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PRIALT

NDA

ZICONOTIDE ACETATE | N021060 | ESTEVE PHARMACEUTICALS SA

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from TerSera Therapeutics LLC FDA-2025-P-0334 TerSera Therapeutics LLC, which holds NDA 21060 for PRIALT (ziconotide) solution for intrathecal infusion, filed this citizen petition requesting that the FDA require abbreviated new drug applications and 505(b)(2) applications referencing PRIALT to demonstrate drug-device compatibility with the Med	505(q)	2025-01-24	Open	TerSera Therapeutics LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$582.71

Highest Price

$2925.52

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70720-0720-10PRIALT 100MCG/ML INJ INTRATHECAL	$582.71	Big4	TerSera Therapuetics, LLC	03/14/2029
70720-0720-10PRIALT 100MCG/ML INJ INTRATHECAL	$582.71	FSS	TerSera Therapuetics, LLC	03/14/2029
70720-0722-10PRIALT 100MCG/ML INJ INTRATHECAL	$2923.52	Big4	TerSera Therapuetics, LLC	03/14/2029
70720-0722-10PRIALT 100MCG/ML INJ INTRATHECAL	$2923.52	FSS	TerSera Therapuetics, LLC	03/14/2029
70720-0723-10PRIALT 25MCG/ML INJ INTRATHECAL	$2923.52	Big4	TerSera Therapuetics, LLC	03/14/2029
70720-0723-10PRIALT 25MCG/ML INJ INTRATHECAL	$2925.52	FSS	TerSera Therapuetics, LLC	03/14/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Prialt (2024)

Total Spending

$58K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$747.77

Spending Trend

$85K(2020)→$82K(2021)→$108K(2022)→$99K(2023)→$58K(2024)

YoY Change:+97.0%

5yr CAGR:+46.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Prialt (2024)

Total Spending

$3.6M

Total Claims

1,120

Beneficiaries

322

ASP Price

$9.38

Spending Trend

$5.6M(2019)→$4.9M(2020)→$4.5M(2021)→$4.2M(2022)→$3.7M(2023)→$3.6M(2024)

YoY Change:+3.4%

5yr CAGR:+4.8%

HCPCS: J2278 — Injection, ziconotide, 1 microgram

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHENGDU SHENGNUO BIOPHARM CO LTDZICONOTIDE ACETATE

DMF 331392019

SPECGX LLCInactiveZICONOTIDE (SNX-111), CODE 8068

DMF 101231993

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Sep 6, 2011	SUPPL -6	View Letter (PDF)
Apr 25, 2007	SUPPL -3	View Letter (PDF)
May 27, 2005	SUPPL -1	View Letter (PDF)
Dec 29, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 500MCG/20ML (25MCG/ML)

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRATHECAL | Approved: Dec 28, 2004

No patent or exclusivity listings for this strength.

#002 — 100MCG/1ML (100MCG/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRATHECAL | Approved: Dec 28, 2004

#003 — 200MCG/2ML (100MCG/ML)

0 patents0 exclusivities▾

INJECTABLE;INTRATHECAL | Approved: Dec 28, 2004

#004 — 500MCG/5ML (100MCG/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRATHECAL | Approved: Dec 28, 2004