PREDNISOLONE ACETATE - Generic Drug Details

What are the generic drug sources for prednisolone acetate and what is the scope of freedom to operate?

Prednisolone acetate is the generic ingredient in eighteen branded drugs marketed by Schering, Bel Mar, Cent Pharms, Epic Pharma Llc, Watson Labs, Pfizer, Harrow Eye, Sandoz, Abbvie, Lupin Ltd, Taro, Allergan, Alcon, Pharmafair, Novartis, and Bausch And Lomb, and is included in twenty-eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Prednisolone acetate has eleven patent family members in nine countries.

There are eighteen drug master file entries for prednisolone acetate. Nine suppliers are listed for this compound.

Summary for PREDNISOLONE ACETATE

International Patents:	11
US Patents:	1
Tradenames:	18
Applicants:	16
NDAs:	28
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	106
Patent Applications:	6,251
Drug Prices:	Drug price trends for PREDNISOLONE ACETATE
Drug Sales Revenues:	Drug sales revenues for PREDNISOLONE ACETATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREDNISOLONE ACETATE
What excipients (inactive ingredients) are in PREDNISOLONE ACETATE?	PREDNISOLONE ACETATE excipients list
DailyMed Link:	PREDNISOLONE ACETATE at DailyMed

See drug prices for PREDNISOLONE ACETATE

See drug sales revenues for PREDNISOLONE ACETATE

Recent Clinical Trials for PREDNISOLONE ACETATE

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

Sponsor	Phase
Baoping XU	Phase 4
Wyse Eyecare	Phase 4
Salvat	Phase 3

See all PREDNISOLONE ACETATE clinical trials

Pharmacology for PREDNISOLONE ACETATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for PREDNISOLONE ACETATE

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AA	Corticosteroids, weak (group I)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XA	Corticosteroids, weak, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

S03BA	Corticosteroids
S03B	CORTICOSTEROIDS
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for PREDNISOLONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	OMNIPRED	prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	017469-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Harrow Eye	ECONOPRED	prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	017468-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Cent Pharms	PREDNISOLONE ACETATE	prednisolone acetate	INJECTABLE;INJECTION	084717-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for PREDNISOLONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008

International Patents for PREDNISOLONE ACETATE

Country	Patent Number	Title	Estimated Expiration
South Africa	200800926	ORAL SUSPENSION OF PREDNISOLONE ACETATE
China	101247786	Oral suspension of prednisolone acetate
European Patent Office	1909798	SUSPENSION ORALE D'ACETATE DE PREDNISOLONE (ORAL SUSPENSION OF PREDNISOLONE ACETATE)

PREDNISOLONE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prednisolone Acetate

Market Overview

Prednisolone acetate, a derivative of the corticosteroid prednisolone, is widely used to treat various inflammatory and allergic conditions. The market for prednisolone acetate has been experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The global prednisolone acetate market is anticipated to grow substantially over the forecast period from 2023 to 2031. According to market research, the market size is expected to increase at a CAGR of 3 to 5 percent, reaching an estimated valuation of several hundred million USD by 2031[4].

Segmentation

The market is segmented based on several criteria:

By Type

• Prednisolone acetate
• Methylprednisolone (though less commonly associated directly with acetate forms)[1].

By Application

• Eye drops and ointments for treating ocular inflammation and allergic reactions
• Oral solutions and tablets for systemic use in conditions like rheumatoid arthritis, Bell's palsy, and autoimmune hepatitis[3].

By Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle East and Africa[1][3].

Market Drivers

Several factors are driving the growth of the prednisolone acetate market:

Increasing Prevalence of Inflammatory and Allergic Conditions

The rising incidence of conditions such as rheumatoid arthritis, asthma, and allergic reactions is boosting the demand for corticosteroids like prednisolone acetate[3].

Expanding Geriatric Population

The elderly population is more prone to chronic inflammatory diseases, which in turn increases the demand for prednisolone acetate[3].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developing regions, are making these medications more accessible and contributing to market growth[1].

Market Restraints

Despite the growth, there are several challenges facing the market:

Side Effects and Safety Concerns

Long-term use of corticosteroids like prednisolone acetate can lead to significant side effects, which may deter some patients and healthcare providers[3].

Regulatory Hurdles

Stringent regulatory requirements and the need for continuous clinical trials to ensure safety and efficacy can slow down market growth[1].

Competitive Landscape

The prednisolone acetate market is highly competitive, with several key players:

Major Players

• Endo International
• Henan Lihua Pharmaceutical
• Mahima Life Sciences
• Symbiotec Pharma
• Wockhardt
• Pfizer
• Shandong Taihua Bio and Tech
• TEVA
• Pharmacia
• Xianju Pharma
• Sandoz
• Sanofi[3].

These companies are engaged in continuous research and development to improve product formulations and expand their market share.

Financial Performance

The financial performance of the prednisolone acetate market is robust, with significant revenue growth anticipated:

Revenue Projections

The market is expected to generate substantial revenue, with projections indicating a sustained and significant expansion from 2023 to 2031. The revenue is measured in USD million across various segments[1].

Pricing Analysis

The pricing of prednisolone acetate is moderately competitive, with the drug available in both brand and generic forms. Manufacturer and pharmacy coupons often help offset the cost, making it more accessible to a wider audience[3].

Regional Analysis

The market performance varies across different regions:

North America and Europe

These regions are expected to maintain a strong market presence due to advanced healthcare infrastructure and high awareness of corticosteroid treatments[1][3].

Asia-Pacific

This region is anticipated to show rapid growth due to increasing healthcare spending and a large patient population with inflammatory and allergic conditions[1][3].

Middle East and Africa

These regions are also expected to contribute to the market growth, albeit at a slower pace, due to improving healthcare facilities and increasing demand for corticosteroids[1][3].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the prednisolone acetate market:

Production and Supply Chain

The pandemic led to temporary disruptions in production and supply chains, affecting the availability of the drug in some regions[3].

Increased Demand

On the other hand, the pandemic increased the demand for corticosteroids due to their use in treating COVID-19-related inflammation and other secondary infections[3].

Key Takeaways

• Growing Demand: The market is driven by the increasing prevalence of inflammatory and allergic conditions.
• Competitive Landscape: The market is highly competitive with several major players.
• Financial Projections: Significant revenue growth is anticipated over the forecast period.
• Regional Variations: Market performance varies across regions, with North America and Europe leading and Asia-Pacific showing rapid growth.
• COVID-19 Impact: The pandemic has had both positive and negative impacts on the market.

FAQs

Q: What are the primary applications of prednisolone acetate?

A: Prednisolone acetate is primarily used to treat ocular inflammation and allergic reactions, as well as systemic conditions like rheumatoid arthritis and autoimmune hepatitis[3].

Q: Which regions are expected to drive the growth of the prednisolone acetate market?

A: North America, Europe, and the Asia-Pacific region are expected to be key drivers of market growth due to their advanced healthcare infrastructure and large patient populations[1][3].

Q: What are the major challenges facing the prednisolone acetate market?

A: The market faces challenges such as side effects and safety concerns associated with long-term corticosteroid use, as well as stringent regulatory requirements[3].

Q: Who are the key players in the prednisolone acetate market?

A: Key players include Endo International, Henan Lihua Pharmaceutical, Mahima Life Sciences, Symbiotec Pharma, and others[3].

Q: How has the COVID-19 pandemic affected the prednisolone acetate market?

A: The pandemic has led to temporary production and supply chain disruptions but has also increased demand due to its use in treating COVID-19-related conditions[3].

Sources

1. Market Research Intellect: Global API use Prednisolone Market Size, Trends and Projections.
2. Johnson & Johnson: 2021 First Quarter Sales of $22.3 Billion reflecting strong growth.
3. OpenPR: Prednisolone Market Share, Size, Demand, Key Players.
4. Market Research Intellect: Global Prednisolone Acetate Market Size And Forcast.
5. PR Newswire: Johnson & Johnson Reports 2021 First-Quarter Results.