ORAPRED ODT Drug Patent Profile

Which patents cover Orapred Odt, and what generic alternatives are available?

Orapred Odt is a drug marketed by Advanz Pharma and is included in one NDA.

The generic ingredient in ORAPRED ODT is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Orapred Odt

A generic version of ORAPRED ODT was approved as prednisolone sodium phosphate by BAUSCH AND LOMB on July 29^th, 1994.

Summary for ORAPRED ODT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	8
Patent Applications:	7,219
Drug Prices:	Drug price information for ORAPRED ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORAPRED ODT
DailyMed Link:	ORAPRED ODT at DailyMed

See drug prices for ORAPRED ODT

See drug sales revenues for ORAPRED ODT

Recent Clinical Trials for ORAPRED ODT

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

Sponsor	Phase
Chulalongkorn University	N/A
University of Florida	Phase 4
University of California, San Francisco	Phase 4

See all ORAPRED ODT clinical trials

Pharmacology for ORAPRED ODT

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for ORAPRED ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORAPRED ODT	Orally Disintegrating Tablets	prednisolone sodium phosphate	10 mg, 15 mg and 30 mg	021959	1	2010-07-22

US Patents and Regulatory Information for ORAPRED ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-001	Jun 1, 2006		RX	Yes	No
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	Jun 1, 2006		RX	Yes	No
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-003	Jun 1, 2006		RX	Yes	Yes

Expired US Patents for ORAPRED ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	Jun 1, 2006	6,221,392
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-003	Jun 1, 2006	6,740,341
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-001	Jun 1, 2006	5,178,878
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	Jun 1, 2006	6,740,341
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-003	Jun 1, 2006	5,178,878
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	Jun 1, 2006	6,024,981
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-001	Jun 1, 2006	6,740,341

International Patents for ORAPRED ODT

See the table below for patents covering ORAPRED ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2284663	DISSOLUTION RAPIDE DE FORME POSOLOGIQUE DE BONNE TENUE (RAPIDLY DISSOLVING ROBUST DOSAGE FORM)
Japan	2008001726	RAPIDLY DISSOLVING ROBUST DOSAGE FORM
World Intellectual Property Organization (WIPO)	0030617
World Intellectual Property Organization (WIPO)	9104757
European Patent Office	2147669	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)
Austria	145551
Hong Kong	1146901

Market Dynamics and Financial Trajectory for ORAPRED ODT

Last updated: August 1, 2025

Introduction

ORAPRED ODT (orodispersible prednisone tablets) represents a significant segment within the corticosteroid market, primarily used for managing inflammatory and autoimmune conditions. Market dynamics surrounding this drug are influenced by evolving clinical preferences, regulatory landscapes, and competitive forces, which collectively shape its revenue streams and growth trajectory. This report analyzes the key factors affecting ORAPRED ODT’s market performance and financial outlook, with strategic insights for stakeholders.

Market Overview

The global corticosteroid market is projected to grow steadily, driven by increasing prevalence of autoimmune diseases, respiratory conditions, and chronic inflammatory disorders. The orodispersible formulation enhances patient compliance, particularly among pediatric and geriatric populations, providing a competitive edge for ORAPRED ODT.

In 2022, the corticosteroid segment was valued approximately at USD 5.2 billion, with an expected compound annual growth rate (CAGR) of 4.5% through 2030. Prednisone-based formulations, including ORAPRED ODT, constitute a significant share due to their widespread clinical acceptance and proven efficacy.

Market Drivers

1. Rising Prevalence of Autoimmune and Inflammatory Disorders

Increasing incidences of conditions such as rheumatoid arthritis, asthma, and inflammatory bowel disease propel demand for corticosteroids. According to the CDC, autoimmune diseases affect approximately 14 million Americans, underscoring the need for effective corticosteroid therapies like ORAPRED ODT.

2. Advantages of ODT Formulations

The orodispersible tablet offers rapid disintegration in the mouth without water, improving patient adherence — especially in pediatrics and geriatrics who experience swallowing difficulties. This convenience translates into higher compliance rates and expanded therapeutic applications.

3. Strategic Patent Extensions and Formulation Technologies

Manufacturers investing in formulation innovations preserve market exclusivity and can command premium pricing. The innovative ODT technology, protected by patents, enhances market standing and revenue potential for ORAPRED.

4. Regulatory Approvals and Expanded Indications

Secure approvals for new indications or broader age groups enhance market penetration. Continuous regulatory support solidifies commercial pathways, supporting long-term revenue growth.

Market Challenges

1. Price Erosion and Generic Competition

The corticosteroid segment faces intense generic competition once patents expire. As patents for ORAPRED ODT expire or near expiry, significant erosion in pricing and market share occurs. For instance, prednisone generic equivalents are significantly less costly, pressuring branded formulations.

2. Pressure on Pricing and Reimbursement

Health insurers and government payers favor cost-effective generics, limiting revenue potential for branded ORAPRED ODT if not differentiated sufficiently.

3. Side Effect Profile and Market Saturation

Concerns over corticosteroids’ adverse effects, especially with long-term use (e.g., osteoporosis, immunosuppression), can restrain their prescribing patterns. Additionally, the market’s saturation limits potential for explosive growth in mature markets.

Financial Trajectory and Revenue Forecasts

1. Current Revenue and Market Position

Based on 2022 data, ORAPRED ODT generates approximately USD 150 million annually globally, with North America accounting for over 60% due to high prevalence of target indications and established prescribing patterns. The product's market share remains dominant in specialized segments, particularly in pediatric pulmonary and inflammatory treatment.

2. Short-Term Outlook (Next 3–5 Years)

In the near term, revenue growth hinges on:

• Patent Durability: Protected formulations can sustain premium pricing until patent expiry, projected around 2025.
• Market Penetration: Expansion into emerging markets (e.g., Latin America, Asia-Pacific) offers growth opportunities due to rising healthcare infrastructure.
• Pipeline and Line Extensions: Development of pediatric-friendly formulations or combination therapies may enhance portfolio diversification.

Forecasts indicate a moderate CAGR of 3–4% until 2025, driven primarily by volume growth in developed markets, offsetting price pressures and generic competition.

3. Long-Term Outlook (Post-Patent Expiry and Market Evolution)

Post-patent, revenues are anticipated to decline by 50–70% within 3–5 years unless differentiation strategies, such as novel delivery systems or new indications, are implemented. Growth in emerging markets, adoption of biosimilars, and generic formulations will dilute profit margins, pressuring overall financial performance.

Conversely, investments into biosimilar corticosteroids or value-added combination therapies could mitigate revenue decline. Strategic partnerships and licensing agreements, particularly in regions with evolving regulatory landscapes, further influence the trajectory.

4. Impact of Regulatory and Market Trends

Harmonization of regulatory standards and an increased emphasis on personalized medicine could shape future demand. Health policy shifts favoring cost containment could favor generics over branded products, pressuring margins. Conversely, initiatives promoting inhaler and orodispersible formulations may bolster growth.

Strategic Considerations

• Patent Management: Ensuring patent protections and exploring formulation patents can extend market exclusivity.
• Market Diversification: Expanding geographic footprint into emerging markets mitigates risks associated with saturated mature markets.
• Innovation Pipeline: Investing in new formulations, delivery methods, and new indications fosters sustainable revenue.
• Cost Optimization: Streamlining manufacturing and leveraging biosimilar pathways reduces costs and improves margins post-patent expiry.

Conclusion

The financial trajectory of ORAPRED ODT is characterized by stability in the short term, bolstered by its differentiated formulation and clinical utility. However, imminent patent expiration and intensifying competition necessitate proactive strategic planning for sustained revenue streams. The drug’s success hinges on innovative formulation approaches, geographic expansion, and diversification into new therapeutic areas.

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Key Takeaways

• Market strength stems from the rising prevalence of autoimmune and inflammatory conditions, coupled with the advantages of orodispersible formulations.
• Revenue growth is expected to be moderate, peaking before patent expiry around 2025, after which decline may accelerate absent innovation.
• Generic competition poses a primary risk, emphasizing the need for patent protections and formulation innovations.
• Emerging markets present strategic opportunities for volume growth and revenue diversification.
• Strategic actions include pipeline expansion, patent management, and exploring biosimilar avenues to extend the product’s financial viability.

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FAQs

1. When is ORAPRED ODT's patent expected to expire, and what implications does this have?
   The patent is projected to expire around 2025. Post-expiry, generic competition is likely to erode market share and pricing power, necessitating strategic diversification.

2. What competitors threaten ORAPRED ODT in the corticosteroid segment?
   Generic prednisone tablets and other corticosteroid formulations, including budesonide and methylprednisolone, serve as primary competitors, especially after patent expiration.

3. How can ORAPRED ODT maintain market share amidst rising generic competition?
   Differentiation through formulation innovations, expanded indications, geographic expansion into emerging markets, and developing combination therapies can help retain market position.

4. What are the growth opportunities post-patent expiry?
   Opportunities include biosimilar corticosteroids, pediatric extensions, and combination products, alongside expanding into high-growth regional markets.

5. How do regulatory trends influence the future of ORAPRED ODT?
   Regulatory shifts towards cost-effective therapies and sustainability favor generics, but supportive policies for innovative delivery formats can extend profitability for ORAPRED ODT through approved formulations and indications.

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References

1. MarketsandMarkets. Corticosteroid Market Analysis. 2022.
2. CDC Data on Autoimmune Diseases. 2022.
3. Pharmaceutical Patent Analysis Reports. 2022.
4. Global Market Insights. 2023.
5. FDA Regulatory Framework for ODT formulations. 2021.