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/000806 Treatment 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
Norway	315495
Japan	H09136837	NEW ADMINISTRATION EMBODIMENT OF HYDROXOCOBALAMINE AND ITS USE FOR PRUSSIC ACID INTOXICATION
Japan	3699223
Denmark	0775485
Australia	7172096
France	2740973	NOUVELLE FORME D'ADMINISTRATION DE L'HYDROXOCOBALAMINE ET SON UTILISATION DANS LES INTOXICATIONS PAR LES CYANURES
Iceland	4387

CYANOKIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CYANOKIT

Introduction to CYANOKIT

CYANOKIT, also known as hydroxocobalamin for injection, is a critical antidote for treating known or suspected cyanide poisoning. It has been a game-changer in emergency medicine, particularly in scenarios involving smoke inhalation, industrial accidents, and potential terrorist attacks.

Historical Approval and Licensing

CYANOKIT was first licensed in France in 1996 for the treatment of cyanide poisoning. It gained FDA approval in the United States in December 2006, marking a significant milestone in the availability of effective cyanide antidotes in the U.S. market[1][5].

European Market Authorization

Following its FDA approval, CYANOKIT received marketing authorization throughout the European Union in November 2007. This expansion was facilitated by the European Commission, highlighting the drug's efficacy and safety profile[3][5].

Market Need and Demand

Cyanide poisoning is a severe and often lethal condition, particularly in scenarios such as structural fires where smoke inhalation is common. In the U.S., smoke inhalation accounts for up to 80% of fire-related injuries and deaths. The approval of CYANOKIT addressed a critical gap in emergency medical response, providing a lifesaving treatment option for emergency responders and hospital staff[1].

Clinical Efficacy and Safety

Clinical studies have demonstrated CYANOKIT's efficacy in treating cyanide poisoning. A prospective open-label study involving 69 subjects exposed to smoke inhalation showed that 73% of patients survived following treatment with CYANOKIT and supportive care. The drug's safety profile is also notable, with temporary and modest side effects reported, and no severe adverse events directly related to CYANOKIT treatment observed[1][3].

Market Impact and Adoption

The introduction of CYANOKIT has had a significant impact on the survival rates of individuals exposed to cyanide. Emergency responders now have a reliable antidote that can be administered both in pre-hospital and hospital settings. This has improved the outcomes for patients who might otherwise have succumbed to cyanide poisoning[1].

Financial Trajectory

While specific financial figures for CYANOKIT are not detailed in the available sources, the drug's approval and subsequent market authorization suggest a positive financial trajectory. Here are some key points:

Revenue Potential

• The approval and widespread adoption of CYANOKIT would likely generate substantial revenue for the manufacturers, EMD Pharmaceuticals and Dey, LP. Given its critical role in emergency medicine, the demand for CYANOKIT is expected to be consistent, contributing to stable and potentially growing revenues.

Market Expansion

• The expansion into the European market following EU authorization in 2007 would have further boosted revenue. The drug's availability in multiple regions increases its market reach and potential for higher sales volumes[3][5].

Competitive Advantage

• CYANOKIT's unique mechanism of action and its approval as the first cyanide antidote in several decades in the U.S. give it a competitive edge. This exclusivity would contribute to higher revenue as it becomes the go-to treatment for cyanide poisoning[1].

Challenges and Considerations

Side Effects and Monitoring

• While CYANOKIT is generally well-tolerated, it does come with some side effects, such as transient chromaturia, erythema, and potential renal injury. These require careful monitoring, which could impact its adoption in some cases[4].

Interference with Laboratory Tests

• The drug's intense red color can interfere with laboratory tests, which might complicate patient care and monitoring. However, this is managed through proper communication and the use of stickers to alert healthcare staff[3][4].

Regulatory Oversight

• The risk management plan developed for CYANOKIT ensures its safe use, but ongoing regulatory oversight is necessary to maintain its market authorization. Compliance with these regulations is crucial for continued market presence[3].

Key Takeaways

• Approval and Licensing: CYANOKIT was approved by the FDA in 2006 and received EU marketing authorization in 2007.
• Clinical Efficacy: The drug has shown significant efficacy in treating cyanide poisoning, with a high survival rate in clinical studies.
• Market Impact: CYANOKIT has improved survival outcomes for individuals exposed to cyanide, particularly in fire-related incidents.
• Financial Trajectory: The drug's approval and market expansion suggest a positive financial trajectory, driven by consistent demand and a competitive edge.
• Challenges: Monitoring for side effects and interference with laboratory tests are key considerations.

FAQs

1. When was CYANOKIT approved by the FDA?

CYANOKIT was approved by the FDA in December 2006[1][5].

2. How is CYANOKIT administered?

The initial dose of CYANOKIT for adults is 5 g, administered by IV infusion over 15 minutes. A second dose of 5 g may be given if necessary, up to a total dose of 10 g[5].

3. What are the common side effects of CYANOKIT?

Common side effects include transient chromaturia, erythema, oxalate crystals in urine, rash, increased blood pressure, nausea, headache, and infusion site reactions[4].

4. Can CYANOKIT interfere with laboratory tests?

Yes, CYANOKIT's intense red color can interfere with colorimetric determination of certain laboratory parameters. This is managed through proper communication and the use of warning stickers[3][4].

5. Is CYANOKIT safe for use in pregnant women?

Based on animal studies, CYANOKIT may cause fetal harm, but its administration for cyanide poisoning may be lifesaving for the mother. Its use in pregnancy should be carefully considered[4].

Sources

1. FDA Approves EMD Pharmaceuticals, Inc. And Dey, L.P.'s Cyanokit ... - Biospace
2. Pioneer in Rare Diseases - Sobi - Sobi
3. Cyanokit | European Medicines Agency (EMA) - EMA
4. CYANOKIT-Training-Presentation_Nov2021.pdf - Cyanokit
5. Frequently Asked Questions | CYANOKIT® (hydroxocobalamin) - Cyanokit