Ziconotide acetate - Generic Drug Details

What are the generic drug sources for ziconotide acetate and what is the scope of freedom to operate?

Ziconotide acetate is the generic ingredient in one branded drug marketed by Tersera and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ziconotide acetate has six patent family members in four countries.

One supplier is listed for this compound.

Summary for ziconotide acetate

International Patents:	6
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	76
What excipients (inactive ingredients) are in ziconotide acetate?	ziconotide acetate excipients list
DailyMed Link:	ziconotide acetate at DailyMed

Pharmacology for ziconotide acetate

Drug Class	N-type Calcium Channel Antagonist
Mechanism of Action	N-Calcium Channel Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ziconotide acetate

N02BG	Other analgesics and antipyretics
N02B	OTHER ANALGESICS AND ANTIPYRETICS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for ziconotide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004		RX	Yes	Yes
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004		RX	Yes	Yes
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004		RX	Yes	Yes
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004		DISCN	No	No

Expired US Patents for ziconotide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004

International Patents for ziconotide acetate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1689401	METHODE DE SOULAGEMENT DE LA DOULEUR (METHOD FOR REDUCING PAIN)
Canada	2540895	METHODE DE SOULAGEMENT DE LA DOULEUR (METHOD FOR REDUCING PAIN)
Japan	2011173931	METHOD FOR REDUCING PAIN
Canada	2930900	METHODE DE REDUCTION DE LA DOULEUR (COMBINATION OF ZICONOTIDE AND OPIOIDS FOR REDUCING PAIN)

Supplementary Protection Certificates for ziconotide acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0835126	SPC/GB05/033	United Kingdom		PRODUCT NAME: ZICONOTIDE, OPTIONALLY IN THE FORM OF A SALT WITH A PHARMACEUTICALLY ACCEPTABLE ACID, INCLUDING ZICONOTIDE ACETATE; REGISTRATION NO/DATE: EU/1/04/302/001 - 003 20050224
0835126	05C0027	France		PRODUCT NAME: ZICONOTIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/302/001 DU 20050221; REGISTRATION NO/DATE AT EEC: EU/1/04/302/001-003 DU 20050221

Ziconotide acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ziconotide Acetate

Introduction

Ziconotide acetate, marketed under the brand name Prialt, is a potent non-opioid analgesic used for the treatment of severe chronic pain in patients who are intolerant or refractory to other treatments, including systemic analgesics and intrathecal morphine. Here, we will delve into the market dynamics and financial trajectory of this medication.

Market Indications and Target Population

Ziconotide is specifically indicated for the treatment of chronic severe pain in patients who have not responded to other analgesic therapies. This includes patients with intractable pain due to cancer and non-malignant conditions, such as failed back surgery syndrome and neuropathic pain[5].

Competitive Landscape

The market for chronic pain management is highly competitive, with various treatments available, including opioids, non-opioid analgesics, and interventional procedures. However, ziconotide stands out as a unique option due to its mechanism of action, which involves binding to N-type calcium channels on nociceptive nerves, providing a non-opioid alternative for severe pain management[4].

Cost-Effectiveness

Studies have shown that ziconotide can be a cost-effective option for patients with severe chronic pain who have failed other treatments. A cost-effectiveness analysis in the UK found that ziconotide had an incremental cost-effectiveness ratio (ICER) of £27,443 per quality-adjusted life-year (QALY) compared to best supportive care. This suggests that while ziconotide is expensive, it can offer significant health benefits that justify its cost[2].

Pricing and Reimbursement

The pricing of ziconotide varies by region and is influenced by factors such as the cost of the drug, the cost of the intrathecal pump system, and healthcare reimbursement policies. In the UK, the cost-effectiveness analysis highlighted that the dosage of ziconotide was a sensitive parameter, with variations in dosage significantly affecting the ICER. This indicates that pricing strategies and reimbursement policies can impact the financial viability of ziconotide treatment[2].

Clinical Efficacy and Patient Outcomes

Clinical trials have demonstrated the efficacy of ziconotide in reducing severe chronic pain. Studies have shown that ziconotide can provide significant pain relief, with a notable improvement in pain scores and quality of life for patients who have failed other treatments. For example, in Study 301, ziconotide showed a 14.7% improvement in VASPI scores compared to a 7.2% improvement with placebo, highlighting its clinical effectiveness[1].

Adverse Effects and Safety Profile

While ziconotide is generally safe and effective, it is associated with several adverse effects, including dizziness, nausea, nystagmus, confusional state, and memory impairment. These side effects are often mild to moderate and resolve over time. However, severe psychiatric symptoms and neurological impairment can occur, necessitating careful patient monitoring[1][5].

Market Penetration and Adoption

The adoption of ziconotide is influenced by several factors, including its efficacy, safety profile, and cost-effectiveness. Despite its benefits, the use of ziconotide is limited by its intrathecal administration requirement, which can be a barrier to adoption. However, for patients with severe refractory pain, ziconotide offers a valuable alternative to traditional treatments.

Financial Performance

The financial performance of ziconotide is tied to its market penetration and the overall demand for chronic pain management solutions. Given its niche market and the specific patient population it targets, ziconotide generates significant revenue despite its limited use compared to broader analgesic markets. The cost-effectiveness studies and positive clinical outcomes support its financial viability in the long term.

Future Outlook

The future outlook for ziconotide is promising, particularly as healthcare systems seek non-opioid alternatives for pain management due to the opioid crisis. As more patients and healthcare providers become aware of ziconotide's benefits, its market share is likely to grow. However, this growth will be influenced by ongoing research, regulatory approvals, and changes in healthcare policies and reimbursement structures.

Regulatory Environment

Ziconotide is subject to strict regulatory oversight due to its potent nature and the potential for severe side effects. The FDA has issued a black-box warning regarding the risk of severe psychiatric symptoms and neurological impairment. Compliance with these regulations and ongoing monitoring of patient outcomes are crucial for maintaining its market presence[5].

Conclusion

Ziconotide acetate is a valuable option for patients with severe chronic pain who have failed other treatments. Its market dynamics are influenced by its unique mechanism of action, cost-effectiveness, and safety profile. While it faces competition in the broader analgesic market, its niche position and the growing need for non-opioid pain management solutions position it for continued financial viability.

Key Takeaways

• Unique Mechanism of Action: Ziconotide binds to N-type calcium channels, offering a non-opioid alternative for severe pain management.
• Cost-Effectiveness: Studies indicate that ziconotide can be cost-effective, especially for patients who have failed other treatments.
• Clinical Efficacy: Ziconotide has shown significant pain relief in clinical trials, improving quality of life for patients with severe chronic pain.
• Safety Profile: While generally safe, ziconotide is associated with several adverse effects, necessitating careful patient monitoring.
• Market Penetration: Adoption is influenced by efficacy, safety, and cost-effectiveness, with potential growth driven by the need for non-opioid pain management solutions.

FAQs

Q: What is the primary indication for ziconotide acetate? A: Ziconotide acetate is indicated for the treatment of chronic severe pain in patients who are intolerant or refractory to systemic analgesics or intrathecal morphine[5].

Q: How is ziconotide administered? A: Ziconotide is administered intrathecally via an implanted pump system, as it does not cross the blood-brain barrier well[5].

Q: What are the common adverse effects of ziconotide? A: Common adverse effects include dizziness, nausea, nystagmus, confusional state, and memory impairment. Severe psychiatric symptoms and neurological impairment can also occur[1][5].

Q: Is ziconotide cost-effective? A: Yes, studies have shown that ziconotide can be cost-effective, particularly for patients who have failed other treatments, with an ICER of £27,443 per QALY compared to best supportive care[2].

Q: What is the regulatory status of ziconotide? A: Ziconotide has an FDA black-box warning regarding the risk of severe psychiatric symptoms and neurological impairment. It is subject to strict regulatory oversight[5].

Sources

1. European Medicines Agency. Prialt, INN-ziconotide - European Medicines Agency.
2. PubMed. Cost-effectiveness of ziconotide in intrathecal pain ... - PubMed.
3. Colorado Department of Labor and Employment. RULE 17, EXHIBIT 9 - Chronic Pain Disorder Medical Treatment ...
4. Drug Central. ziconotide - Drug Central.
5. NCBI Bookshelf. Ziconotide - StatPearls - NCBI Bookshelf.