GADAVIST Drug Patent Profile

When do Gadavist patents expire, and when can generic versions of Gadavist launch?

Gadavist is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in GADAVIST is gadobutrol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the gadobutrol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gadavist

A generic version of GADAVIST was approved as gadobutrol by HENGRUI PHARMA on November 17^th, 2022.

Summary for GADAVIST

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	29
Patent Applications:	445
Drug Prices:	Drug price information for GADAVIST
What excipients (inactive ingredients) are in GADAVIST?	GADAVIST excipients list
DailyMed Link:	GADAVIST at DailyMed

See drug prices for GADAVIST

Recent Clinical Trials for GADAVIST

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

Sponsor	Phase
Brigham and Women's Hospital	NA
Lipella Pharmaceuticals, Inc.	Early Phase 1
Christopher J Chermansky, MD	Early Phase 1

See all GADAVIST clinical trials

Pharmacology for GADAVIST

Drug Class	Gadolinium-based Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

US Patents and Regulatory Information for GADAVIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-006	Dec 18, 2013	AP	RX	Yes	Yes
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-003	Mar 14, 2011	AP	RX	Yes	Yes
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-001	Mar 14, 2011	AP	RX	Yes	Yes
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-002	Mar 14, 2011	AP	RX	Yes	Yes
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011	AP	RX	Yes	Yes
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-004	Mar 14, 2011	AP	RX	Yes	Yes

Expired US Patents for GADAVIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-002	Mar 14, 2011	5,980,864
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-006	Dec 18, 2013	5,980,864
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011	5,980,864
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-003	Mar 14, 2011	5,980,864
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-004	Mar 14, 2011	5,980,864
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-001	Mar 14, 2011	5,980,864

International Patents for GADAVIST

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

Country	Patent Number	Title	Estimated Expiration
Spain	2074219
Japan	2968367
Japan	H05320146	PREPARATION OF 1,4,7,10-TETRAAZACYCLO- DODECANE-BUTYLTRIOL, ITS GADOLINIUM COMPLEX, PHARMACEUTICAL PRODUCT AND DIAGNOSTIC AGENT CONTAINING THIS AND ITS COMPOUND AND PREPARATION OF PHARMACEUTICAL PRODUCT
Ireland	910902
Hong Kong	1002811
Hungary	T60478
New Zealand	237461	10-TRIHYDROXYBUTYL-1,4,

Supplementary Protection Certificates for GADAVIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0448191	CA 2001 00009	Denmark

GADAVIST (Gadobutrol) Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

GADAVIST (gadobutrol) is a macrocyclic gadolinium-based contrast agent (GBCA) used for MRI. Its market trajectory in the US has been shaped by (1) competitive pressure across the US GBCA class, (2) labeling-driven adoption of macrocyclic GBCAs, and (3) life-cycle dynamics tied to patent/market exclusivity in key geographies. Commercial growth has also depended on hospital purchasing behavior, tenders, and formulary preferences tied to safety perceptions and supply continuity rather than differentiated clinical superiority.

What is the commercial market structure for GADAVIST?

GBCA market overview

The GBCA market is concentrated around a small set of branded products and is defined by:

• Hospital procurement systems (group purchasing organizations, direct tenders, and contract pharmacy pathways)
• Switching friction (brand lock-in in radiology departments)
• Safety- and compliance-driven selection (macrocyclic preference in many institutions)
• Regulatory and stewardship constraints tied to gadolinium deposition and labeling

Competitive set (US)

GADAVIST competes primarily with other GBCA brands, including:

• DOTAREM (gadoterate meglumine; macrocyclic)
• PROHANCE (gadoteridol; macrocyclic)
• OMNISCAN (gadoversetamide; linear, largely displaced in many formularies)
• OPTIMARK (gadoversetamide; another linear option)
• Multi-generic market segments where applicable

Even where multiple products show similar imaging performance, procurement decisions often come down to contract price, availability, and internal policy around macrocyclic agents.

How does policy and labeling influence demand?

Macrocyclic selection

Macrocyclic GBCAs (including gadobutrol) are widely preferred in formularies relative to linear agents, because policy and stewardship frameworks reduced linear use after gadolinium retention concerns. This has supported demand for macrocyclic options as radiology departments standardize around the class with the lowest perceived retention risk.

Renal safety governance

Hospital demand is influenced by institutional protocols for:

• Patients with severe renal impairment
• Pregnancy/lactation pathways
• Dosing guidance and documentation requirements for GBCA exposure

Macrocyclic agents like gadobutrol benefit from a “default safest-in-class” purchasing pattern in facilities with conservative gadolinium governance.

What are the key market dynamics shaping GADAVIST’s pricing and share?

1) Tender-driven pricing

GBCA sales behave like other hospital injectables:

• Annual contract renewals and tender outcomes reset net pricing
• Price competition can be intense when multiple macrocyclic GBCA options are on formulary
• Switching can be slow, but when contracts change, market share can move quickly

2) Formulary stickiness plus change events

GADAVIST tends to face two opposite forces:

• Stickiness: Radiology workflows, ordering systems, and historical inventory reduce switching between macrocyclic brands
• Change events: New purchasing contracts, supply disruptions, or internal safety audits can trigger substitution

3) Supply and continuity

For injectable contrast agents, supply reliability is a commercial driver:

• Facilities avoid products with perceived stock-out risk
• Manufacturers that maintain consistent distribution often retain preferred status even if price is slightly higher

4) Oncology and advanced MRI mix

Gadobutrol demand is correlated with:

• Growth in MRI volume
• Shift toward advanced MRI protocols where contrast enhancement is routine
• Broader adoption of MRI in oncology and neurologic indications

What drives GADAVIST’s financial trajectory?

1) Revenue dependence on MRI procedure volume

GBCA revenue is closely coupled to:

• Patient throughput and imaging utilization trends
• Technology and reimbursement dynamics that affect MRI demand
• Site-of-care mix (hospital outpatient vs office-based MRI)

2) Brand economics in a competitive macrocyclic set

GADAVIST is not priced in a vacuum. Net revenue is typically determined by:

• Contract pricing versus DOTAREM and PROHANCE
• Relative formulary position and utilization allocation
• Volume-based rebate structures and channel mix

3) Life-cycle timing

Financial performance typically follows a pattern:

• Pre-expiry growth and share capture when no generic pressure exists for the relevant segment
• Post-expiry or exclusivity end, where pricing pressure can rise and volume can redistribute

For GADAVIST, life-cycle effects are strongest in jurisdictions where exclusivity or patent barriers weaken, increasing generic or alternative-brand penetration.

How does financial performance compare to major GBCA peers?

Benchmark structure (what to expect in the financials)

For GBCAs in general, revenue trajectories tend to show:

• Moderate growth in imaging volumes, offset by pricing compression during contract renewals
• Share shifts during tender cycles among macrocyclic brands
• Faster margin degradation than absolute volume growth in competitive periods

For GADAVIST specifically, the pattern is consistent with a “volume-led, price-constrained” profile driven by hospital contracting.

Where do margins and cash flow typically land for this category?

Channel economics

GBCA manufacturers face:

• Distributor markups and rebate structures
• Healthcare procurement compliance costs
• Pharmacovigilance and risk-management spend tied to GBCA labeling

As a result, operating margin trends usually track:

• Net price per dose after rebates
• Volume stability and inventory turns
• Manufacturing and distribution efficiency

What are the main risks to GADAVIST’s commercial outlook?

1) Contract pricing volatility

• Net price changes with each major hospital or GPO tender cycle.

2) Substitution within the macrocyclic class

• DOTAREM and PROHANCE can take utilization share if priced or positioned better in contracts.

3) Regulatory and safety posture tightening

• Any further label restrictions around gadolinium deposition, dosing, or patient selection can dampen use.

4) Supply disruptions

• GBCA demand is “must-serve” for imaging schedules; shortages can force temporary loss of utilization.

What are the main upside levers?

1) MRI utilization growth

• Increased MRI volume expands addressable GBCA doses.

2) Protocol standardization favoring macrocyclic agents

• Continued shift away from linear GBCAs supports macrocyclic demand.

3) Contract re-positioning

• Improved pricing discipline or stronger supply reliability can regain tender-based share.

4) Expanded use cases

• Growth in contrast-enhanced protocols for neurologic and oncology indications increases per-patient use.

Key Takeaways

• Market is hospital-contract driven: GADAVIST’s financial trajectory is shaped more by tenders and formulary allocation than by incremental clinical differentiation.
• Macrocyclic preference supports baseline demand: Institutional safety governance generally favors macrocyclic agents, supporting gadobutrol.
• Pricing compression risk is structural: Net price per dose tends to move at tender cycles within the macrocyclic competitive set.
• Financial outcomes follow MRI volume with downside from contract pressure and share shifts: Revenue growth can be volume-led but constrained by rebate and pricing resets.

FAQs

1) Is GADAVIST a macrocyclic gadolinium-based contrast agent?
Yes. GADAVIST contains gadobutrol, a macrocyclic GBCA used for MRI contrast enhancement.

2) What main competitors pressure GADAVIST in MRI contrast?
Macrocyclic GBCA brands such as DOTAREM (gadoterate meglumine) and PROHANCE (gadoteridol) compete directly in hospital formularies.

3) How do hospital procurement processes affect GADAVIST’s financial results?
Net revenue is heavily influenced by GPO contracts and hospital tenders, which can re-set pricing and utilization allocation among competing GBCA brands.

4) What demand drivers matter most for GADAVIST?
MRI procedure volume and uptake of contrast-enhanced protocols drive dosing demand, while patient selection protocols influence usage patterns.

5) What are the largest risks to the product’s outlook?
Contract pricing volatility, substitution within the macrocyclic set, and any further regulatory tightening around gadolinium retention risk.

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References (APA)

[1] FDA. (2020). Information by Drug Class: Gadolinium-based Contrast Agents (GBCAs). U.S. Food and Drug Administration. https://www.fda.gov/
[2] European Medicines Agency. (n.d.). Gadobutrol-containing medicinal products: product information and assessment reports. EMA. https://www.ema.europa.eu/
[3] World Health Organization. (n.d.). Gadolinium-based contrast agents: safety communications and reports. WHO. https://www.who.int/