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, Amneal, Lupin Ltd, Sun Pharma Canada, Allergan, Alcon, Pharmafair, Novartis, and Bausch And Lomb, and is included in twenty-nine 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. Ten suppliers are listed for this compound.

Summary for PREDNISOLONE ACETATE

International Patents:	11
US Patents:	1
Tradenames:	18
Applicants:	17
NDAs:	29
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	114
Patent Applications:	6,724
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
Research Insight LLC	PHASE4
Astellas Pharma Global Development, Inc.	PHASE2
Maanasa Indaram, MD	PHASE1

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
Abbvie	PRED MILD	prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	017100-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Bausch And Lomb	SULPHRIN	prednisolone acetate; sulfacetamide sodium	SUSPENSION/DROPS;OPHTHALMIC	088089-001	Dec 28, 1982		DISCN	No	No
Watson Labs	PREDNISOLONE ACETATE	prednisolone acetate	INJECTABLE;INJECTION	083398-001	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
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008	6,071,523
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008	5,881,926
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008	6,102,254

International Patents for PREDNISOLONE ACETATE

Country	Patent Number	Title	Estimated Expiration
Japan	2009503097
Australia	2006278620	Oral suspension of prednisolone acetate
Japan	2013014634	ORAL SUSPENSION OF PREDNISOLONE ACETATE

Market Dynamics and Financial Trajectory for Prednisolone Acetate

Last updated: February 19, 2026

What is the Current Market Size and Growth Rate?

Prednisolone acetate is a corticosteroid primarily used as an ophthalmic suspension for inflammation and allergic conditions of the eye.

• Global ophthalmic corticosteroid market was valued at approximately USD 600 million in 2022.
• The compound-specific segment, including prednisolone acetate, accounts for about 55% of this market.
• Compound annual growth rate (CAGR) for the ophthalmic corticosteroid segment from 2023 to 2028 is expected to be around 4.5% (Research and Markets, 2023).

How Are Regulatory and Patent Landscapes Shaping the Market?

Patent Status

• Several patents for formulations and delivery methods of prednisolone acetate expired between 2018 and 2020.
• Newer patents focus on sustained-release formulations and preservative-free derivatives, extending exclusivity until 2030 in major markets (FDA, EMA).

Regulatory Environment

• Classified as a prescription drug with established safety profiles.
• Approved in multiple regions; no upcoming major regulatory hurdles anticipated for existing formulations.
• Generic entry is ongoing, which is pressuring branded prices.

What Are the Key Drivers and Barriers?

Drivers

• Increasing prevalence of ophthalmic inflammatory diseases, projected to grow at 5% annually.
• Technological advances in drug delivery, improving adherence and outcomes.
• Aging populations globally heightening demand for eye care solutions.

Barriers

• Market saturation with generics reducing profit margins.
• Price competition from biosimilar and generic competitors.
• Conservative prescribing habits limiting growth in some regions.

What Are the Main Geographic Market Trends?

Region	Market Size (USD million, 2022)	CAGR (2023-2028)	Notes
North America	225	4.0%	High adoption, extensive insurance coverage
Europe	150	4.2%	Strong ophthalmic care infrastructure
Asia-Pacific	120	6.0%	Rapid market expansion, rising aging population
Latin America	45	3.8%	Growing eye care awareness

What Are Revenue and R&D Trends?

• The base market generated approximately USD 600 million in 2022.
• Branded product sales account for 60%, with generics comprising the remaining 40%.
• R&D investments for novel formulations (e.g., sustained release) have increased, with 15 new patents filed globally between 2020 and 2022.
• Expected R&D expenditure for new formulations: USD 30 million annually over the next 5 years.

How Is Pricing Trending?

• Average wholesale price (AWP) for branded prednisolone acetate ophthalmic suspension hovers around USD 15 per 15 mL bottle.
• Generic prices have reduced by approximately 30% since 2018.
• Price pressure is likely to persist due to increasing generic competition.

What Are Market Entry and Competition Strategies?

• Companies are investing in patient-friendly formulations, such as preservative-free drops.
• Focus is on developing sustained-release implants to increase adherence.
• Strategic licensing agreements to expand access in emerging markets.

What Is the Outlook for Market Consolidation?

• Mergers and acquisitions are ongoing among mid-sized pharmaceutical companies to enhance R&D capabilities.
• Larger firms focus on portfolio diversification across ophthalmic drugs.
• Industry consolidation likely to intensify due to pricing pressures and regulatory shifts.

Summary of Financial Projections

Year	Estimated Market Size (USD million)	Key Factors
2023	USD 630 million	Continued generic erosion, stable demand
2025	USD 680 million	Adoption of new formulations, aging populations
2028	USD 800 million	Growth in emerging markets, technological advances

Key Takeaways

• The prednisolone acetate ophthalmic market is expanding modestly, bolstered by aging demographics and technological innovation.
• Patent expiries have led to increased generic competition, reducing prices.
• R&D focus on improved delivery systems may provide patent protection and differentiation.
• Market growth remains constrained by pricing pressures and high generic penetration.
• Asia-Pacific and Latin America present growth opportunities due to demographic trends.

FAQs

1. What are the main clinical uses of prednisolone acetate?
   It treats inflammation and allergic reactions in the eyes, such as uveitis and post-operative inflammation.

2. Are there significant patent protections still in place?
   Most patents expired between 2018 and 2020 but are being replaced by newer patents on advanced formulations.

3. How does generic competition impact pricing?
   It drives prices down; generic versions are priced approximately 30% lower than branded products.

4. What emerging formulations could disrupt the market?
   Sustained-release implants and preservative-free drops aim to improve adherence and reduce dosing frequency.

5. Which markets offer the highest growth potential?
   The Asia-Pacific region exhibits the fastest growth, driven by aging populations and expanding healthcare infrastructure.

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References

[1] Research and Markets. (2023). Global Ophthalmic Corticosteroids Market Analysis.

[2] U.S. Food and Drug Administration. (2022). Approved Ophthalmic Formulations.

[3] European Medicines Agency. (2022). Market Authorization Data.