Last Updated: June 26, 2026

MAGNEVIST Drug Patent Profile


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When do Magnevist patents expire, and what generic alternatives are available?

Magnevist is a drug marketed by Bayer Hlthcare and is included in two NDAs.

The generic ingredient in MAGNEVIST is gadopentetate dimeglumine. There is one drug master file entry for this compound. Additional details are available on the gadopentetate dimeglumine profile page.

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Summary for MAGNEVIST
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 21
Clinical Trials: 30
Patent Applications: 2,558
Drug Prices: Drug price information for MAGNEVIST
What excipients (inactive ingredients) are in MAGNEVIST?MAGNEVIST excipients list
DailyMed Link:MAGNEVIST at DailyMed
Recent Clinical Trials for MAGNEVIST

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

SponsorPhase
Dipan ShahN/A
GuerbetN/A
Astellas Pharma IncPhase 4

See all MAGNEVIST clinical trials

US Patents and Regulatory Information for MAGNEVIST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 019596-001 Jun 2, 1988 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 021037-001 Mar 10, 2000 DISCN Yes 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

Expired US Patents for MAGNEVIST

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 019596-001 Jun 2, 1988 ⤷  Start Trial ⤷  Start Trial
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 021037-001 Mar 10, 2000 ⤷  Start Trial ⤷  Start Trial
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 019596-001 Jun 2, 1988 ⤷  Start Trial ⤷  Start Trial
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 019596-001 Jun 2, 1988 ⤷  Start Trial ⤷  Start Trial
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 021037-001 Mar 10, 2000 ⤷  Start Trial ⤷  Start Trial
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 021037-001 Mar 10, 2000 ⤷  Start Trial ⤷  Start Trial
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 019596-001 Jun 2, 1988 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for MAGNEVIST (Gadopentetate Dimeglumine)

Last updated: April 26, 2026

MAGNEVIST (gadopentetate dimeglumine) is a prescription gadolinium-based contrast agent (GBCA) whose commercial trajectory is shaped by (1) MRI volume growth and radiology throughput, (2) payer and formulary decisions driven by MRI cost controls and GBCA price competition, (3) safety-driven GBCA class shifts after chelation and retention concerns, and (4) the maturation of generic and biosimilar-adjacent GBCA availability in select markets. The result is a market that still expands in absolute MRI demand but compresses in unit economics and share for older, lower-advantage molecules.

What is MAGNEVIST’s market role within GBCAs?

MAGNEVIST is a linear, non-ionic GBCA used for contrast-enhanced MRI. In practice, its uptake depends on:

  • Radiology protocol selection: hospitals and imaging centers standardize on one or two GBCA SKUs to simplify stocking and staff workflow.
  • Procurement: distributors negotiate price and contract terms with health systems, which tends to favor either the lowest-cost option within the formulary or the molecule with the best clinical differentiation under local policy.
  • Formulary policy: safety and retention risk management has shifted preference toward macrocyclic GBCAs in multiple geographies, while linear agents remain used where policy allows.

Implication for market dynamics: MAGNEVIST competes not only on price but also on hospital-level risk governance and internal standard-of-care protocols.

How do policy and safety perceptions affect demand?

GBCA use is universal in MRI contrast, but choice of agent is increasingly policy-led. After safety concerns related to gadolinium retention and conditional restrictions, payers and providers in many markets moved toward macrocyclic agents when clinically appropriate. That shift typically does not eliminate use of linear GBCAs; it changes share.

MAGNEVIST’s commercial headwinds track three dynamics:

  1. Protocol substitution: clinicians switch to preferred agents when imaging quality is comparable and retention risk differences align with policy.
  2. Contracting bias: health systems favor suppliers with strong formulary placement for the preferred GBCA class.
  3. Utilization controls: some institutions require internal justification for alternatives if a preferred GBCA is available.

Net effect: MAGNEVIST can keep baseline demand as MRI volumes rise, but its incremental growth tends to be weaker than preferred GBCA classes, and its pricing power is structurally constrained.

What market forces drive unit price and revenue trajectory?

MAGNEVIST revenue trends for a mature GBCA are typically dominated by:

  • Generic entry and competitive pricing: once volume is established, pricing becomes the main lever.
  • Tender cycles: annual or semiannual hospital tenders re-rank vendors by contract price.
  • Mix shift within MRI: even as MRI volumes rise, growth can concentrate in higher-utilization or higher-reimbursement segments that may favor different agents depending on policy and negotiated bundles.

Pricing pressure map (typical for mature GBCA products)

Driver Direction of impact on MAGNEVIST unit economics Mechanism
GBCA class preference Down Policy tends to steer toward macrocyclic agents where permitted
Formulary standardization Down Standard agents win recurring use
Tender-based procurement Down Low-cost contracts displace non-winning SKUs
MRI volume growth Up More contrast-enhanced scans lift baseline demand
Local competition Down Multi-vendor supply reduces price leverage

Implication: revenue can remain stable-to-declining in many markets even while total GBCA demand grows, because the product’s share and price per dose compress.

How does the product’s competitive landscape shape share outcomes?

MAGNEVIST competes with a portfolio of GBCAs across:

  • Macrocyclic GBCAs (often preferred in risk-managed policies)
  • Other linear agents that may win on price and availability
  • Formulary-specific winners at major health system accounts

Share is determined by:

  • Contract retention: once a health system standardizes, switching costs delay migration away from the chosen SKU.
  • Clinical committee decisions: neurology, radiology leadership, and pharmacy committees set local preferred agents.
  • Stocking and substitution: pharmacies often stock preferred agents first and can substitute with minimal friction if permitted.

What financial trajectory should investors expect from MAGNEVIST?

MAGNEVIST’s “financial shape” typically follows a pattern seen across mature GBCA franchises:

  • Mid-cycle decline in average selling price (ASP) as tenders and competition progress.
  • Slower decline or flat-to-low growth in volume depending on MRI demand and local protocol inertia.
  • Revenue elasticity that is weaker than MRI volume growth due to substitution risk.

In investment terms, MAGNEVIST behaves like a mature hospital product:

  • revenue depends on large-account renewals,
  • margins are exposed to pricing renegotiations,
  • growth is capped by GBCA class policy shifts and substitution.

Where do geography and regulatory status matter most?

Commercial outcomes vary by:

  • Local risk guidance for linear vs macrocyclic GBCAs,
  • National or regional tender structures,
  • Availability and pricing of competing molecules.

Even within the same global molecule, MAGNEVIST’s market position can differ substantially by region due to differing governance.

What hard data points tie MAGNEVIST to safety-driven use changes?

MAGNEVIST carries safety-relevant labeling consistent with GBCA retention risk governance. U.S. FDA communications and GBCA labeling have emphasized steps to reduce risk from gadolinium retention, particularly for populations with higher retention risk. Labeling also guides use at the lowest dose necessary for adequate imaging and includes warnings about patient population considerations. (See U.S. prescribing information and FDA safety communications.) [1,2]

These safety governance measures are a key variable in why GBCA choice shifts at the provider level, which in turn affects product revenue.

What market metrics track MAGNEVIST performance in practice?

Organizations monitoring GBCA franchises typically track:

  • Tender win rate at major hospital systems
  • Preferred formulary listing status
  • Dose utilization per MRI volume (contrast utilization)
  • ASP and net price over tender cycles
  • Share by GBCA class (linear vs macrocyclic mix)

For MAGNEVIST, the critical metric is not just total MRI contrast scans but share of contrast-enhanced MRI using its molecule within the allowed formulary set.

How should R&D and business teams interpret MAGNEVIST’s trajectory?

MAGNEVIST’s trajectory implies the economics of:

  • Incremental life-cycle growth is constrained once formulary substitution starts.
  • Value depends on maintaining institutional footprint through contract renewals and reliable supply.
  • Competitive advantage is mostly procurement- and protocol-driven rather than differentiation-led.

For pipeline strategy, it points to:

  • targeting GBCA candidates that align with the preferred safety profile governing agent selection, and
  • designing for formulary acceptance (policy alignment, dosing simplicity, and comparable image quality).

Market outlook: what is the directionality?

Directional conclusion based on the known GBCA policy and competitive structure:

  • MRI volumes should continue to support baseline demand for GBCAs.
  • MAGNEVIST’s unit economics likely remain pressured by ongoing GBCA competition and tender price compression.
  • Its revenue trajectory should track substitution away from linear agents where policy preference is stronger, producing modest growth potential and higher probability of share erosion absent localized contract resilience.

Key Takeaways

  • MAGNEVIST’s demand is supported by MRI contrast use, but its growth is capped by formulary substitution and GBCA class preference.
  • Tender-driven contracting and price competition are the dominant drivers of its ASP and revenue trajectory.
  • Safety governance around gadolinium retention has shifted agent choice toward preferred profiles in multiple markets, creating structural headwinds for linear GBCA share.
  • The most actionable operating metric for MAGNEVIST is preferred formulary status and tender win rate at major health systems, not aggregate MRI volume alone.

FAQs

  1. What type of drug is MAGNEVIST?
    MAGNEVIST is a prescription gadolinium-based MRI contrast agent containing gadopentetate dimeglumine.

  2. Why does MAGNEVIST face pricing pressure?
    GBCA markets are procurement-driven with tender cycles and competitive supply, which compresses ASP over time.

  3. Does MAGNEVIST still get used despite safety concerns around gadolinium retention?
    Yes. Safety governance focuses on appropriate use and risk mitigation; it changes agent selection patterns rather than eliminating GBCA use.

  4. What has the biggest impact on MAGNEVIST market share?
    Local formulary decisions and protocol standardization at hospital systems, driven by policy and contracting.

  5. What should companies monitor to forecast MAGNEVIST revenue?
    Contract renewals, formulary listing, ASP changes through tenders, and mix shifts in GBCA class usage (linear vs macrocyclic).


References

[1] U.S. Food and Drug Administration. (n.d.). Drug Safety Communications and related information on gadolinium-based contrast agents. FDA. https://www.fda.gov/ (search FDA site for “gadolinium retention safety communication”)
[2] U.S. Food and Drug Administration. (n.d.). Magnevist (gadopentetate dimeglumine) prescribing information. FDA label repository. https://www.accessdata.fda.gov/scripts/cder/daf/

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