Gadoquatrane - Generic Drug Details

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

Gadoquatrane is the generic ingredient in one branded drug marketed by Bayer Healthcare and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for gadoquatrane

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Applications:	15
What excipients (inactive ingredients) are in gadoquatrane?	gadoquatrane excipients list
DailyMed Link:	gadoquatrane at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for gadoquatrane

Constraining patent/regulatory exclusivity:

11,944,690

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for gadoquatrane

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

Sponsor	Phase
Bayer	Phase 3

See all gadoquatrane clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for gadoquatrane

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

US Patents and Regulatory Information for gadoquatrane

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare	AMBELVIST	gadoquatrane	SOLUTION;INTRAVENOUS	219627-006	Jun 12, 2026		RX	Yes	Yes	10,722,601			Y
Bayer Healthcare	AMBELVIST	gadoquatrane	SOLUTION;INTRAVENOUS	219627-002	Jun 12, 2026		RX	Yes	Yes	11,944,690		Y
Bayer Healthcare	AMBELVIST	gadoquatrane	SOLUTION;INTRAVENOUS	219627-005	Jun 12, 2026		RX	Yes	Yes	11,491,245			Y
Bayer Healthcare	AMBELVIST	gadoquatrane	SOLUTION;INTRAVENOUS	219627-005	Jun 12, 2026		RX	Yes	Yes	11,944,690		Y

International Patents for gadoquatrane

Country	Patent Number	Title	Estimated Expiration
Argentina	104897
Australia	2016272602
Brazil	112017026135
Canada	2987993

Gadoquatrane Market Dynamics and Financial Trajectory

Last updated: August 8, 2026

Gadoquatrane is Bayer’s investigational gadolinium-based contrast agent for magnetic resonance imaging. The product is designed to provide diagnostic enhancement at a lower gadolinium dose than conventional agents. It has no reported commercial revenue, FDA approval, Orange Book listing, or established generic launch date. Its value depends on Phase 3 performance, regulatory acceptance of reduced gadolinium exposure, hospital procurement economics, and Bayer’s ability to displace established agents such as gadobutrol, gadoterate meglumine, gadoteridol, and gadobenate dimeglumine.

What is gadoquatrane and how does it work?

Gadoquatrane, also identified as BAY 1747846, is an investigational gadolinium-based contrast agent developed by Bayer for contrast-enhanced MRI. It is a macrocyclic agent with high relaxivity, meaning it is designed to generate strong MRI signal enhancement with a lower gadolinium dose than standard products.

The commercial proposition is based on four factors:

• Reduced gadolinium administration per examination.
• Potentially lower gadolinium exposure in patients receiving repeated MRI scans.
• Diagnostic image quality comparable to established contrast agents.
• Compatibility with existing MRI workflows and intravenous administration.

Gadoquatrane is being developed for broad MRI use rather than for a single narrow indication. The principal commercial markets are expected to include central nervous system imaging, body MRI, cardiovascular imaging, and other examinations requiring contrast enhancement.

What is the FDA regulatory status of gadoquatrane?

Gadoquatrane was not FDA-approved as of the latest publicly available development information through 2024. No U.S. commercial label, NDA approval, FDA exclusivity period, or Orange Book listing had been established.

Gadoquatrane development timeline

Milestone	Status
Discovery and preclinical development	Completed
First-in-human clinical development	Completed
Phase 2 development	Completed or substantially advanced
Phase 3 development	Ongoing or reported in Bayer development disclosures
FDA approval	Not reported
European approval	Not reported
Commercial launch	Not reported
Orange Book listing	None reported
Product revenue	None reported

Bayer’s regulatory strategy depends on demonstrating that gadoquatrane is non-inferior to established contrast agents for image quality while supporting a lower-dose or lower-gadolinium-exposure profile. The likely registration package will need to address image quality, safety, renal risk, adverse reactions, dosing, and performance across relevant patient populations.

The principal regulatory risk is that reduced gadolinium dose may not create a sufficient clinical benefit to justify a new product if image quality, workflow, and safety are otherwise comparable to approved agents.

When could gadoquatrane lose exclusivity?

No definitive commercial loss-of-exclusivity date has been established because gadoquatrane has not received FDA approval. The relevant date will depend on the composition-of-matter patent, formulation patents, manufacturing patents, regulatory exclusivity, and any patent-term adjustment or extension.

For a U.S. small-molecule product, the practical exclusivity structure could include:

Protection category	Relevance to gadoquatrane
Composition-of-matter patent	Likely the principal protection if an enforceable patent covers the molecule
Formulation patent	Could protect concentration, excipients, pH, stability, or container configuration
Manufacturing patent	Could protect synthesis, purification, chelation, or impurity-control processes
Method-of-use patent	Could cover MRI use, low-dose administration, or selected patient populations
Patent-term adjustment	May extend a U.S. patent for prosecution delays
Patent-term extension	Could potentially extend one eligible patent after regulatory approval
New chemical entity exclusivity	Potentially available if FDA determines that the active ingredient qualifies
Orphan-drug exclusivity	Not expected for a broadly used MRI contrast agent unless a narrow orphan indication is approved

An exact expiration date cannot be established from the development status alone. The earliest relevant patent could expire before or after approval depending on the earliest priority date, patent family scope, prosecution history, and any terminal disclaimer.

What patents protect gadoquatrane?

Gadoquatrane’s protection is expected to rely on Bayer patent families covering the active chelate, pharmaceutical composition, preparation process, and clinical use. Public development materials identify the compound and Bayer as the developer, but they do not establish a complete, verified list of issued U.S. patent numbers and expiration dates.

Patent categories likely to affect market entry

Composition-of-matter protection

The strongest potential protection would cover the gadoquatrane molecule or a defined class of gadolinium complexes that includes it. A valid composition patent can block direct generic substitution even when a challenger avoids a particular formulation or manufacturing process.

The commercial importance of this protection will depend on:

• The patent’s earliest priority date.
• Whether the claims cover the marketed stereochemical or salt form.
• Claim breadth across related chelates.
• Written-description and enablement strength.
• Prosecution history and potential estoppel.
• Patent-term adjustment and extension.

Formulation patents

Formulation claims could cover injectable solutions containing gadoquatrane at a specified concentration, pH, buffer system, stabilizer, or impurity profile. These patents may be important if the active molecule can be manufactured independently but the marketed formulation is difficult to reproduce.

Formulation protection is usually weaker than composition protection because a generic applicant may design around the claimed excipients or concentration. Its value increases when the formulation is linked to stability, reduced free gadolinium, low osmolality, or a defined administration profile.

Method-of-use patents

Method patents could cover use in contrast-enhanced MRI, specific body regions, pediatric imaging, renal-impaired populations, or lower-dose protocols. Their enforceability depends on the approved label and the ability to show induced or direct infringement.

A method patent is less effective against generic entry when the product has substantial non-infringing uses or when physicians can prescribe the product for an unpatented use. It can still support litigation if the generic label encourages the patented use.

Manufacturing patents

Manufacturing claims may address chelation, purification, removal of free gadolinium, control of regioisomers, or production of pharmaceutical-grade material. These patents can raise technical barriers, especially if the product requires tight control of metal contamination and degradation products.

Process patents generally create less durable market protection than composition patents because a challenger can seek a non-infringing manufacturing route.

How strong is the gadoquatrane patent estate?

The patent estate cannot be rated as commercially strong or weak until the issued claims, patent-family continuity, and prosecution histories are assessed. From a market perspective, the most important distinction is whether Bayer controls a valid composition patent with sufficient remaining term at approval.

A strong estate would have:

1. A broad composition patent with a late expiration date.
2. Continuation or divisional coverage protecting narrower embodiments.
3. Formulation patents linked to the commercial injectable product.
4. Manufacturing claims that are difficult to design around.
5. Method patents covering the principal reimbursed MRI applications.
6. Regulatory exclusivity that overlaps the patent period.

A weaker estate would depend mainly on formulation and process claims, leaving the active chelate exposed to an alternative manufacturing route or a different injectable composition.

Because gadoquatrane has not entered the FDA approval process publicly, there is no approved product label against which Orange Book patent certifications can be evaluated.

What is the Orange Book status of gadoquatrane?

Gadoquatrane has no reported Orange Book listing. The Orange Book lists approved drug products and, where applicable, patents and regulatory exclusivity submitted by the NDA holder.

The absence of an Orange Book listing means:

• No approved NDA is publicly identified.
• No listed patent is available for an ANDA applicant to challenge through a Paragraph IV certification.
• No statutory 30-month stay has been triggered by an Orange Book patent dispute.
• No FDA-recognized commercial generic entry framework has been established.

If gadoquatrane is approved as a new chemical entity, FDA regulatory exclusivity could delay certain abbreviated applications even if a generic applicant has no patent dispute. The exact period would depend on the final FDA classification and approval basis.

Which companies could challenge gadoquatrane?

No company had publicly disclosed a Paragraph IV challenge to gadoquatrane because the product was not approved and had no Orange Book listing. Potential challengers would most likely include generic manufacturers with experience in sterile injectable products and MRI contrast agents.

Potential competitive groups include:

• Generic injectable manufacturers.
• Established contrast-agent suppliers.
• Specialty pharmaceutical companies with chelation or sterile-fill capabilities.
• Contract manufacturers seeking to supply a competing product.
• Companies selling lower-cost gadolinium-based contrast agents in non-U.S. markets.

The most credible challengers would need capabilities in aseptic manufacturing, metal-complex chemistry, analytical control, and global regulatory submissions. A conventional oral-generic manufacturer without sterile injectable infrastructure would face a higher technical barrier.

What generic entry risks exist for gadoquatrane?

Generic entry risk is currently low in the immediate term because gadoquatrane is not approved. The risk would rise materially after approval if:

• The composition patent has limited remaining term.
• FDA grants a short or no new-chemical-entity exclusivity period.
• The commercial product is easy to replicate.
• Bayer’s patent claims focus on narrow formulations.
• MRI providers treat products as interchangeable.
• Reimbursement policies favor the lowest acquisition cost.

The main generic pathway would likely be an ANDA if the product can be shown to have the same active ingredient, dosage form, route, strength, and pharmaceutical equivalence. Injectable contrast agents can present additional analytical and manufacturing challenges, but those challenges do not eliminate ANDA risk.

A 505(b)(2) application could also be relevant if a follow-on product differs in formulation, concentration, imaging use, or clinical positioning while relying partly on existing safety or efficacy information.

Is biosimilar risk relevant to gadoquatrane?

Biosimilar risk is not directly relevant. Gadoquatrane is a chemically synthesized small-molecule contrast agent, not a biologic. Follow-on competition would be evaluated through small-molecule generic or hybrid regulatory pathways rather than the biosimilar pathway under the Public Health Service Act.

The more relevant risks are:

• ANDA competition.
• 505(b)(2) competition.
• Authorized generic entry.
• Hospital-compounded or alternative contrast products where permitted.
• Price competition from existing approved GBCAs.

How does gadoquatrane compare with competing contrast agents?

Gadoquatrane would enter a mature market dominated by approved gadolinium-based contrast agents. Key competitors include Bayer’s gadobutrol, marketed as Gadavist in the United States; gadoterate meglumine, marketed by multiple companies; gadoteridol; gadobenate dimeglumine; and other agents used according to clinical setting and institutional preference.

Product or class	Developer or major supplier	Market position	Competitive relevance
Gadoquatrane	Bayer	Investigational	Lower-dose, high-relaxivity positioning
Gadobutrol	Bayer	Approved macrocyclic GBCA	Internal Bayer competitor and established franchise
Gadoterate meglumine	Guerbet and others	Approved macrocyclic GBCA	Strong safety and broad international use
Gadoteridol	Bracco and others	Approved macrocyclic GBCA	Established MRI agent
Gadobenate dimeglumine	Bracco and others	Approved linear GBCA	Differentiated relaxivity and organ-specific use
Generic GBCAs	Multiple suppliers	Price-driven	Procurement and reimbursement pressure

Gadoquatrane’s most important competitive challenge is internal cannibalization. If it displaces gadobutrol within Bayer’s portfolio, Bayer may gain a higher-value or more defensible product while reducing sales of an existing agent. If it fails to offer a clear clinical or economic advantage, hospitals may continue using established products.

What market dynamics will determine gadoquatrane sales?

The MRI contrast market is mature, procedure-driven, and highly sensitive to procurement economics. Product uptake will likely depend less on broad physician awareness and more on formulary decisions, radiology protocols, supply reliability, and payer treatment.

Lower gadolinium exposure

A lower-dose product could appeal to radiology departments concerned about cumulative gadolinium exposure, particularly in patients undergoing serial MRI examinations. The commercial value depends on whether regulators and clinical guidelines recognize the lower dose as a meaningful benefit.

Hospital purchasing

Large hospitals and integrated delivery networks often negotiate contrast-agent prices through tenders, group purchasing organizations, and formulary contracts. A premium product must justify its price through one or more of the following:

• Lower active-gadolinium use.
• Equivalent or improved image quality.
• Reduced waste.
• Simplified dosing.
• Better supply reliability.
• Differentiation in high-volume imaging protocols.

Generic price pressure

Established GBCAs face generic competition in several markets. A new product entering after approval would need to overcome low-cost alternatives, especially for routine MRI examinations where clinicians perceive limited differentiation.

International variation

The commercial opportunity will differ by geography. The United States has a concentrated hospital purchasing system and significant branded-product competition. Europe has strong tendering and country-specific reimbursement. Japan and other Asian markets have distinct regulatory, procurement, and clinical-use patterns.

Bayer’s global infrastructure could support broad launch execution, but international pricing pressure may limit net sales even if unit volume grows.

What is the financial trajectory for gadoquatrane?

Gadoquatrane has no reported product revenue because it has not been approved or commercialized. Bayer does not publicly report a standalone valuation, sales forecast, development cost, or asset-level operating margin for gadoquatrane in its regular financial reporting.

The financial trajectory is therefore milestone-driven:

Stage	Financial profile
Clinical development	Cash outflow for trials, manufacturing, regulatory work, and intellectual property
Regulatory submission	Higher filing, validation, and commercial-readiness costs
Initial launch	Sales ramp constrained by formulary review and hospital contracts
Early commercialization	Potential price premium if lower-dose benefit is accepted
Mature commercialization	Volume and margin shaped by GBCA competition and generic entry
Post-exclusivity	Likely price erosion and possible share retention through brand loyalty or contracting

Bayer’s upside would come from premium pricing, adoption in repeated-use MRI populations, and replacement of competing products. The downside would come from failed or delayed Phase 3 development, safety findings, lack of measurable clinical differentiation, and cannibalization of Bayer’s own gadobutrol franchise.

What licensing deals affect gadoquatrane?

No major public licensing transaction specifically transferring or co-developing gadoquatrane had been reported in the available development disclosures. Bayer appears to control the primary development program.

The absence of a disclosed licensing deal reduces visibility into external validation and milestone obligations. It also suggests that Bayer has retained strategic control over development, regulatory filing, manufacturing, and commercialization decisions.

What patent litigation affects gadoquatrane?

No reported Paragraph IV litigation, patent-infringement case, settlement agreement, or generic challenge affected gadoquatrane as of the latest available public development information. That status follows from the product’s pre-approval position and lack of an Orange Book listing.

Future litigation could arise from:

• ANDA Paragraph IV certifications.
• Patent ownership or inventorship disputes.
• Process patent claims.
• Trade-secret allegations involving chelation or purification.
• Contract-manufacturing disputes.
• Patent opposition or revocation proceedings outside the United States.

What launch scenarios are possible for gadoquatrane?

Premium differentiated launch

Under the strongest scenario, gadoquatrane demonstrates equivalent or superior image quality at materially lower gadolinium exposure. Bayer secures regulatory approval, obtains favorable formulary placement, and uses the product to capture premium pricing in high-volume and repeat-MRI segments.

Broad but price-constrained launch

Gadoquatrane receives approval but competes mainly on operational or safety positioning. Hospitals adopt it selectively, while tendering limits price. Revenue grows steadily but remains below a major blockbuster threshold.

Narrow specialist launch

The product is approved for a limited set of imaging applications or patient groups. Commercial uptake depends on guideline inclusion and specialist preference. Sales remain modest and may not fully offset development and launch costs.

Delayed or unsuccessful launch

A trial fails to establish non-inferiority, safety concerns emerge, or the lower-dose benefit lacks regulatory and payer value. Bayer delays filing, narrows the program, or terminates development.

Key Takeaways

• Gadoquatrane is an investigational Bayer MRI contrast agent identified as BAY 1747846.
• The product is designed to deliver contrast enhancement with lower gadolinium exposure.
• No FDA approval, Orange Book listing, commercial revenue, or Paragraph IV litigation was reported through the latest available development information.
• The core commercial risk is failure to establish a meaningful advantage over established GBCAs.
• Generic risk is currently deferred but could become significant after approval, particularly if composition protection is limited.
• Biosimilar competition does not apply because gadoquatrane is a synthetic small molecule.
• Bayer’s principal strategic risk is cannibalization of gadobutrol sales.
• Hospital procurement, reimbursement, tender pricing, and image-quality evidence will determine launch economics.
• A reliable patent-expiration date cannot be assigned without a verified issued-patent and regulatory-exclusivity record.

FAQs

Is gadoquatrane approved by the FDA?

No FDA approval for gadoquatrane had been reported through the latest available public development information.

Who manufactures gadoquatrane?

Bayer is the identified developer and prospective manufacturer or commercial sponsor of gadoquatrane.

Does gadoquatrane have an Orange Book patent?

No Orange Book listing had been reported because gadoquatrane had not received FDA approval.

Will gadoquatrane compete with Gadavist?

Yes. Gadavist is Bayer’s established gadobutrol product, making internal portfolio positioning a central commercial issue for gadoquatrane.

Is gadoquatrane a gadolinium-free MRI contrast agent?

No. Gadoquatrane is a gadolinium-based contrast agent designed to reduce the administered gadolinium dose, not eliminate gadolinium.

References

1. Bayer AG. (2024). Annual report 2023. Bayer AG.

2. Bayer AG. (2024). Pharmaceuticals pipeline and development portfolio. Bayer AG.

3. ClinicalTrials.gov. (2024). Studies of gadoquatrane in magnetic resonance imaging. U.S. National Library of Medicine.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

5. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

6. U.S. Food and Drug Administration. (2024). Drug competition action plan and generic drug development resources. U.S. Department of Health and Human Services.