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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	6
Patent Applications:	1,219
Drug Prices:	Drug price information for PRIALT
What excipients (inactive ingredients) are in PRIALT?	PRIALT excipients list
DailyMed Link:	PRIALT at DailyMed

See drug prices for PRIALT

Recent Clinical Trials for PRIALT

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

Sponsor	Phase
Albany Medical College	Phase 4
Aaron Boster	Phase 4
Jazz Pharmaceuticals

See all PRIALT clinical trials

Pharmacology for PRIALT

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

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

Expired US Patents for PRIALT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004	5,859,186
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004	8,765,680
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-003	Dec 28, 2004	5,364,842
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004	8,765,680
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-004	Dec 28, 2004	5,795,864
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-002	Dec 28, 2004	5,364,842
Tersera	PRIALT	ziconotide acetate	INJECTABLE;INTRATHECAL	021060-001	Dec 28, 2004	9,707,270

International Patents for PRIALT

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

Country	Patent Number	Title	Estimated Expiration
Australia	6400296
Canada	2151741	METHODE ANALGESIQUE ET AMELIORATION D'UNE METHODE ANALGESIQUE UTILISANT UN OPIACE (METHODS OF PRODUCING ANALGESIA AND ENHANCING OPIATE ANALGESIA)
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)
European Patent Office	0835126	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)
Japan	2838073
Portugal	835126
Spain	2194998

Supplementary Protection Certificates for PRIALT

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

Market Dynamics and Financial Trajectory for Prialt (Ziconotide Intrathecal Infusion)

Introduction

Prialt, also known as ziconotide intrathecal infusion, is a potent non-opioid analgesic used for the management of severe chronic pain in patients who are intolerant of or refractory to other treatments. Here, we will delve into the market dynamics and financial trajectory of Prialt, exploring its approval, usage, financial performance, and the impact of patent expiration.

Approval and Indication

Prialt was approved by the FDA in 2004 for the management of severe chronic pain in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatments. It is administered via intrathecal infusion and works by selectively blocking N-type calcium channels to inhibit pain signaling at the spinal cord level[4].

Market Position

Prialt is a niche product targeting a specific patient population with severe chronic pain. Its market position is unique due to its mechanism of action and the specific patient group it serves. However, this also means it operates in a relatively small market segment compared to broader pain management therapies.

Financial Performance

Historically, Prialt has contributed to the revenue of its manufacturer, Jazz Pharmaceuticals. In 2018, Jazz Pharmaceuticals reported that Prialt generated $20.839 million in net product sales, which was a decline from the previous year's $27.361 million. This decline could be attributed to various factors, including competition from other pain management options and changes in market dynamics[2].

Sale of Rights

In the third quarter of 2018, Jazz Pharmaceuticals completed the sale of its rights to Prialt. This transaction likely impacted the financial trajectory of the drug, as the new owner would assume all associated revenues and expenses. The sale was part of Jazz Pharmaceuticals' strategic restructuring to focus on other product lines and development programs[2].

Patent Expiration

One of the critical factors influencing the financial trajectory of Prialt is the expiration of its patent. According to recent reports, the patent for Prialt is set to expire on October 1, 2024. Patent expiration typically leads to a significant decrease in drug prices due to the entry of generic competitors into the market. Studies have shown that drug prices can decrease by as much as 50-80% after patent expiration, depending on the country and market conditions[5].

Impact of Patent Expiration

The expiration of Prialt's patent will likely lead to several outcomes:

• Price Reduction: Generic versions of ziconotide will enter the market, leading to a substantial reduction in prices. This can make the drug more accessible to patients but will also reduce the revenue generated by the brand-name product.
• Market Share: The entry of generics may erode the market share of the brand-name Prialt, as healthcare providers and patients opt for the more affordable generic alternatives.
• Revenue Decline: The financial performance of Prialt will likely decline post-patent expiration, as the brand-name product faces increased competition from generics.

Economic Implications

The shift towards generic competition changes the economic landscape for Prialt. Here are some key economic implications:

• Pricing Strategy: The ability to predict a drug's market performance and pricing strategy changes significantly after patent expiration. Companies must adjust their pricing models to remain competitive in a market with generic alternatives[3].
• Cost-Effectiveness: The introduction of generics can significantly impact cost-effectiveness analyses. Generic drugs are generally more cost-effective, which can influence healthcare policy and reimbursement decisions[5].

Clinical and Market Relevance

Despite the impending patent expiration, Prialt remains a clinically relevant option for severe chronic pain management. Its unique mechanism of action and efficacy in a specific patient population ensure it will continue to be used, albeit potentially at a lower price point.

Clinical Trials and Development

Prialt has undergone extensive clinical trials to establish its efficacy and safety. The drug has been studied in several pivotal phase 3 trials, which have supported its FDA approval and continued use in clinical practice[4].

Conclusion

Prialt, as a niche product in the pain management market, has a distinct financial trajectory influenced by its patent status, market dynamics, and clinical relevance. As the patent expires, the drug will face significant changes, including price reductions and potential market share erosion. However, its unique mechanism of action ensures it will remain a valuable option for patients with severe chronic pain.

Key Takeaways

• Patent Expiration: Prialt's patent is set to expire on October 1, 2024, which will lead to the entry of generic competitors.
• Price Reduction: Generic competition will result in significant price reductions, making the drug more accessible but reducing revenue.
• Market Share: The brand-name product will likely lose market share to generic alternatives.
• Clinical Relevance: Despite patent expiration, Prialt remains clinically relevant for severe chronic pain management.
• Economic Implications: Changes in pricing strategy and cost-effectiveness analyses will be necessary post-patent expiration.

FAQs

What is Prialt used for?

Prialt (ziconotide intrathecal infusion) is used for the management of severe chronic pain in patients who are intolerant of or refractory to other treatments.

When was Prialt approved by the FDA?

Prialt was approved by the FDA in 2004.

What is the mechanism of action of Prialt?

Prialt works by selectively blocking N-type calcium channels to inhibit pain signaling at the spinal cord level.

What is the impact of patent expiration on Prialt?

The expiration of Prialt's patent will lead to the entry of generic competitors, resulting in significant price reductions and potential market share erosion for the brand-name product.

How does the sale of rights to Prialt affect its financial trajectory?

The sale of rights to Prialt in 2018 transferred the associated revenues and expenses to the new owner, impacting the financial performance and strategic focus of the original manufacturer, Jazz Pharmaceuticals.