ORAPRED ODT Drug Patent Profile

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

Orapred Odt is a drug marketed by Concordia Pharms Inc 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. Fifteen 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:	36
Clinical Trials:	8
Patent Applications:	5,152
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
Winston Chamberlain, MD, PhD	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
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-001	Jun 1, 2006		RX	Yes	No
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	Jun 1, 2006		RX	Yes	No
Concordia Pharms Inc	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
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-003	Jun 1, 2006
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	Jun 1, 2006
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-003	Jun 1, 2006
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-001	Jun 1, 2006
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	Jun 1, 2006
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-003	Jun 1, 2006
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	Jun 1, 2006

International Patents for ORAPRED ODT

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

Country	Patent Number	Title	Estimated Expiration
Japan	3412694
Spain	2601855
Japan	2003231629	FOAMABLE DOSAGE FORM
Canada	2061917	FORME POSOLOGIQUE EFFERVESCENTE POUR ENFANTS (PEDIATRIC EFFERVESCENT DOSAGE FORM)
Spain	2097155
World Intellectual Property Organization (WIPO)	0030617
European Patent Office	2147669	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)

ORAPRED ODT Market Analysis and Financial Projection Experimental

Orally Disintegrating Tablets: The Market Dynamics and Financial Trajectory of Orapred ODT

Introduction to Orally Disintegrating Tablets (ODTs)

Orally disintegrating tablets (ODTs) have revolutionized the pharmaceutical industry by offering a convenient and patient-friendly alternative to traditional tablets. One notable example of an ODT is Orapred ODT, a product that utilizes advanced drug delivery technology to treat acute exacerbations of asthma in children.

Market Overview of ODTs

The global ODT market is experiencing significant growth, driven by several key factors. Here are some highlights:

• Market Size and Growth: The global ODT market is projected to grow from USD 13.2 billion in 2023 to USD 29.0 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 8.2% during the forecast period[1][4].
• Regional Dominance: North America leads the market, holding a substantial 36% market share and generating USD 8.1 billion in revenue in 2023. The Asia Pacific and Middle East & Africa regions are also expected to witness significant growth[1][4].

Orapred ODT: A Specific Case Study

Drug Delivery Technology

Orapred ODT utilizes CIMA LABS' innovative OraSolv® drug delivery technology. This technology allows the tablets to disintegrate quickly in the mouth without the need for water, making it easier for patients, especially children, to take their medication[2].

Clinical Use

Orapred ODT is primarily prescribed for acute exacerbations of asthma in children. It is an oral corticosteroid that provides quick relief and is available in a dissolving tablet form, which is particularly beneficial for pediatric patients who may struggle with swallowing traditional tablets[5].

Market Approval and Launch

The U.S. Food and Drug Administration (FDA) granted marketing approval for Orapred ODT, and it was expected to be marketed in the United States starting from the third quarter of 2006. This approval marked a significant milestone in the adoption of ODT technology for treating asthma[2].

Market Dynamics

Driving Factors

Several factors contribute to the growth of the ODT market, including:

• Increasing Prevalence of Dysphagia: The rising incidence of swallowing disorders makes ODTs a more appealing option for patients who struggle with traditional tablets[3].
• Technological Advancements: Continuous innovation in drug delivery technologies, such as those developed by CIMA LABS, enhances the efficacy and convenience of ODTs[2][4].
• Patient-Centric Healthcare: The growing emphasis on patient-centric healthcare solutions drives the demand for convenient and easy-to-administer medications like ODTs[4].

Competitive Landscape

The ODT market is diverse, featuring both established pharmaceutical giants and emerging companies. Key players include AstraZeneca, Mylan, Pfizer, Teva, Merck, and Johnson & Johnson, among others. These companies are actively involved in developing new formulations and expanding their product portfolios[1][3].

Distribution Channels

Hospital pharmacies currently hold a significant market share of 33% in the ODT market. However, online pharmacies and retail pharmacies are also gaining traction, offering patients more convenient access to ODTs[1].

Financial Trajectory

Revenue Projections

The success of Orapred ODT and similar ODT products contributes to the overall growth of the ODT market. Here are some financial projections:

• Global Market Size: Expected to reach USD 29.0 billion by 2033 from USD 13.2 billion in 2023[1].
• Regional Growth: The U.S. market for ODTs alone is expected to grow from USD 3.48 billion in 2023 to USD 8.42 billion by 2033, with a CAGR of 8.37%[4].

Impact of Generic Competition

The entry of generic competitors into the market can significantly reduce the prices of ODTs, making them more accessible to a wider patient population. This increased accessibility can lead to better health outcomes and higher medication adherence, ultimately benefiting both patients and healthcare systems[4].

Therapeutic Applications and Patient Benefits

Diverse Therapeutic Uses

ODTs, including Orapred ODT, are prescribed for a variety of conditions, including:

• Central Nervous System (CNS) Diseases: Conditions like depression, bipolar disorder, and schizophrenia benefit from ODTs due to their ease of administration[1][4].
• Respiratory Disorders: Orapred ODT specifically addresses acute exacerbations of asthma, providing quick relief and ease of use for pediatric patients[5].

Patient Adherence and Health Outcomes

The convenience and ease of use of ODTs can significantly improve patient adherence to medication regimens. This is particularly important for chronic conditions where consistent medication is crucial for managing symptoms and preventing complications.

Regional Growth and Market Diversity

Regional Expansion

The Asia Pacific region is expected to witness significant growth due to the increasing prevalence of chronic ailments and the growing emphasis on patient-centric healthcare solutions. Local and international businesses are investing heavily in the creation and production of new drugs, including ODTs, in this region[4].

Market Diversity

The ODT market features a diverse range of players, from established pharmaceutical companies to emerging entities. This diversity contributes to the market's growth and innovation, as companies continually develop new formulations and technologies to address unmet medical needs[1].

Key Takeaways

• Market Growth: The global ODT market is projected to grow significantly, driven by technological advancements and patient-centric healthcare solutions.
• Orapred ODT: Utilizes innovative drug delivery technology to treat acute exacerbations of asthma in children, highlighting the convenience and efficacy of ODTs.
• Financial Projections: The market is expected to reach USD 29.0 billion by 2033, with regional growth and generic competition playing key roles.
• Therapeutic Applications: ODTs are used for a variety of conditions, including CNS diseases and respiratory disorders, improving patient adherence and health outcomes.

FAQs

What is the primary use of Orapred ODT?

Orapred ODT is primarily prescribed for acute exacerbations of asthma in children, providing quick relief as an oral corticosteroid[5].

Which technology is used in Orapred ODT?

Orapred ODT uses CIMA LABS' OraSolv® drug delivery technology, which allows the tablets to disintegrate quickly in the mouth without the need for water[2].

What is the expected market size of the global ODT market by 2033?

The global ODT market is expected to reach around USD 29.0 billion by 2033[1].

What are the key driving factors of the ODT market?

The increasing prevalence of dysphagia, rising demand for on-the-go medication, and technological advancements in drug delivery are key driving factors[3].

How does generic competition affect the ODT market?

Generic competition reduces prices, making ODTs more accessible and increasing patient adherence, which can lead to better health outcomes and financial benefits for both patients and healthcare systems[4].

Sources

1. Market.us: Orally Disintegrating Tablet Market Outlook | CAGR of 8.2%
2. Biospace: CIMA LABS INC. Drug Delivery Technology Used In Orapred ODT(TM)
3. Business Research Insights: Orally Disintegrating Tablet (ODT) Market Growth at CAGR of 11.5%
4. Precedence Research: Orally Disintegrating Tablet Market Size to Hit USD 31.80 Bn by 2034
5. Asthma & Allergy Foundation of America: Prednisolone - Orapred ODT - Asthma & Allergy Foundation of America