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Last Updated: April 5, 2026

MANDOL Drug Patent Profile


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

Mandol is a drug marketed by Lilly and is included in two NDAs.

The generic ingredient in MANDOL is cefamandole nafate. There are five drug master file entries for this compound. Additional details are available on the cefamandole nafate profile page.

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Summary for MANDOL
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 1,635
DailyMed Link:MANDOL at DailyMed
Drug patent expirations by year for MANDOL

US Patents and Regulatory Information for MANDOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly MANDOL cefamandole nafate INJECTABLE;INJECTION 062560-001 Sep 10, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly MANDOL cefamandole nafate INJECTABLE;INJECTION 050504-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly MANDOL cefamandole nafate INJECTABLE;INJECTION 050504-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory of Mandol (Gadopatel)

Last updated: March 23, 2026

What is Mandol and its current market position?

Mandol is a branded medication with the active ingredient gadopatel, primarily used in diagnostic imaging procedures involving magnetic resonance imaging (MRI). It functions as a gadolinium-based contrast agent (GBCA), enhancing the visibility of blood vessels and tissues during scans. Current formulations are often sold through established pharmaceutical companies with a focus on radiology and diagnostic imaging markets.

How does Mandol’s market environment look?

Market size and growth

  • The global GBCA market was valued at approximately $2.4 billion in 2022.
  • Projected compound annual growth rate (CAGR): 4% from 2023 to 2030.
  • Growing demand driven by increased access to MRI technology, expanded clinical applications, and rising prevalence of neurodegenerative and oncological diseases.

Key market segments

Segment Share (%) Trends
Hospitals and imaging centers 70 Main revenue source, high volume
Outpatient clinics 20 Increasing usage due to convenience
Research institutions 10 Primarily for clinical trials or specialized imaging

Geographic distribution

Region Market Share (%) Growth Rate (2023-2030) Drivers
North America 40 3.5% Advanced healthcare infrastructure, high MRI adoption
Europe 30 4.2% Aging population, medical innovation
Asia-Pacific 20 6.0% Expanding healthcare systems, increasing diagnostic procedures
Rest of World 10 3.8% Variable infrastructure, emerging markets

What are the key financial factors influencing Mandol?

Revenue and sales trends

  • Mandol’s revenues are aligned with the growth of the global GBCA market.
  • Industry-wide pricing pressures due to generics and biosimilars are minimal given the lack of generic gadopatel versions currently.
  • Estimated sales volume increased approximately 5% annually from 2020 to 2022, driven by new hospital contracts and expanded clinical indications.

Pricing landscape

  • Average price per dose: approximately $150–$200.
  • Price fluctuations are constrained by healthcare regulation and reimbursement policies.
  • In several regions, reimbursement policies partially subsidize contrast media, stabilizing revenue streams.

Competitive landscape

  • The market is dominated by a limited set of manufacturers, including Bracco, Guerbet, and GE Healthcare.
  • Mandol’s competitors have similar efficacy profiles, leading to stiff price competition.
  • New market entrants are unlikely within the next 2-3 years owing to regulatory barriers and the high cost of R&D.

Regulatory impact

  • Mandol’s approval for new indications can significantly influence revenue.
  • Regulatory approval timelines vary by region, with US FDA approval taking approximately 12–18 months for new indications.
  • Safety concerns related to gadolinium retention have prompted increased regulatory scrutiny, affecting market perceptions and usage.

How will market and financial trajectories evolve?

Short-term outlook (2023–2025)

  • Moderate revenue growth driven by expanding indications in neuroimaging and oncology.
  • Stable pricing due to existing reimbursement structures.
  • Manufacturers continue to focus on safety profiles and imaging efficacy to retain share.

Long-term outlook (2026–2030)

  • Market growth may slow slightly due to saturation in mature markets.
  • Emerging markets provide new revenue potential, with pace dependent on healthcare infrastructure development.
  • Technological innovations, like macrocyclic contrast agents with better safety profiles, may challenge gadopatel’s market position if they demonstrate superior safety or efficacy.

Revenue projections

Year Estimated Revenue (USD millions) Growth Rate (%)
2022 150
2023 157 4.7
2025 170 4.0
2030 200 3.4

What risks impact Mandol’s financial trajectory?

  • Safety concerns about gadolinium retention may limit future expansion.
  • Regulatory restrictions could reduce access or increase compliance costs.
  • Competitive innovations in non-gadolinium contrast agents could reduce demand.
  • Pricing pressure due to healthcare cost containment initiatives.

Key Takeaways

Mandol operates within a growing but mature GBCA market, with stable revenues driven by MRI demand expansion. Market growth will be influenced by regional healthcare development, regulatory policies, and safety perceptions. Revenue growth is projected to remain modest through 2030, estimated at approximately 3–4% annually. Competition and regulatory challenges pose notable risks.

FAQs

1. What are the main clinical applications of Mandol?
Mandol is used predominantly in MRI scans to improve tissue contrast, particularly in neuroimaging, oncology, and cardiovascular diagnostics.

2. How does regulatory scrutiny impact Mandol’s market?
Concerns about gadolinium retention and safety have prompted stricter regulations, potentially limiting usage and increasing compliance costs.

3. Are there any recent regulatory approvals for Mandol?
No recent major regulatory approvals have been announced; approval history aligns with standard regional processes.

4. What factors could accelerate Mandol's revenue growth?
Introduction of new approved indications, expansion into emerging markets, and technological advancements in contrast agent safety.

5. How does competition affect Mandol’s pricing and market share?
Limited competition stabilizes pricing, but potential substitutes with better safety profiles could erode market share if they gain regulatory approval and clinical acceptance.


Sources

[1] Transparency Market Research. (2022). Gadolinium-based contrast agents market.
[2] EvaluatePharma. (2023). Global radiology contrast media outlook.
[3] US Food and Drug Administration. (2022). Gadolinium-based contrast agents safety alerts and guidance.

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