RIDAURA Drug Patent Profile

Which patents cover Ridaura, and what generic alternatives are available?

Ridaura is a drug marketed by Legacy Pharma and is included in one NDA.

The generic ingredient in RIDAURA is auranofin. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the auranofin profile page.

Summary for RIDAURA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	7
Patent Applications:	2
Drug Prices:	Drug price information for RIDAURA
What excipients (inactive ingredients) are in RIDAURA?	RIDAURA excipients list
DailyMed Link:	RIDAURA at DailyMed

See drug prices for RIDAURA

Recent Clinical Trials for RIDAURA

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

Sponsor	Phase
Mayo Clinic	Phase 2
National Cancer Institute (NCI)	Phase 2
Mayo Clinic	Phase 1

See all RIDAURA clinical trials

US Patents and Regulatory Information for RIDAURA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Legacy Pharma	RIDAURA	auranofin	CAPSULE;ORAL	018689-001	May 24, 1985		RX	Yes	Yes

Expired US Patents for RIDAURA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Legacy Pharma	RIDAURA	auranofin	CAPSULE;ORAL	018689-001	May 24, 1985
Legacy Pharma	RIDAURA	auranofin	CAPSULE;ORAL	018689-001	May 24, 1985
Legacy Pharma	RIDAURA	auranofin	CAPSULE;ORAL	018689-001	May 24, 1985
Legacy Pharma	RIDAURA	auranofin	CAPSULE;ORAL	018689-001	May 24, 1985
Legacy Pharma	RIDAURA	auranofin	CAPSULE;ORAL	018689-001	May 24, 1985

International Patents for RIDAURA

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

Country	Patent Number	Title	Estimated Expiration
Belgium	757672
Canada	959483	TRIALKYLPHOSPHINEGOLD COMPLEXES OF 1-(BETA)-D-GLUCOPYRANOSIDES
Switzerland	543543	Verfahren zur Herstellung von Trialkylphosphingoldkomplex-Verbindungen von 1-B-D-Glukopyranosiden bzw. 1-Thio-B-D-glukopyranosiden bzw. 1-Thio-B-D-glukopyranosen
Germany	2051495
Denmark	129847
Denmark	130306

Market Dynamics and Financial Trajectory for RIDAURA (Auranofin)

Last updated: January 26, 2026

Executive Summary

RIDAURA (auranofin) is an oral gold-based disease-modifying anti-rheumatic drug (DMARD) primarily approved for the treatment of rheumatoid arthritis (RA). While initially a mainstay in RA therapy, its market presence has diminished due to the advent of biologic agents and targeted synthetic DMARDs. This report analyzes the current market landscape, key growth drivers, competitive environment, regulatory factors, and future financial prospects for RIDAURA.

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Overview of RIDAURA (Auranofin)

Attribute	Details
Generic Name	Auranofin
Brand Name	RIDAURA
Approval Date	1985 (FDA)
Indication	Rheumatoid arthritis (RA) (predominantly)
Mechanism of Action	Gold compound modulating immune response, anti-inflammatory effects
Formulation	Oral capsules (6 mg)
Market Status	Limited; phased out in some regions due to newer therapies

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Market Dynamics

1. Historical Market Position

Historically, RIDAURA was among the first oral DMARDs approved for RA, serving as an alternative to injectable gold compounds. Its early adoption was driven by the convenience of oral administration and significant efficacy in RA management.

2. Decline in Market Share

The advent of biologic DMARDs (e.g., infliximab, etanercept) and Janus kinase (JAK) inhibitors (e.g., tofacitinib) significantly reduced RIDAURA’s market share. Key factors include:

• Efficacy and Safety Profile: Biologics exhibit superior efficacy and safety profiles in many RA cases.
• Manufacturing and Compliance: Gold compounds require monitoring for gold toxicity, impacting adherence.
• Market Penetration: Shift toward personalized medicine and targeted therapies has limited long-term relevance of older drugs like RIDAURA.

3. Prescription Trends

Recent U.S. prescription data indicates a decline in Auranofin prescriptions from approximately 1 million prescriptions annually in the 1990s to near negligible levels today, reflecting the drug’s obsolescence in developed markets.

4. Geographical Market Dynamics

Region	Market Status	Drivers	Barriers
North America	Declining	Biologics dominate, patent expiries	Limited demand
Europe	Limited	Similar to North America	Reimbursement challenges
Emerging Markets	Potential	Gold-based treatments still used	Regulatory limitations, safety concerns

Note: RIDAURA remains prescribed in some low-resource settings and off-label for certain parasitic infections, but these are niche markets.

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Competitive Landscape

Key Competitors	Type	Market Share	Distinctive Features
Biologic DMARDs (e.g., Humira, Enbrel)	Monoclonal antibodies	Dominant in RA	High efficacy, targeted mechanisms
JAK inhibitors (e.g., Xeljanz)	Small molecules	Growing, substantial	Oral, convenient, rapid onset
Other gold compounds	Older DMARDs	Very limited	Similar mechanism, less favored
Emerging Therapies	Biosimilars, novel agents	Increasing	Cost advantages, improved safety

1. Market Share Distribution

Segment	Estimated Market Share (2022)	Comments
Biologics	75%	Leading in RA treatment globally
JAK Inhibitors	20%	Rapid growth, oral administration
Traditional DMARDs (Methotrexate, Gold compounds)	5%	Mostly residual use

2. Pricing and Reimbursement

Pricing Tier	Typical Cost (US)	Reimbursement Likelihood	Notes
Gold Compounds	$50 - $100/month	Low	Off patent, generic options available
Biologics	$2,000 - $4,000/month	Variable	High-cost, insurance-dependent
JAK inhibitors	$1,500 - $3,000/month	Variable	Increasing accessibility

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Regulatory and Policy Environment

1. Regulatory Status and Approvals

• FDA: RIDAURA approved in 1985 for RA.
• Global Approvals: Limited approvals outside US and EU; some countries permit off-label uses.
• Post-Marketing Surveillance: Gold-based drugs increasingly scrutinized for toxicity, especially nephrotoxicity, hematologic adverse effects.

2. Guidelines and Clinical Adoption

• Major rheumatology guidelines (ACR 2021, EULAR 2022) recommend biologics and JAK inhibitors as first-line after methotrexate failure.
• Gold remains a secondary or reserve therapy, mainly in resource-limited settings.

3. Reimbursement Policies

• Payers favor newer, more effective agents.
• Reimbursement for RIDAURA significantly declines, affecting manufacturers' incentives.

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Financial Trajectory Analysis

1. Revenue Projections

Year	Estimated Global Revenue	Key Drivers	Assumptions
2022	<$10 million	Minor niche use	Decline continues, minimal growth
2025	<$5 million	Off-label niche	Further erosion in developed markets
2030	Near zero	Obsolescence	Limited residual demand

2. Manufacturing and Market Entry Costs

Cost Aspect	Estimates	Implication
Development	N/A	Not pursued due to obsolescence
Manufacturing	Low, generic-like	Minimal if produced
Marketing	Negligible	Limited due to declining market

3. Potential for Market Rebound

• Possible in niche markets for rare conditions or in countries with limited access to biologics.
• Requires formulation optimization or new indications.

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Comparative Analysis: RIDAURA vs. Competing Therapies

Attribute	RIDAURA (Auranofin)	Biologics	JAK Inhibitors
Mechanism	Gold compound	Monoclonal antibodies	Small molecule kinase inhibitors
Efficacy	Moderate	High	High
Safety Profile	Gold toxicity risks	Variable	Similar to other small molecules
Administration	Oral	Injectable	Oral
Cost	Low	High	High
Market Decline	Yes	No	Growing

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Key Market Opportunities and Risks

Opportunities	Risks
Niche application in resource-limited regions	Falling out of favor due to safety and efficacy concerns
Off-label uses for parasitic conditions	Regulatory restrictions and safety issues
Development of new formulations or combinations	Market obsolescence

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FAQs

1. Why has the market for RIDAURA declined significantly?

The primary reasons include the superior efficacy, safety, and convenience of biologic and targeted synthetic DMARDs, leading to minimal prescribing of gold compounds like RIDAURA in developed regions.

2. Are there any future prospects for RIDAURA?

Limited. Its market is now niche, mainly in developing countries or specific off-label indications. Significant growth or repurposing faces scientific and economic barriers.

3. How do safety concerns affect RIDAURA's market?

Gold-based therapies pose risks of toxicity, including nephrotoxicity and hematologic adverse effects, reducing clinician willingness to prescribe.

4. Is RIDAURA still approved in any markets?

Yes, it remains approved in the US and some countries but with declining prescription rates. Some markets may permit off-label uses.

5. Could formulation innovations revitalize RIDAURA?

Unlikely, unless new data demonstrates improved safety or expanded indications. The current trend favors newer agents.

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Key Takeaways

• Market Status: RIDAURA’s role in RA treatment has diminished due to competition from biologics and JAK inhibitors.
• Revenue Outlook: Marginal with near-zero projections beyond the next few years, primarily driven by niche applications.
• Regulatory and Market Trends: Shift toward targeted therapies limits future growth; safety concerns hinder revival.
• Strategic Implications: Companies interested in RIDAURA should consider niche or off-label markets rather than mainstream RA therapy.

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References

1. [1] U.S. Food and Drug Administration (FDA), RIDAURA approval history, 1985.
2. [2] Rheumatology Guidelines, American College of Rheumatology (ACR) 2021.
3. [3] European League Against Rheumatism (EULAR), RA treatment recommendations, 2022.
4. [4] Prescription data, IQVIA, 2022.
5. [5] Market Research Future, "Global Gold-based Drugs Market," 2021.