MANGAFODIPIR TRISODIUM - Generic Drug Details

What are the generic drug sources for mangafodipir trisodium and what is the scope of freedom to operate?

Mangafodipir trisodium is the generic ingredient in one branded drug marketed by Ic Targets and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for MANGAFODIPIR TRISODIUM

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	2
DailyMed Link:	MANGAFODIPIR TRISODIUM at DailyMed

Recent Clinical Trials for MANGAFODIPIR TRISODIUM

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

Sponsor	Phase
IC TARGETS AS	PHASE2
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1

See all MANGAFODIPIR TRISODIUM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for MANGAFODIPIR TRISODIUM

V08CA	Paramagnetic contrast media
V08C	MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for MANGAFODIPIR TRISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997		DISCN	No	No

Expired US Patents for MANGAFODIPIR TRISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997	4,647,447
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997	5,091,169
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997	4,992,554
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997	5,223,243
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997	4,933,456

Mangafodipir Trisodium Market Dynamics, Patent Position, and Financial Trajectory

Last updated: September 4, 2026

Mangafodipir trisodium is a manganese-based magnetic resonance imaging contrast agent formerly marketed as Teslascan. Its commercial trajectory was shaped by a narrow diagnostic indication, competition from hepatobiliary gadolinium agents, limited global adoption, and eventual withdrawal from major markets. Public filings do not report standalone Teslascan revenue, but available regulatory and company disclosures indicate a mature, discontinued product with no material current commercial franchise.

What is mangafodipir trisodium used for?

Mangafodipir trisodium was developed for contrast-enhanced MRI of the liver. The product was designed to improve detection and characterization of focal liver lesions, including metastases and other abnormalities, through manganese-based signal enhancement.

Teslascan was administered intravenously at a dose of approximately 10 micromol/kg. Mangafodipir is taken up by hepatocytes and produces delayed liver enhancement, creating a diagnostic distinction between normal liver tissue and lesions with different cellular or vascular characteristics.[1]

The product was commercialized primarily by Nycomed and later by Amersham and GE Healthcare following corporate acquisitions. Its commercial identity was Teslascan, with regional regulatory and distribution differences.

Mangafodipir trisodium product profile

Attribute	Detail
Active ingredient	Mangafodipir trisodium
Product name	Teslascan
Therapeutic category	MRI contrast medium
Imaging target	Liver and focal hepatic lesions
Contrast mechanism	Manganese-based hepatobiliary enhancement
Route	Intravenous
Typical dose	Approximately 10 micromol/kg
Original commercial sponsor	Nycomed
Later commercial owner	Amersham, then GE Healthcare
Current status	Commercially discontinued or no longer broadly marketed
Primary competitive class	Hepatobiliary gadolinium-based contrast agents

When did mangafodipir trisodium lose exclusivity?

Mangafodipir trisodium lost meaningful commercial exclusivity before the product was withdrawn from broad use. Its original compound and formulation patents were filed decades ago, making any ordinary patent protection expired by the late 2000s or early 2010s, depending on jurisdiction and patent family.

The commercial barrier was therefore regulatory approval, manufacturing capability, clinical familiarity, and market access rather than an active blocking patent estate.

Patent and exclusivity timeline

Period	Event	Commercial significance
Late 1980s to early 1990s	Core manganese-chelate patents filed	Established the original composition and use position
1990s	Teslascan regulatory approvals in selected markets	Created the primary commercial window
Late 1990s to early 2000s	Expansion under Nycomed, Amersham and GE Healthcare ownership	Increased distribution reach
Late 2000s	Core patent protection reached the end of ordinary life	Generic or alternative development became legally more feasible
2010s	Product availability declined and marketing authorizations were withdrawn or allowed to lapse in some jurisdictions	Reduced global commercial relevance
Current period	No major active marketed Teslascan franchise identified	Revenue opportunity is limited without redevelopment

The United States patent term for older pharmaceutical patents depended on filing and issue dates, with pre-1995 patents generally subject to the earlier of 17 years from grant or 20 years from the earliest effective nonprovisional filing date. Patent-term adjustment, terminal disclaimers and patent-family differences can alter the precise expiration date.[2]

What patents protect mangafodipir trisodium?

The original IP position centered on manganese complexes of dipyridoxyl derivatives, pharmaceutical compositions, and diagnostic uses. The relevant patent scope was broader than a single finished product and likely covered:

• Manganese chelates based on dipyridoxyl-related ligands.
• Paramagnetic contrast compositions.
• Use in MRI and other diagnostic imaging.
• Formulations suitable for intravenous administration.
• Manufacturing and purification processes.

The strongest historical protection was the composition-of-matter position. Formulation and method-of-use patents would have provided secondary protection, but their commercial value declined as the core compound patents expired and competing contrast agents gained adoption.

Patent-strength assessment

Patent category	Historical strength	Current commercial value
Core manganese-chelate composition	High	Low to negligible after expiration
MRI diagnostic use	Moderate to high	Low after expiration
Injectable formulation	Moderate	Low unless a new formulation is developed
Manufacturing process	Variable	Potentially relevant for quality and cost
New therapeutic or imaging use	Potentially high if novel	Could support redevelopment

Publicly available sources do not indicate a current, commercially blocking patent estate that would prevent development of a new mangafodipir trisodium product. A developer could still face freedom-to-operate issues involving manufacturing routes, specific formulations, combination imaging protocols, or later-filed patents covering new uses.

What is the Orange Book status of mangafodipir trisodium?

Mangafodipir trisodium does not have a significant current Orange Book commercial position. Teslascan was associated with a U.S. prescription drug application, but the product is not an active, high-volume U.S. reference product supporting a current generic market.

The FDA Orange Book identifies approved drug products and certain patent and exclusivity information. An inactive or withdrawn product listing does not create a current market opportunity by itself. A company seeking to reintroduce mangafodipir trisodium would likely need to assess whether the appropriate pathway is:

1. Reliance on an existing approved reference product, if legally and regulatorily available.
2. A new drug application supported by contemporary chemistry, manufacturing and controls data.
3. A 505(b)(2) application using published literature or prior findings, subject to FDA requirements.
4. A full development program if the proposed indication, formulation or use materially differs from the historical product.[3]

No meaningful current Paragraph IV dispute involving Teslascan is evident in the public record. That is consistent with an inactive product rather than an active, contested generic market.

What was the FDA regulatory status of Teslascan?

Teslascan received regulatory approval in selected markets for liver MRI, but its market history was uneven. The product did not become a durable global standard for liver imaging.

The FDA has historically listed Teslascan as a prescription MRI contrast product. Its commercial availability later declined, and the product was discontinued in the United States for business reasons rather than because of a widely documented safety withdrawal. FDA records distinguish between a product being discontinued for commercial reasons and a product withdrawn from sale for safety or efficacy concerns.[3]

European regulatory records similarly show a product with declining commercial relevance and eventual withdrawal or loss of active authorization in the relevant market. The exact date and legal mechanism differed by jurisdiction and authorization status.[1]

Regulatory factors affecting the product

Mangafodipir faced several regulatory and clinical disadvantages:

• Contrast-agent safety standards became more demanding.
• Gadolinium-based agents had larger clinical evidence bases.
• Radiology departments standardized around established products.
• Hospitals preferred products with broad indications and reliable supply.
• The product’s diagnostic role was narrower than that of multipurpose extracellular agents.
• Concerns surrounding contrast-agent risk, including metal retention and patient selection, increased scrutiny across the category.

How does mangafodipir compare with competing liver MRI contrast agents?

Mangafodipir competed mainly with gadolinium-based contrast media, particularly agents with hepatobiliary uptake.

Product or class	Active agent	Liver specificity	Commercial position
Teslascan	Mangafodipir trisodium	Hepatobiliary manganese-based	Discontinued or severely limited
Eovist/Primovist	Gadoxetate disodium	Hepatobiliary	Strong specialist position
MultiHance	Gadobenate dimeglumine	Partial hepatobiliary uptake	Established but less liver-specific
Gadobutrol, gadoterate and related agents	Various gadolinium chelates	Primarily extracellular	Broad MRI use
Noncontrast MRI protocols	No contrast agent	Variable	Growing role in selected indications

Gadoxetate disodium became the principal commercial benchmark for hepatobiliary liver MRI. Its value proposition included dedicated liver imaging, broad clinical familiarity, and integration into established MRI workflows. The presence of an approved, commercially supported hepatobiliary gadolinium agent reduced the incentive to revive a manganese-based product.

What drove the financial trajectory of mangafodipir trisodium?

Mangafodipir’s financial trajectory followed a product-life-cycle pattern:

1. Development and launch: The product occupied a differentiated niche in liver MRI.
2. Specialist adoption: Sales depended on radiology centers performing contrast-enhanced hepatic imaging.
3. Competitive compression: Gadolinium-based agents expanded their clinical and commercial position.
4. Portfolio rationalization: Ownership changes moved the product into larger imaging portfolios where its revenue contribution was relatively small.
5. Discontinuation: Declining commercial attractiveness outweighed the value of continued manufacturing and regulatory maintenance.

Public company filings from GE Healthcare and predecessor companies generally reported broader imaging or pharmaceutical segments rather than Teslascan revenue as a separate line item. No reliable public dataset establishes annual Teslascan sales, gross margin, or product-level profitability.

Financial trajectory

Commercial phase	Revenue profile	Main economic driver
Initial launch	Low to moderate	Premium pricing and differentiated liver imaging
Early adoption	Moderate in selected markets	Specialist radiology uptake
Competitive maturity	Declining	Substitution by gadoxetate and other agents
Late commercial period	Low	Limited demand and portfolio prioritization
Post-discontinuation	Minimal or zero reported product revenue	No broad marketed franchise

The most important economic issue was not loss of patent exclusivity alone. It was the combination of a limited indication, low switching costs for imaging centers, competition from established gadolinium products, and the cost of maintaining sterile injectable manufacturing.

What manufacturing and IP barriers affect a new mangafodipir product?

A new entrant would face moderate technical barriers even if the original patents have expired.

Manufacturing barriers

Mangafodipir products require:

• Controlled synthesis of the ligand and manganese complex.
• Tight control of metal-to-ligand stoichiometry.
• Limits on free manganese and related impurities.
• Sterile injectable production.
• Stability testing for the finished solution.
• Validated analytical methods for complex identity and degradation.
• Consistent supply of pharmaceutical-grade starting materials.

Manganese chemistry creates quality-control requirements that differ from conventional gadolinium chelates. A sponsor would need to establish the chemical form, dissociation profile, impurity limits and long-term stability under current regulatory standards.

Intellectual-property barriers

The historical core patents are unlikely to be the primary obstacle. More relevant issues include:

• Later manufacturing patents.
• New dosage or concentration claims.
• Improved stability formulations.
• Combination use with specific MRI sequences.
• New liver, pancreatic or oncology imaging indications.
• Device or administration claims.
• Proprietary analytical methods.

A reformulated product could generate new patent protection, but the claims would need to provide a clinically meaningful distinction from the historical Teslascan product.

Which companies are challenging or replacing mangafodipir trisodium?

No major company is publicly identified as pursuing a conventional generic challenge to Teslascan at scale. The competitive threat came from substitution rather than Paragraph IV litigation.

Key competitive groups included:

• GE Healthcare, as historical owner and distributor of Teslascan.
• Bayer, associated with gadoxetate disodium under the Eovist and Primovist brands.
• Bracco, with gadobenate dimeglumine and other contrast products.
• Guerbet, with broad gadolinium-based contrast offerings.
• Generic contrast-media manufacturers, which increased price competition in established MRI categories.

The current market is therefore a replacement market. A revived mangafodipir product would compete against entrenched hepatobiliary and extracellular agents, not against an active Teslascan generic launch wave.

What generic entry risks exist for mangafodipir trisodium?

Generic entry risk is low in the conventional sense because the branded product is no longer a major active market. The more material risk is substitution by existing MRI contrast agents.

A new mangafodipir product would face:

• Weak prescriber continuity after years of limited availability.
• Lack of current commercial infrastructure.
• Potential need for updated clinical evidence.
• Hospital formulary resistance.
• Price pressure from generic gadolinium agents.
• Procurement preference for suppliers with broad contrast portfolios.
• Regulatory scrutiny over manganese exposure and product quality.

Generic development could be technically feasible if a reference product and regulatory pathway were available, but the addressable market would likely be too small to support a large-scale generic investment without a differentiated indication.

What licensing deals affected mangafodipir trisodium?

The major commercial ownership changes were corporate transactions rather than publicly prominent standalone licensing deals. Nycomed’s imaging business was acquired by Amersham, and Amersham was later acquired by GE Medical Systems, creating GE Healthcare.[4][5]

These transactions transferred commercial rights, manufacturing capabilities and regulatory assets. Public disclosures did not establish a major royalty-bearing licensing structure that continued to generate material revenue after the product’s commercial decline.

What patent litigation affects mangafodipir trisodium?

No major current patent litigation involving mangafodipir trisodium is evident in the public record. The absence of active litigation reflects the product’s discontinued commercial status and the expiration of its principal historical patent protection.

The litigation risk for a redevelopment program would instead involve:

• Freedom to operate around manufacturing methods.
• Patentability of new formulations.
• Use patents for oncology or hepatobiliary imaging.
• Regulatory exclusivity associated with a new indication.
• Trade-secret protection for analytical and manufacturing processes.

What is the commercial outlook for mangafodipir trisodium?

The standalone commercial outlook is weak. The product has no meaningful current revenue base, limited market visibility, and strong competition from established hepatobiliary gadolinium agents.

A viable redevelopment thesis would require a new value proposition, such as:

• Improved lesion characterization.
• Lower risk in a defined patient population.
• A clinically useful manganese-based imaging advantage.
• A new oncology indication.
• Better renal or hepatobiliary safety positioning.
• A formulation compatible with modern MRI workflows.

Without a new clinical or safety advantage, the product would likely remain commercially unattractive despite low patent barriers. The main opportunity is not a simple generic launch. It is a differentiated diagnostic relaunch supported by new clinical evidence and a defensible regulatory or patent position.

Key Takeaways

• Mangafodipir trisodium was marketed as Teslascan for liver MRI.
• The product’s original composition and use patents are historical rather than current commercial barriers.
• Public filings do not disclose standalone Teslascan revenue.
• The product’s decline resulted from market substitution, limited indication breadth, manufacturing economics and portfolio rationalization.
• Gadoxetate disodium and other gadolinium-based agents replaced mangafodipir in most commercial liver MRI workflows.
• No material current Paragraph IV campaign or patent litigation appears to affect the product.
• A new entrant would need differentiation beyond the expired historical product.
• The commercial opportunity is redevelopment-driven, not a conventional generic opportunity.

FAQs About Mangafodipir Trisodium

Is mangafodipir trisodium still available for MRI?

Teslascan is no longer broadly available as a mainstream commercial MRI contrast product. Availability may vary by jurisdiction, but it does not have the global market presence of current gadolinium-based contrast agents.

Was Teslascan withdrawn because it was unsafe?

Available regulatory records distinguish commercial discontinuation from withdrawal for safety or efficacy reasons. The product’s decline is principally associated with commercial and competitive factors, although evolving contrast-agent safety standards affected the category.

Can a company develop a generic version of Teslascan?

Potentially, but the commercial case is limited. A sponsor would need to address regulatory pathway, reference-product availability, sterile manufacturing, manganese-related quality controls and a small market opportunity.

What drug replaced mangafodipir trisodium?

Gadoxetate disodium, marketed as Eovist in the United States and Primovist in several other markets, became a leading hepatobiliary MRI alternative. Other gadolinium-based agents also captured imaging volume.

Does mangafodipir trisodium have biosimilar risk?

No. Mangafodipir trisodium is a chemically synthesized small-molecule contrast agent, not a biologic. The relevant competitive risks are generic substitution, therapeutic substitution and development of newer contrast media.

References

1. European Medicines Agency. (n.d.). Teslascan: EPAR and product information. European Union.

2. United States Patent and Trademark Office. (n.d.). Patent term adjustment and patent term calculation guidance. U.S. Department of Commerce.

3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA and Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Department of Health and Human Services.

4. GE Healthcare. (2001). Annual report. General Electric Company.

5. General Electric Company. (2004). Annual report. General Electric Company.