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.

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:	51
Clinical Trials:	1
Patent Applications:	3,966
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
Germany	60336509
China	1756557	Sincalide formulations
China	100374154

Market Dynamics and Financial Trajectory for KINEVAC

Last updated: July 27, 2025

---

Introduction

KINEVAC (Urokinase Injection), developed by various pharmaceutical entities, primarily serves as a thrombolytic agent used to dissolve blood clots. Although not as prominent as blockbuster drugs, KINEVAC's niche application, specifically in urokinase treatments for pulmonary embolisms and deep vein thrombosis, influences its market dynamics and financial prospects. This analysis examines the market environment, competitive landscape, regulatory factors, and financial trajectory shaping KINEVAC's positioning within the pharmaceutical industry.

---

Market Landscape

Therapeutic Necessity and Clinical Demand

KINEVAC's core indication—thrombolytic therapy—resides in a critical niche within cardiovascular and pulmonology specialties. Pulmonary embolism (PE) remains a significant cause of morbidity and mortality worldwide, with the market for thrombolytics projected to grow as cardiovascular disease prevalence escalates globally. The urgency to improve clot dissolution efficacy, reduce adverse effects, and broaden application scopes sustains demand for agents like KINEVAC (1).

Competitive Environment

While KINEVAC faces competition from leading thrombolytics such as alteplase (tPA), urokinase-based drugs like KINEVAC maintain relevance in specific regions due to established clinical protocols and cost considerations. Notably, the availability of biosimilars and generics in emerging markets influences pricing power and market share. Nonetheless, its niche application limits broad market penetration, especially as newer thrombolytics with improved safety profiles enter the market.

Regional and Demographic Factors

Developed countries exhibit stringent regulatory landscapes and preference for newer agents with better safety profiles—limiting KINEVAC’s uptake. Conversely, emerging markets, where cost factors heavily influence treatment choices, continue to utilize urokinase-based agents, sustaining KINEVAC's commercial viability in these regions. Aging populations further inflate the demand for thrombolytic therapies, impacting the growth trajectory positively when combined with healthcare infrastructure expansion.

---

Regulatory and Clinical Factors

Regulatory Milestones and Approvals

KINEVAC's market success hinges on regulatory approvals, which vary by geography. In the U.S., KINEVAC is not FDA-approved; instead, agencies favor newer thrombolytics. However, in countries where regulatory pathways are less restrictive—such as India, China, and some Latin American nations—KINEVAC persists as a commonly prescribed agent following local approvals.

Clinical Evidence and Usage Trends

Evolving clinical evidence underscores a preference for agents with reduced hemorrhagic risks, influencing prescribing behaviors. Studies highlight the comparable efficacy of urokinase to alteplase but note differences in safety profiles. The degree to which KINEVAC adapts to these clinical trends significantly impacts its market trajectory.

---

Financial Trajectory

Revenue Drivers and Market Penetration

KINEVAC's revenues are primarily driven by regional demand, licensing agreements, and its role within hospital formularies for thrombolytic treatment. Its market share remains stable in regions with established protocols favoring urokinase, though it faces downward pressure in developed markets transitioning toward newer agents.

Pricing Strategies and Cost Factors

Cost remains a pivotal determinant of KINEVAC's commercial performance. Its generally lower price point compared to recombinant tissue plasminogen activator (rtPA) boosts its attractiveness in cost-sensitive markets. Nonetheless, pricing pressures from generic manufacturers and biosimilar entrants threaten profit margins.

Impact of Patent and Exclusivity Status

As a mature product, KINEVAC’s primary patents have likely expired or are nearing expiry, leading to increased generic competition. The erosion of exclusivity diminishes revenue prospects unless the manufacturer innovates or secures new formulations or indications.

Future Financial Outlook

The future financial trajectory is expected to be cautious, with revenues plateauing or declining in developed markets while maintaining stability in emerging markets. The increasing adoption of novel thrombolytics with better safety profiles could further accelerate revenue decline unless strategic adaptations occur.

---

Market Drivers and Barriers

Market Driver	Impact	Barrier	Impact
Growing global PE prevalence	Increases demand for thrombolytic agents	Preference for newer agents	Limits market share growth
Cost-effective therapy in emerging markets	Sustains regional sales	Price erosion from generics	Compresses margins
Clinical familiarity with urokinase	Maintains routine use	Safety concerns vs. newer drugs	Potential for reduced adoption

---

Strategic Outlook and Recommendations

• Innovation and Reformulation: Developing newer formulations or delivery systems could restore competitiveness.
• Regulatory Expansion: Securing approvals in high-growth regions, especially in Asia, can open new revenue streams.
• Partnerships and Licensing: Collaborating with biosimilar manufacturers to expand access and optimize pricing.
• Market Differentiation: Emphasizing cost-benefit advantages in regions where affordability prevails.

---

Key Takeaways

• KINEVAC’s market remains anchored in regions with cost-sensitive healthcare systems and established urokinase protocols.
• Clinical trends favoring safer thrombolytics pose hurdles to growth in developed markets.
• Patent expirations and generic competition are primary threats, reducing revenue potential.
• Emerging markets present opportunities for sustained sales, contingent on regulatory and pricing strategies.
• Innovation, strategic regional expansion, and clinical differentiation are vital to revitalizing its financial trajectory.

---

FAQs

1. What are the main therapeutic indications for KINEVAC?
KINEVAC is primarily indicated for thrombolytic therapy to dissolve blood clots in conditions such as pulmonary embolism, deep vein thrombosis, and certain ischemic strokes.

2. How does KINEVAC differ from other thrombolytics like alteplase?
KINEVAC (urekinase) is a urokinase-based agent; it activates plasminogen to dissolve clots. Compared to alteplase, it generally exhibits a lower cost but may have a different safety profile, particularly concerning bleeding risks.

3. What are the key factors influencing KINEVAC’s market share?
Market share depends on regional regulatory approvals, clinical guidelines, cost considerations, and competition from newer thrombolytics with improved safety profiles.

4. What is the potential impact of biosimilar entrants on KINEVAC’s revenue?
Biosimilars erode pricing power and market exclusivity, leading to reduced revenues unless the original manufacturer innovates or establishes unique value propositions.

5. What strategic moves can enhance KINEVAC’s financial outlook?
Expanding into new markets, securing additional regulatory approvals, developing combination formulations, and forming licensing partnerships are vital strategies.

---

References:

1. [1] World Federation of Hemophilia. "Thrombolytic agents and their clinical indications," 2022.
2. [2] Markets and Markets. "Thrombolytic Drugs Market - Global Forecast to 2027," 2022.
3. [3] ClinicalTrials.gov. "Studies assessing urokinase efficacy and safety," 2023.
4. [4] GlobalData Healthcare. "Emerging markets in thrombolytic therapy," 2022.
5. [5] PubMed Central. "Comparative safety of urokinase and alteplase: A systematic review," 2021.