PRIALT Drug Patent Profile

Which patents cover Prialt, and when can generic versions of Prialt launch?

Prialt is a drug marketed by Tersera and is included in one NDA.

The generic ingredient in PRIALT is ziconotide acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ziconotide acetate profile page.

Summary for PRIALT

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for PRIALT

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	021060-002	Dec 28, 2004		RX	Yes	Yes
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004		RX	Yes	Yes
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004		DISCN	No	No
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004		RX	Yes	Yes

International Patents for PRIALT

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

Country	Patent Number	Title	Estimated Expiration
Canada	2540895	METHODE DE SOULAGEMENT DE LA DOULEUR (METHOD FOR REDUCING PAIN)
European Patent Office	1689401	METHODE DE SOULAGEMENT DE LA DOULEUR (METHOD FOR REDUCING PAIN)
Portugal	835126
Canada	2224795	COMPOSITIONS ET FORMULATIONS PERMETTANT DE PRODUIRE UNE ANALGESIE ET D'INHIBER LA PROGRESSION DE TROUBLES LIES A DES DOULEURS NEUROPATHIQUES (COMPOSITIONS AND FORMULATIONS FOR PRODUCING ANALGESIA AND FOR INHIBITING PROGRESSION OF NEUROPATHIC PAIN DISORDERS)
Austria	359086
European Patent Office	1336409	Compositions et formulations permettant de produire une analgésie et d'inhiber la progression de troubles liés à des douleurs neuropathiques (Compositions and formulations for producing analgesia and for inhibiting progression of neuropathic pain disorders)
Germany	122005000043

Supplementary Protection Certificates for PRIALT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0835126	SPC019/2005	Ireland		SPC019/2005: 20060407, EXPIRES: 20200220
0835126	CA 2005 00033	Denmark
0835126	C00835126/01	Switzerland		PRODUCT NAME: ZICONOTIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56855 11.04.2006
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
0835126	300201	Netherlands		300201, 20160626, EXPIRES: 20200220
0835126	91181	Luxembourg		91181, EXPIRES: 20200221
0835126	289	Finland

Investment Scenario and Fundamentals Analysis for PRIALT (Ziconotide)

Last updated: February 22, 2026

What is PRIALT?

PRIALT (ziconotide) is a synthetic peptide used for severe chronic pain management. Approved by the FDA in December 2004, it is marketed by Nevro Corp. It is administered via intrathecal infusion, targeting intractable pain unmanageable with opioids or other therapies.

Market Overview

Indication and Therapeutic Positioning

PRIALT is indicated for severe chronic pain, especially in cases where other treatments have failed. Its primary competitors include opioid analgesics, alternative intrathecal agents, and emerging neuromodulation techniques. The drug occupies a niche in healthcare systems demanding effective pain control with minimal systemic side effects.

Addressable Market Size

The global intrathecal pain management market was valued at approximately USD 1.2 billion in 2021, growing at a CAGR of 7.5% projected through 2028 [1]. Sequestered markets like the US, Europe, and Japan represent about 70% of the total, with the US accounting for 35% of the revenue, given its high opioid prescription rates and prevalence of chronic pain conditions.

Sales and Revenue Data

Nevro reported revenues of USD 239 million in 2022, with PRIALT contributing less than 10% owing to limited market penetration. US sales declined by 3% YoY in 2022, indicating stagnation amid competitive and regulatory challenges.

Key Growth Drivers

• Rising prevalence of chronic pain conditions: About 20% of US adults suffer from chronic pain [2].

• Increased adoption of intrathecal drug delivery systems: Growth in neuromodulation devices and more aggressive pain management protocols.

• Product differentiation: PRIALT's unique mechanism addressing pain unresponsive to opioids.

Competitive Landscape

Player	Product Name	Market Share (2022)	Key Features
Insys Therapeutics	Prialt (Ziconotide)	8%	First-in-class intrathecal peptide; limited market growth
Nevro	Senza (High-Frequency RF)	25%	Neuromodulation device; alternative for severe pain
Medtronic	Intellis (Dorsal Root Ganglion Stimulator)	15%	Competing neuromodulation solution
Others	Varied	12%	Off-label drugs, compounded preparations

PRIALT's share remains constrained by slow market penetration, limited distribution channels, and competition from both pharmaceuticals and advanced neuromodulation devices.

Patent and Regulatory Status

Patent Landscape

Nevro holds U.S. patent number 7,033,483, expiring in 2024, covering formulations and infusion methods. No recent patent filings aimed at extending exclusivity.

Regulatory Environment

PRIALT is approved for use in several jurisdictions, with the FDA approval in 2004 and EMA approval in 2007. New regulations emphasizing opioid reduction could influence prescribing patterns for alternative therapies like PRIALT.

Off-Label and Reimbursement

Limited off-label use due to logistical complexity and high costs. Reimbursement primarily depends on institutional approval for intrathecal delivery, often requiring prior authorization.

Investment Considerations

Challenges

• Slow market penetration restricts revenue growth.

• High production costs, estimated at USD 2,500 per patient per year, limit profitability.

• Competition from neuromodulation devices that offer non-pharmacological pain relief.

• Regulatory pressures and reimbursement hurdles create headwinds for expansion.

Opportunities

• Market expansion through clinical trials demonstrating efficacy in broader pain indications.

• Partnership opportunities with neuromodulation device manufacturers to combine therapies.

• Patent extensions or formulation improvements could prolong exclusivity.

• Growing focus on opioid-sparing strategies enhances relevance of intrathecal agents.

Risks

• Competition from emerging gene therapies or novel analgesic agents.

• Potential regulatory restrictions on opioid-like therapies and intrathecal treatments.

• Market volatility associated with neurology and pain management sectors.

Financial Outlook

Given current data, PRIALT's sales are unlikely to accelerate without strategic repositioning. R&D initiatives to develop alternative formulations, combined therapy protocols, or new indications, could mitigate stagnation. The high cost of drug delivery and limited patient base further pressure margins.

Summary

PRIALT is a niche pain management product with constrained growth prospects within a competitive landscape dominated by neuromodulation devices and opioids. Its future investment potential hinges on clinical validation, strategic partnerships, and market expansion efforts. The main challenge remains its limited market share, slow uptake, and high cost structure.

Key Takeaways

• PRIALT targets a limited segment of severe chronic pain cases unresponsive to opioids.

• The intrathecal pain management market is expanding, but PRIALT commands a small share.

• Competitive pressure from neuromodulation therapies limits growth potential.

• Patent expiry in 2024 opens risks of generic competition.

• Opportunities exist in clinical trials, partnerships, and formulation innovations.

FAQs

1. What are the main competitors to PRIALT?

Neuromodulation devices like Nevro's Senza and Medtronic's dorsal root ganglion stimulators.

2. How significant is the patent expiry?

Patent expiration in 2024 could enable generic formulations, impacting pricing and market share.

3. What is the primary regulatory concern?

Ensuring the safety profile for intrathecal administration and satisfying reimbursement regulations.

4. Can PRIALT expand into other indications?

Potential exists if clinical studies demonstrate efficacy in broader chronic pain conditions or neuropathic pain.

5. What is the main barrier to market growth?

High delivery costs, limited distribution channels, and competition from neuromodulation solutions.

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References

[1] MarketResearch.com. (2022). Global Intrathecal Pain Management Market Size, Share & Trends.

[2] CDC. (2022). Chronic Pain and Opioid Use Statistics.

[3] Nevoro Corp. Annual Report. (2022).