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KINEVAC

NDA

SINCALIDE | N017697 | BRACCO DIAGNOSTICS INC

1 strength0 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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Bracco Diagnostics Inc FDA-2017-P-6805 · 4 docket documents Bracco Diagnostics Inc. submitted this citizen petition on December 8, 2017, requesting that the FDA determine that the discontinued two-ingredient formulation of KINEVAC for injection was withdrawn for safety and efficacy reasons and should not be used as a reference listed drug for any Abbreviated	505(q)	2017-12-12	Open	Bracco Diagnostics Inc
Citizen Petition from Greenberg Traurig LLP ( on behalf of Bracco Diagnostics... FDA-2017-P-6649 · 4 docket documents Greenberg Traurig LLP, on behalf of Bracco Diagnostics Inc., filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine the two-ingredient formulation of KINEVAC for injection was discontinued for safety and efficacy reasons due to	505(q)	2017-11-29	Withdrawn	Bracco Diagnostics Inc

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

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)NCT00706381	Phase 3	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	31	2008-06-23 → 2012-08-21
Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis NCT00004414	N/A	Completed	University of Michigan	252	1997-09 → 2002-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (2 FSS, 1 Big4)

Lowest Price

$539.10

Highest Price

$1185.13

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
63323-0579-05SINCALIDE 5MCG/VIL INJ	$1185.13	FSS	Fresenius Kabi, LLC	05/14/2030
63323-0579-05SINCALIDE 5MCG/VIL INJ	$539.10	Big4	Fresenius Kabi, LLC	05/14/2030
00270-0556-15KINEVAC 5MCG/VIL INJ LYOPHILIZED	$881.89	FSS	Bracco Diagnostics, Inc.	04/15/2026

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

Medicare Part B Spending

CMS physician-administered drug spending for Kinevac (2024)

Total Spending

$424K

Total Claims

3,417

Beneficiaries

3,409

ASP Price

$132.25

Spending Trend

$627K(2019)→$584K(2020)→$484K(2021)→$373K(2022)→$485K(2023)→$424K(2024)

YoY Change:+4.0%

5yr CAGR:+3.7%

HCPCS: J2805 — Injection, sincalide, 5 micrograms

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

API Supply Chain5 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

BACHEM AGSINCALIDE

DMF 151652000

MATRIX PHARMACORP PRIVATE LTDSINCALIDE

DMF 323022018

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSincalide

DMF 342022019

MSN LIFE SCIENCES PRIVATE LTDSINCALIDE

DMF 364292021

SUN PHARMACEUTICAL INDUSTRIES LTDSINCALIDE

DMF 408752025

BACHEM AMERICAS INCInactiveSINCALIDE

DMF 304312016

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Oct 18, 2023	SUPPL -38	View Letter (PDF)
Dec 21, 2018	SUPPL -33	View Letter (PDF)
Mar 22, 2018	SUPPL -32	View Letter (PDF)
Feb 9, 2018	SUPPL -31	View Letter (PDF)
Apr 28, 2005	SUPPL -17	View Letter (PDF)
Jun 7, 2004	SUPPL -12	View Letter (PDF)
Jun 7, 2004	SUPPL -13	View Letter (PDF)
Jun 7, 2004	SUPPL -15	View Letter (PDF)
Jun 7, 2004	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.005MG/VIAL

RLDAP

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.