Viewing data from:

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Prialt (2023)

Total Spending

$99K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$379.49

Spending Trend

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

YoY Change:+51.4%

5yr CAGR:+32.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Prialt (2023)

Total Spending

$3.7M

Total Claims

1,086

Beneficiaries

314

ASP Price

—

HCPCS: J2278 — Injection, ziconotide, 1 microgram

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain1 active DMF

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

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