpy quarterly revenue with mean reversion after stock normalization.
• Sustainable growth depends on incremental contract wins, geographic coverage, and channel access, with pricing and margin shaped by bulk procurement terms.
• Forecasting and performance evaluation should focus on units delivered, realized price, inventory turnover, and tender timing, not only headline revenue.

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FAQs

1) What drives CYANOKIT demand in the market?

Demand is driven by hospital and public-sector emergency preparedness procurement, which creates lumpy purchasing aligned to contract and stock-rotation cycles.

2) Why can CYANOKIT sales be volatile quarter to quarter?

Because procurement orders are batch-based and followed by inventory normalization, quarterly revenue can spike after tenders and then stabilize or decline.

3) What matters most for CYANOKIT’s forward sales outlook?

The critical drivers are new contract awards, tender timing, channel stocking behavior, and geographic expansion, which determine whether unit volume rises sustainably.

4) What financial risks are most relevant to this category?

The main risks are order timing, inventory overhang, contract switching to competitors, and supply continuity issues that affect fulfillment.

5) What KPIs best track CYANOKIT’s real performance?

Use units delivered, realized price by channel, gross margin stability, and procurement/tender timing indicators to explain and forecast performance.

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References (APA)

1. [No sources provided in the prompt.]