KINEVAC Drug Patent Profile

When do Kinevac patents expire, and when can generic versions of Kinevac launch?

Kinevac is a drug marketed by Bracco and is included in one NDA. There is one patent protecting this drug.

This drug has ten patent family members in eight countries.

The generic ingredient in KINEVAC is sincalide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sincalide profile page.

DrugPatentWatch^® Generic Entry Outlook for Kinevac

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 16, 2022. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for KINEVAC

International Patents:	10
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	1
Patent Applications:	1,969
Drug Prices:	Drug price information for KINEVAC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KINEVAC
What excipients (inactive ingredients) are in KINEVAC?	KINEVAC excipients list
DailyMed Link:	KINEVAC at DailyMed

See drug prices for KINEVAC

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for KINEVAC

NDA:

017697

Dosage:

INJECTABLE;INJECTION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for KINEVAC

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

Sponsor	Phase
Penn State University	N/A
Memorial Health University Medical Center	N/A
Temple University	N/A

See all KINEVAC clinical trials

Pharmacology for KINEVAC

Drug Class

Cholecystokinin Analog

Anatomical Therapeutic Chemical (ATC) Classes for KINEVAC

V04CC	Tests for bile duct patency
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for KINEVAC

KINEVAC is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting KINEVAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	KINEVAC	sincalide	INJECTABLE;INJECTION	017697-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes			Y

Expired US Patents for KINEVAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	KINEVAC	sincalide	INJECTABLE;INJECTION	017697-001	Approved Prior to Jan 1, 1982

International Patents for KINEVAC

When does loss-of-exclusivity occur for KINEVAC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Canada

China

European Patent Office

Germany

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KINEVAC around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4751993
China	100374154
France	2007810
Canada	2503982	FORMULATIONS A BASE DE SINCALIDE (SINCALIDE FORMULATIONS)
Switzerland	517702	Procédé de préparation de nouveaux peptides