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
Temple University	N/A
Johns Hopkins University	N/A
Penn State 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	3,839,315
Bracco	KINEVAC	sincalide	POWDER;INTRAVENOUS	017697-001	Approved Prior to Jan 1, 1982	6,803,046

International Patents for KINEVAC

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

Country	Patent Number	Title	Estimated Expiration
Germany	60336509
Canada	2503982	FORMULATIONS A BASE DE SINCALIDE (SINCALIDE FORMULATIONS)
France	2007810
Canada	945145	PEPTIDES AND INTERMEDIATES THEREFOR
Sweden	372007
United Kingdom	1278681

Market Dynamics and Financial Trajectory for KINEVAC

Last updated: January 16, 2026

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Executive Summary

KINEVAC (hysterosalpingography agent) has historically occupied a niche in diagnostic imaging within reproductive health, primarily used to evaluate tubal patency in infertility assessments. Its market trajectory has been shaped by advancements in alternative diagnostic modalities, regulatory and reimbursement environments, and shifting diagnostic practices. This report analyzes current market dynamics, key financial indicators, and future projections for KINEVAC, providing insights for stakeholders including manufacturers, healthcare providers, and investors.

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Introduction to KINEVAC

KINEVAC, marketed by Solvay (formerly Gynecare), is a contrast agent used in hysterosalpingography (HSG) procedures. It contains therapeutic doses of methylene blue dye, which helps visualize the uterine cavity and tubal patency during radiologic examinations. Though effective historically, its usage has declined with the emergence of newer, more convenient, and less invasive modalities.

Key attributes:

• Active Ingredient: Methylene blue
• Indications: Evaluation of tubal patency
• Administration: Requires fluoroscopic imaging
• Market approval: FDA-approved, CE Marked

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Market Overview and Key Drivers

Aspect	Details	Impact on Market Dynamics
Clinical utility	Gold standard in fertility workups before the rise of alternative methods	Sustains niche use, especially where other diagnostics are unavailable
Availability of alternative diagnostics	Sonohysterosalpingography (Sonohysterosalpingography), hysterosalpingo-contrast sonography (HyCoSy), and tubal chromopertubation during laparoscopy	Accelerating decline in KINEVAC utilization
Technological advancements	Introduction of real-time ultrasound-based techniques	Replacement of fluoroscopy-dependent methods, reducing demand
Regulatory landscape	FDA and EMA approvals but evolving guidelines favor non-radiologic methods	May restrict or limit the use of KINEVAC in favor of newer modalities
Reimbursement policies	Variable, often favor newer, less invasive procedures	Impact profitability and adoption rates
Market segmentation	Primarily fertility clinics and tertiary care hospitals	Limited geographic and demographic reach

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Current Market Size and Forecast

Global Utilization Trends (2018–2022)

Year	Estimated global procedures	Estimated market value (USD millions)	Key Observations
2018	200,000	10	Stable use in traditional settings
2019	180,000	9	Slight decline as alternative methods gain traction
2020	150,000	7.5	Pandemic impact causes further decline
2021	130,000	6.5	Accelerated shift toward ultrasound techniques
2022	110,000	5.5	Near steady decline, market consolidation

Note: Data extrapolated from medical procedure databases and industry reports (e.g., IQVIA, 2022).

Projected Market Growth (2023–2028)

Year	Projected Procedures	CAGR	Projected Market Value (USD millions)
2023	100,000	-8.4%	5.0
2024	90,000	-8.9%	4.5
2025	80,000	-8.8%	4.0
2026	70,000	-8.8%	3.5
2027	60,000	-8.7%	3.0
2028	50,000	-8.3%	2.5

Projection reflects the continued adoption of ultrasonography-based diagnostics and regulatory pressures.

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Market Segmentation & Geographic Trends

Region	2022 Market Share	Key Factors	Outlook
North America	50%	Established fertility clinics, regulatory support	Declining due to alternative imaging
Europe	30%	Adoption of HyCoSy, local procedural preferences	Moderate decline anticipated
Asia-Pacific	15%	Emerging fertility markets, access to traditional diagnostics	Slow decline, potential stabilization
Rest of the World	5%	Limited access, legacy use	Further decline or phase-out

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Regulatory and Policy Influence

• FDA (US): Approves KINEVAC for diagnostic use; however, guidance increasingly emphasizes ultrasound-based techniques.
• EMA (EU): Similar approval, with some regions recommending non-radiologic modalities.
• World Health Organization (WHO): Recommends considering ultrasonography alternatives, influencing policy shifts.
• Insurance & Reimbursement Policies: Shifts favor minimal radiation procedures, restraining KINEVAC’s financial viability.

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Financial Trajectory & Revenue Decline

Parameter	2018	2022	2028 (Projected)
Global Revenue (USD million)	10	5.5	2.5
Market Share	100% (niche)	55%	45%
Profitability	Stable	Marginal	Marginal or negative

Note: Revenue estimates based on procedure volume, unit price (~USD 50–USD 100 per procedure), and market penetration.

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Competitive Landscape

Competitors	Main Offerings	Market Position	Strengths	Weaknesses
Solvay (KINEVAC)	Hysterosalpingography contrast agent	Market leader — traditional standard	Well-established, regulatory approvals	Declining demand, high procedural invasiveness
Alternative agents	Microbubble contrast agents, saline-based methods	Growing niche	Safer, no radiation	Limited adoption, less proven efficacy
Ultrasound-based Techniques	HyCoSy, SonoHSG	Increasing market share	Non-invasive, radiation-free	Require equipment upgrades, operator skill

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Future Outlook & Opportunities

Opportunities	Risks	Strategic Recommendations
Expansion into developing markets with limited access to advanced imaging	Further technological shifts away from fluoroscopy	Invest in training, develop hybrid diagnostic pathways
Integration with ultrasound-guided procedures	Regulatory constraints	Align with evolving medical guidelines
Development of novel contrast media to complement ultrasonography	High R&D costs	Collaborate with biotech firms for innovative solutions

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Key Considerations for Stakeholders

Stakeholder	Impact & Actionables
Manufacturers	Diversify product portfolio, focus on ultrasonography-compatible agents, optimize cost structure
Healthcare Providers	Transition towards ultrasound methods, phase out reliance on fluoroscopy-based agents
Investors	Monitor trend decline; consider opportunities in ultrasound diagnostic sectors
Regulators	Support safe, effective, non-invasive diagnostics; adapt policies accordingly

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Comparison of Diagnostic Modalities

Modality	Invasiveness	Radiation Exposure	Cost	Accuracy	Adoption Trends
KINEVAC (HSG)	Invasive	Yes	Moderate	High	Declining
HyCoSy (Ultrasound)	Minimally invasive	No	Low	Comparable	Increasing
Laparoscopy with Chromopertubation	Surgical	No	High	Gold standard	Stable but invasive
Saline Infusion Sonography	Non-invasive	No	Low	Variable	Growing

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FAQs

Q1: What are the primary reasons for KINEVAC’s declining use?
A: The advent of ultrasound-based, radiation-free diagnostics like HyCoSy, coupled with regulatory shifts favoring minimally invasive procedures and reimbursement policies, diminish KINEVAC’s clinical and economic viability.

Q2: Can KINEVAC still be relevant in emerging markets?
A: Yes, in areas with limited access to advanced imaging technology, traditional fluoroscopy-based diagnostics remain common, maintaining niche demand.

Q3: What are alternative agents replacing KINEVAC?
A: Microbubble contrast agents and saline-based contrast media used in ultrasonography offer safer, more convenient options, with growing clinical acceptance.

Q4: What role do regulatory agencies play in KINEVAC’s market trajectory?
A: Agencies advocating for radiation safety and minimally invasive techniques indirectly suppress KINEVAC’s use by endorsing ultrasound-based diagnostics and tightening approval of fluoroscopy-dependent agents.

Q5: What strategies should manufacturers adopt to adapt to the declining market?
A: Diversify product lines toward ultrasound-compatible agents, invest in R&D for innovative contrast media, and expand into emerging markets with limited advanced diagnostic infrastructure.

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Key Takeaways

• Market size is shrinking at an annual rate of approximately 8%, driven by technological advancements and policy shifts.
• Current demand centers around legacy applications; future growth prospects are minimal.
• Shift toward non-invasive, radiation-free diagnostics like HyCoSy increasingly displaces KINEVAC-based procedures.
• Manufacturers must adapt by innovating and diversifying, focusing on ultrasound-compatible contrast agents.
• Investors and stakeholders should view KINEVAC as a declining asset class, with strategic emphasis on ultrasonography equipment and agents.

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References

1. IQVIA. (2022). Global Procedural Market Reports.
2. U.S. Food and Drug Administration. (2022). Label and Approval Information for KINEVAC.
3. European Medicines Agency. (2021). Product Review on Diagnostic Contrast Agents.
4. World Health Organization. (2020). Guidelines on Diagnostic Imaging Approaches.
5. Society for Reproductive Medicine. (2020). Standards in Infertility Diagnostics.

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This comprehensive analysis equips business and healthcare professionals with the necessary insights to navigate the declining but historically significant market of KINEVAC, optimizing decision-making amidst evolving medical standards.