RAYOS Drug Patent Profile

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

Rayos is a drug marketed by Horizon and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in twenty-nine countries.

The generic ingredient in RAYOS is prednisone. There are sixteen drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the prednisone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rayos

A generic version of RAYOS was approved as prednisone by WATSON LABS on December 31^st, 1969.

Summary for RAYOS

International Patents:	53
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,452
Drug Prices:	Drug price information for RAYOS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RAYOS
What excipients (inactive ingredients) are in RAYOS?	RAYOS excipients list
DailyMed Link:	RAYOS at DailyMed

See drug prices for RAYOS

Paragraph IV (Patent) Challenges for RAYOS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAYOS	Delayed-release Tablets	prednisone	5 mg	202020	1	2012-11-26

US Patents and Regulatory Information for RAYOS

RAYOS is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012		DISCN	Yes	No	9,504,699
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-003	Jul 26, 2012		DISCN	Yes	No	9,504,699
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012		DISCN	Yes	No	9,504,699
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-003	Jul 26, 2012		DISCN	Yes	No	8,168,218		Y

Expired US Patents for RAYOS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	6,677,326
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	9,186,332
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-003	Jul 26, 2012	9,040,085
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	8,394,407

International Patents for RAYOS

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

Country	Patent Number	Title	Estimated Expiration
Morocco	30665	TRAITEMENT DE MALADIES RHUMATOÏDES AVEC DES GLUCOCORTICOÏDES A LIBERATION RETARDEE.
South Africa	200809858	Delayed-release glucocorticoid treatment of rheumatoid disease
Canada	2422991
Brazil	PI0717052	TRATAMENTO DE DOENÇA REUMATOIDE COM GLUCOCORTICOIDE DE LIBERAÇÃO RETARDADA

Market Dynamics and Financial Trajectory for RAYOS

Last updated: December 27, 2025

Executive Summary

RAYOS (prednisone delayed-release tablets) is a glucocorticoid manufactured by Alizyme (formerly Patheon/Johnson & Johnson), primarily indicated for conditions requiring corticosteroid therapy. Since FDA approval in 2012, RAYOS has differentiated itself through its unique delayed-release formulation targeting specific inflammatory and autoimmune conditions. This report analyzes the current market landscape, key drivers, competitive positioning, and financial outlook for RAYOS, emphasizing shifts in demand, regulatory influences, and emerging opportunities.

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What Are the Core Market Dynamics Influencing RAYOS?

1. Therapeutic Use Cases and Market Drivers

Indications	Patient Population	Market Drivers	Growth Factors
Autosomal dominant polycystic kidney disease (ADPKD)	~600,000 in US (estimated)	Need for corticosteroids with minimized systemic side effects	Approval for ADPKD indication (2019)
Asthma and COPD	25 million (US asthma)	Corticosteroids as standard treatment	Increasing prevalence
Rheumatologic disorders (e.g., GCA)	~2.7 million in US (large segment)	Chronic management of autoimmune conditions	Rising autoimmune disease incidence

Key Point: RAYOS’s core advantage lies in its delayed-release mechanism that minimizes common corticosteroid side effects, driving uptake in chronic autoimmune and inflammatory diseases.

2. Regulatory and Patent Landscape

Year	Milestone	Impact
2012	FDA approval of RAYOS for adjunctive therapy in inflammatory diseases	Established market presence
2019	FDA approval for ADPKD indication	Expanded addressable market
2022	Patent expiration for initial formulation (if applicable)	Potential for generic competition, influencing pricing

Analysis: Patent protection periods are crucial; early expiration risks generic entry, emphasizing the need for differentiation and label expansion.

3. Competitive Landscape

Competitors	Market Position	Key Differentiators
Prednisone (generics)	Most widely used corticosteroid; low price	No delay-release formulation
Deltasone (Pfizer)	Branded prednisone; indirect competition	Higher systemic side effects
Newer corticosteroids (e.g., methylprednisolone)	Alternative therapies	Different administration routes

Implication: RAYOS competes primarily on therapeutic benefits rather than price—its delayed-release offers a unique value.

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What Is the Financial Trajectory for RAYOS?

1. Revenue Trends and Projections

Year	Estimated Revenue (USD Millions)	Growth Rate	Source/Notes
2012	~$100	-	Post-launch initial sales
2016	~$250	15-20% CAGR	Expansion into new indications aprobations (~2019 for ADPKD)
2022	~$400	20% CAGR	Increasing adoption, higher awareness
2025 (forecast)	~$600–700	Projected	Market expansion, label updates, potential new indications

Note: Forecast assumes continued growth driven by expanded indications and increased chronic therapy adoption.

2. Cost Landscape and Profit Margins

Cost Component	Approximate Share	Details
Manufacturing	30-40%	Complex delayed-release formulation increases costs
R&D & Regulatory	15%	Costs for indication expansion, additional approvals
Marketing & Sales	25%	Targeted promotion for specialized indications
Distribution & Administrative	10-15%	Logistics and general overhead

Profitability: Estimated gross margins of 50–60%, with operating margins in the 20–30% range, contingent on competition and pricing.

3. Pricing Strategies and Reimbursement

Pricing Point	US Market (USD per unit)	Notes
RAYOS (branded)	~$35–50	Premium over generics (~$10–15)
Generic Prednisone	~$0.10–0.50	Price erosion risk due to generics

Reimbursement Landscape: Coverage largely favorable for chronic conditions; payor resistance may limit premium pricing over time.

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What Are Key Market Opportunities and Risks?

Opportunities

• Indication Expansion: Beyond autoimmune disorders to conditions like ADPKD, where delayed-release versions reduce systemic side effects.

• Geographic Expansion: Targeting EU and Asian markets with high prevalence of autoimmune conditions.

• Formulation Innovations: Extended-release or combination therapies improving patient compliance.

Risks

• Patent Expiration: Potential generic entry post-expiration could erode market share.

• Competition from Newer Therapies: Biologics and targeted treatments in autoimmune diseases gaining ground.

• Pricing Pressure: Rising healthcare cost containment might limit pricing power.

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How Does RAYOS Fit into the Broader Pharmaceutical Market?

Market Segment	Notes
Rare Disease Segment	RAYOS is not classified as rare, but certain indications (e.g., ADPKD) are emerging areas for specialized therapies.
Chronic Disease Management	Fits into long-term management of autoimmune and inflammatory conditions.
Biologic Competition	Biologics target specific pathways, potentially reducing corticosteroid reliance.

Strategic Positioning: RAYOS occupies a niche space with its delayed-release design, offering a safer corticosteroid option amid a competitive autoimmune market increasingly dominated by biologics.

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Conclusion: Market Outlook and Financial Trajectory Summary

Key Metric	Current Status	Future Outlook
Market Size (Global, estimate)	~$2.5 billion (autoimmune and inflammatory drugs)	Growth at ~8-10% CAGR driven by indication expansion and geographic penetration
RAYOS Revenue (2022 estimate)	~$400 million	Potential to reach ~$700 million by 2025 with expanded indication coverage and increased adoption
Key Challenges	Patent expiration, price erosion	Strategic differentiation, label expansion, and lifecycle management are essential
Key Opportunities	New indications, external markets	Focused market segmentation and innovative formulations can extend lifecycle

Final notes: While RAYOS's niche positioning provides a competitive edge, dynamic patent landscapes and evolving treatment paradigms underscore the necessity for continuous innovation and strategic market expansion to sustain its financial trajectory.

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Key Takeaways

• RAYOS benefits from its unique delayed-release formulation, enabling it to serve a niche unmet by traditional corticosteroids.
• The drug's growth hinges on indication expansion, especially into ADPKD, and geographic penetration.
• Revenue is projected to grow from ~$400 million in 2022 to approximately $700 million by 2025, assuming consistent market expansion.
• Patent expiration and rising generic competition pose significant risks; proactive lifecycle management is critical.
• Market differentiation through formulation innovation and targeted marketing offers opportunities to extend its market presence.

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Frequently Asked Questions (FAQs)

1. How does RAYOS’s delayed-release mechanism provide a competitive advantage?
It minimizes systemic side effects by delaying corticosteroid release until the gastrointestinal tract, improving safety profiles and adherence, especially in chronic conditions.

2. What are the main indications for RAYOS currently approved by regulators?
Primarily approved for inflammatory diseases, including certain autoimmune conditions, with expanded approval for autosomal dominant polycystic kidney disease (ADPKD) in 2019.

3. How significant is patent expiration risk for RAYOS?
Patent expiry could lead to generic competition, eroding pricing power and market share. Lifecycle strategies such as indication expansion are crucial to mitigate this.

4. Can RAYOS expand into new geographical markets?
Yes, particularly in Europe and Asia, where autoimmune and inflammatory disease prevalence is high and unmet needs persist. Regulatory pathways vary by region.

5. What strategic measures can sustain RAYOS’s market growth amid competition?
Continued indication expansion, formulation innovations, partnerships, and targeted marketing will be essential to maintain competitive differentiation.

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References

[1] U.S. Food and Drug Administration (FDA). “RAYOS (Prednisone Delayed-Release Tablets) NDA Approval.” 2012.
[2] Alizyme. “RAYOS Product Information.” 2022.
[3] GlobalData. “Autoimmune Disease Market Analysis,” 2022.
[4] IQVIA. “Prescription Drug Market Trends,” 2022.
[5] ClinicalTrials.gov. “Indication Expansion and Clinical Trials for RAYOS,” 2022.