KINEVAC Drug Patent Profile

Which patents cover Kinevac, and when can generic versions of Kinevac launch?

Kinevac is a drug marketed by Bracco and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kinevac

A generic version of KINEVAC was approved as sincalide by MAIA PHARMS INC on November 22^nd, 2022.

Summary for KINEVAC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	1
Patent Applications:	1,506
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

Recent Clinical Trials for KINEVAC

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

Sponsor	Phase
Memorial Health University Medical Center	N/A
Temple University	N/A
Johns Hopkins University	N/A

See all KINEVAC clinical trials

Pharmacology for KINEVAC

Drug Class

Cholecystokinin Analog

US Patents and Regulatory Information for 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	POWDER;INTRAVENOUS	017697-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes

Expired US Patents for KINEVAC

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

International Patents for KINEVAC

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

Country	Patent Number	Title	Estimated Expiration
Denmark	132074
Sweden	372007
China	100374154
Austria	502647

KINEVAC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Kinevac (Sincalide for Injection)

Introduction

Kinevac, also known as sincalide, is a diagnostic pharmaceutical agent used to stimulate gallbladder contraction, pancreatic secretion, and to accelerate the transit of a barium meal through the small bowel. Here, we will delve into the market dynamics and financial trajectory of Kinevac.

Indications and Usage

Kinevac is indicated in adults for several key diagnostic purposes:

• To stimulate gallbladder contraction, which can be assessed through various diagnostic imaging methods[2][3][5].
• To stimulate pancreatic secretion.
• To accelerate the transit of a barium meal through the small bowel, reducing the time and radiation exposure during fluoroscopy and X-ray examinations.

Market Supply and Manufacturing

Historically, Kinevac faced supply chain issues due to the closure of the manufacturing facility of its original manufacturer, BMSqiubb. To address this, Bracco Diagnostics Inc. reformulated Kinevac and shifted its manufacturing to Ben Venue Laboratories in Bedford, OH[1].

Recently, Fresenius Kabi has launched an authorized generic version of Kinevac, further expanding the supply chain. This generic version is therapeutically equivalent and fully substitutable to Bracco Diagnostics Inc.’s Kinevac, providing healthcare facilities with additional options[3].

Competitive Landscape

The introduction of Fresenius Kabi's authorized generic version of Kinevac has broadened the competitive landscape. While there is no fully generic version of Kinevac approved in the U.S. as of the latest updates, the authorized generic by Fresenius Kabi offers a significant alternative[4].

Market Impact

The entry of Fresenius Kabi into the market with an authorized generic has several implications:

• Increased Competition: The presence of an authorized generic can lead to competitive pricing, potentially reducing the market share of the branded version.
• Improved Supply Chain: Fresenius Kabi's investment in advanced manufacturing and distribution networks in the U.S. enhances the reliability of the drug's supply[3].

Financial Trajectory

Revenue and Sales

The financial performance of Kinevac is influenced by its diagnostic utility and market demand. Given its critical role in radiology and gastrointestinal diagnostics, Kinevac has maintained a stable market presence. However, the introduction of an authorized generic could impact revenue by offering a cost-effective alternative.

Pricing and Cost

The pricing of Kinevac and its generic counterpart can significantly affect its financial trajectory. Authorized generics, like the one from Fresenius Kabi, are often priced lower than the branded version, which could lead to a shift in market share and revenue distribution.

Investment and Manufacturing Costs

Bracco Diagnostics Inc. and Fresenius Kabi have invested significantly in manufacturing and distribution. For instance, Fresenius Kabi has invested nearly $1 billion in its U.S. manufacturing and distribution network, indicating a long-term commitment to the market[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Kinevac:

• FDA Approvals: The FDA's approval of the reformulated Kinevac and the authorized generic by Fresenius Kabi ensures compliance with safety and efficacy standards[1][3].
• Patent and Exclusivity: The absence of a fully generic version is partly due to patent and exclusivity rights. Bracco Diagnostics Inc. holds the rights to Kinevac, and any generic version must be authorized or wait for the expiration of these rights[4].

Safety and Adverse Reactions

The safety profile of Kinevac is another factor influencing its market dynamics. Common adverse reactions include gastrointestinal symptoms like nausea, vomiting, and abdominal pain, as well as potential serious hypersensitivity reactions and effects on pregnant patients[2].

Market Demand and Growth Prospects

The demand for diagnostic agents like Kinevac is driven by the need for accurate and efficient diagnostic tools in radiology and gastroenterology. With the aging population and increasing prevalence of gastrointestinal disorders, the demand for Kinevac and its generic counterparts is likely to remain stable or grow.

Statistics and Trends

• Usage in Diagnostic Procedures: Kinevac is widely used in diagnostic imaging procedures, which are increasingly common due to advancements in medical technology and the growing need for precise diagnoses.
• Market Expansion: The entry of Fresenius Kabi into the market with an authorized generic has expanded the availability of sincalide, potentially increasing overall market size.

"Diagnostic pharmaceutical agents like Sincalide play a critical role in patient diagnosis, and Fresenius Kabi’s addition of Sincalide provides health care facilities nationwide with new options to ensure timely patient care," said John Ducker, president and CEO of Fresenius Kabi USA[3].

Key Takeaways

• Market Competition: The introduction of an authorized generic by Fresenius Kabi has increased competition in the market.
• Supply Chain Stability: Investments by Bracco Diagnostics Inc. and Fresenius Kabi have improved the supply chain reliability.
• Regulatory Compliance: FDA approvals and regulatory compliance are crucial for maintaining market presence.
• Safety Profile: The drug's safety profile, including potential adverse reactions, influences its usage and market dynamics.
• Market Demand: The demand for Kinevac is driven by the need for diagnostic tools in radiology and gastroenterology.

FAQs

What is Kinevac used for?

Kinevac is used to stimulate gallbladder contraction, pancreatic secretion, and to accelerate the transit of a barium meal through the small bowel during diagnostic imaging procedures.

Who manufactures Kinevac?

Kinevac is manufactured by Bracco Diagnostics Inc., with a recent authorized generic version introduced by Fresenius Kabi.

What are the common adverse reactions of Kinevac?

Common adverse reactions include gastrointestinal symptoms like nausea, vomiting, and abdominal pain, as well as potential serious hypersensitivity reactions.

Is there a generic version of Kinevac available?

As of the latest updates, there is no fully generic version of Kinevac available, but Fresenius Kabi has introduced an authorized generic version.

How does the introduction of an authorized generic affect the market?

The introduction of an authorized generic by Fresenius Kabi increases competition, potentially reducing the market share of the branded version and offering healthcare facilities more options.

Sources

1. FDA: NDA 017697-S012 | FDA
2. Bracco: Kinevac | Bracco
3. Biospace: Fresenius Kabi Broadens Radiology Portfolio with its First-to-Market Authorized Generic Sincalide for Injection
4. Drugs.com: Generic Kinevac Availability - Drugs.com
5. Bracco: Kinevac | Bracco