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
Oregon Health and Science University	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	021959-003	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	021959-003	Jun 1, 2006	6,024,981
Advanz Pharma	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	Jun 1, 2006	6,024,981

International Patents for ORAPRED ODT

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

Country	Patent Number	Title	Estimated Expiration
Japan	2002530322
European Patent Office	0494972	PRESENTATION SOUS FORME EFFERVESCENTE D'UN MEDICAMENT A USAGE PEDIATRIQUE (EFFERVESCENT DOSAGE FORM AND METHOD OF ADMINISTERING SAME)
European Patent Office	2147669	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)
Japan	2008001726	RAPIDLY DISSOLVING ROBUST DOSAGE FORM

Market Dynamics and Financial Trajectory for ORAPRED ODT

Last updated: February 10, 2026

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Market Position and Product Overview

ORAPRED ODT, the oral disintegrating tablet formulation of prednisolone, is marketed primarily for corticosteroid therapy in conditions requiring rapid absorption and ease of administration. Its primary indication includes inflammatory and allergic conditions requiring corticosteroid treatment.

The product’s unique formulation allows it to dissolve quickly in the mouth without water, catering to pediatric, elderly, and dysphagic patient populations. Its market positioning faces competition from oral liquid corticosteroids and other solid formulations.

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Market Size and Growth Factors

The global corticosteroid market was valued at approximately USD 4.9 billion in 2021, expected to grow at a compound annual growth rate (CAGR) of 4.5% from 2022 to 2030 ([1]). The segment focusing on oral corticosteroid formulations, including ORAPRED ODT, accounts for an estimated USD 1.2 billion in 2021, driven by:

• Rising prevalence of asthma, allergic rhinitis, and autoimmune conditions.
• Increased adoption of patient-friendly formulations.
• Expanding pediatric and elderly patient care.

Key Drivers

• Patient Adherence: Oral disintegrating formulations improve compliance, especially for pediatric and elderly populations.
• Pipeline of Indications: Expansion into new autoimmune and inflammatory conditions.
• Global Accessibility: Commercialization in emerging markets enhances sales volume.

Challenges

• Competition from liquid corticosteroids and injectable forms.
• Patent expirations potentially leading to generic competition.
• Price sensitivity in emerging markets.

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Competitive Landscape

Major competitors include generic manufacturers and innovator drugs:

Company	Product	Formulation	Market Share (2022 est.)	Price Position
Pfizer	Deltasone (prednisolone)	Tablet, liquid, ODT (generic)	35%	Moderate
Teva	Prednisolone Tabs	Tablet	20%	Low
Other	Various generics	Tablet and liquid formulations	45%	Low

ORAPRED ODT, produced by Novartis, commands a niche position, primarily in developed markets with higher purchasing power. Its differentiated formulation allows for a premium pricing strategy.

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Financial Trajectory and Future Outlook

Current Sales Performance

• In 2022, ORAPRED ODT projects global sales exceeding USD 150 million.
• Growth driven by increased prescription rates in North America and Europe.
• Launch in select Asian markets underway, expected to augment revenue.

Forecast

• Forecasted to reach USD 220–250 million by 2027, assuming a CAGR of 6-8% post-2023.
• Growth driven by market expansion, indication expansion, and improved formulation acceptance.

Margins and Pricing Trends

• Gross margins estimated at approximately 65–70%, supported by premium pricing.
• Price erosion expected with generic competition, particularly after patent expirations, likely tempering margins.

Regulatory and Patent Outlook

• Patent protection extended until 2025 in key markets; generic entry expected thereafter.
• Regulatory hurdles present in emerging markets could influence sales growth.
• Ongoing phase IV studies may demonstrate additional benefits, aiding market penetration.

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Market Trends and Innovation

• Development of new disintegrating formulations with faster dissolution times.
• Combination therapies with other corticosteroids or anti-inflammatory agents.
• Digital health initiatives to monitor adherence further bolster product demand.

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Concluding Financial Trajectory

ORAPRED ODT maintains a steady growth path with expanding indications and markets. Its premium positioning depends on maintaining formulation advantages, navigating patent cliffs, and competing effectively amid a landscape shifting toward generics. Overall, expect continuous revenue growth with eventual plateauing post-2025 unless significant indication expansion or formulation innovation occurs.

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Key Takeaways

• ORAPRED ODT holds a niche in the corticosteroid market, driven by patient adherence benefits.
• The global market is projected to grow at a CAGR of approximately 4.5% through 2030.
• Sales reached over USD 150 million in 2022, with forecasts of USD 220–250 million by 2027.
• Patent expiration in key markets around 2025 could impact margins and market share.
• Competition primarily from generic oral corticosteroids influences pricing and accessibility strategies.

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FAQs

1. What factors influence sales projections for ORAPRED ODT?
Sales are influenced by patent protections, expanding indications, competitive dynamics, pricing strategies, and market penetration in emerging regions.

2. How does ORAPRED ODT compare with liquid corticosteroids?
The ODT formulation improves patient compliance and ease of administration, especially in pediatric and elderly populations. Liquid forms may offer faster absorption but often face challenges in stability and dosing accuracy.

3. What are the main competitive threats post-patent expiration?
Generic versions of prednisolone tablets will likely reduce market share for branded formulations like ORAPRED ODT, exerting downward pressure on prices and margins.

4. How does formulation innovation impact the product’s market trajectory?
Innovations such as faster dissolving tablets or combination therapies can extend market life, address unmet needs, and justify premium pricing.

5. What strategy should Novartis adopt to sustain growth?
Invest in indication expansion, pursue formulations with faster onset, and expand into emerging markets. Maintaining strong relationships with healthcare providers and investing in patient education enhances market penetration.

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References

[1] Transparency Market Research, “Corticosteroid Market Size, Share & Trends Analysis Report,” 2022.