Diflorasone diacetate - Generic Drug Details

What are the generic sources for diflorasone diacetate and what is the scope of freedom to operate?

Diflorasone diacetate is the generic ingredient in five branded drugs marketed by Ani Pharms, Avondale Pharms, Sun Pharma Canada, Pfizer, Taro Pharms North, Rising, Sciegen Pharms, and The J Molner, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for diflorasone diacetate. Two suppliers are listed for this compound.

Summary for diflorasone diacetate

US Patents:	0
Tradenames:	5
Applicants:	8
NDAs:	13
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	59
Drug Prices:	Drug price trends for diflorasone diacetate
What excipients (inactive ingredients) are in diflorasone diacetate?	diflorasone diacetate excipients list
DailyMed Link:	diflorasone diacetate at DailyMed

See drug prices for diflorasone diacetate

Pharmacology for diflorasone diacetate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for diflorasone diacetate

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for diflorasone diacetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	DIFLORASONE DIACETATE	diflorasone diacetate	OINTMENT;TOPICAL	207440-001	Feb 27, 2017	AB	RX	No	No
Ani Pharms	DIFLORASONE DIACETATE	diflorasone diacetate	CREAM;TOPICAL	076263-001	Dec 20, 2002		DISCN	No	No
Pfizer	PSORCON E	diflorasone diacetate	OINTMENT;TOPICAL	017994-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sciegen Pharms	DIFLORASONE DIACETATE	diflorasone diacetate	OINTMENT;TOPICAL	206572-001	Jul 24, 2015		DISCN	No	No

Expired US Patents for diflorasone diacetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FLORONE	diflorasone diacetate	CREAM;TOPICAL	017741-001	Approved Prior to Jan 1, 1982	3,980,778
Pfizer	FLORONE E	diflorasone diacetate	CREAM;TOPICAL	019259-001	Aug 28, 1985	3,980,778
Pfizer	PSORCON E	diflorasone diacetate	OINTMENT;TOPICAL	017994-001	Approved Prior to Jan 1, 1982	3,980,778
Pfizer	PSORCON	diflorasone diacetate	OINTMENT;TOPICAL	019260-001	Aug 28, 1985	3,980,778

Diflorasone diacetate Market Analysis and Financial Projection

Last updated: February 10, 2026

What Are the Market Dynamics Driving DIFLORASONE DIACETATE?

Difluprednate diacetate, marketed under brand names such as Flutomil, is an anti-inflammatory corticosteroid used primarily in dermatology and ophthalmology. Its market is influenced by several key factors.

Market Drivers

• Increasing Prevalence of Skin and Eye Conditions: Rising incidences of eczema, psoriasis, allergic conjunctivitis, and uveitis boost demand for corticosteroids. Global data indicates a 4.2% annual growth rate for dermatological conditions [1].

• Expanding Dermatology and Ophthalmology Markets: Rising healthcare access and aging populations worldwide expand treatment opportunities; Asia-Pacific markets expect compounded annual growth rates (CAGR) of approximately 6% over the next five years [2].

• Product Development and Licensing: Companies invest in formulation improvements for better tolerability and alternative delivery systems, maintaining market relevance.

Market Restraints

• Stringent Regulatory Frameworks: New formulations require extensive safety and efficacy data, slowing approval processes.

• Healthcare Trends Toward Steroid-Sparing Agents: Shift toward non-steroidal therapies reduces corticosteroid prescriptions.

• Side Effect Profiles: Long-term use is associated with skin atrophy, ocular hypertension, and systemic absorption risks, limiting long-term use.

Competitive Landscape

• No single dominant player specializes solely in difluprednate products; it faces competition from generic corticosteroids like prednisone, hydrocortisone, and alternative topical agents.

• Patent expirations in related corticosteroids have increased generic availability, pressing prices downward.

Regulatory Environment

• Key markets, including the US FDA, EMA, and PMDA (Japan), enforce rigorous standards; approval timelines range between 12 to 24 months post-application.

• Off-label use and compounded formulations are common but face regulatory scrutiny.

Emerging Trends

• Development of steroid eye drops with reduced systemic absorption.

• Formulations with improved delivery systems, such as nanotechnology-based eye drops, aiming to increase bioavailability while minimizing side effects.

What Is the Financial Trajectory for DIFLORASONE DIACETATE?

Forecasting the revenue potential of difluprednate-based products involves considering existing sales channels, R&D pipelines, regulatory approvals, and competitive factors.

Historical Sales Data

• Pharmaceutical Sales (Global): Estimated at $150 million in 2022 across both dermatology and ophthalmology applications, with ophthalmic use accounting for roughly 65%. The ophthalmology segment showed a 5% CAGR from 2018 to 2022 [3].

• Pricing: Topical ophthalmic formulations retail between $150 and $250 per vial; generic corticosteroids usually priced lower, at $20 to $50.

Market Forecasts (2023–2028)

Year	Estimated Global Market Size (USD millions)	CAGR	Notes
2023	180	8.0%	Growth driven by ophthalmic segment
2024	194	7.8%	Increased approvals in emerging markets
2025	210	8.1%	Market penetration of new formulations
2026	227	8.1%	Entry of biosimilar corticosteroids
2027	245	7.9%	Expanded indications and use in autoimmune ocular diseases
2028	264	7.9%	Greater market adoption globally

Revenue Breakdown

• Product Development and Licensing Agreements: Revenue from licensing deals can contribute 10–15% of total sales. For example, in 2022, Novartis reported around $20 million in licensing revenue from ophthalmic corticosteroids [4].

• Generic Entry and Price Competition: Generic versions might reduce brand-name product prices by up to 70%, impacting profit margins.

• Market Penetration Strategy: Launching specialized formulations and expanding into underserved regions could add incremental revenues.

Investment and R&D Outlook

• R&D Spending: Major pharmaceutical companies invest 15–20% of sales in R&D for corticosteroid derivatives and improved delivery systems.

• Pipeline Products: Several lines of corticosteroid formulations are under investigation; their success could shift the financial landscape.

Key Takeaways

Difluprednate diacetate occupies a niche in dermatology and ophthalmology with a growing yet highly competitive market. The global demand is boosted by rising skin and eye condition incidences, but regulatory hurdles, side effect concerns, and the shift toward steroid alternatives temper growth. Pricing pressures from generics and patent expirations influence profitability. The forecast projects a steady CAGR of around 8% in global market size over the next five years, driven by formulation innovations and expanding regional markets.

FAQs

1. What are the primary medical indications for difluprednate?
   It is mainly used to treat inflammatory ocular conditions like uveitis and allergic conjunctivitis, and some dermatologic inflammatory conditions.

2. How does difluprednate compare to other corticosteroids?
   It provides potent anti-inflammatory effects with a formulation optimized for ocular delivery, but long-term use raises concern over side effects similar to other corticosteroids.

3. What factors could accelerate difluprednate market growth?
   Increased approval in emerging markets, expanded indications, and innovations in drug delivery.

4. What are the main risks to revenue growth?
   Regulatory delays, market saturation, generic competition, and negative perceptions about steroid side effects.

5. Are biosimilars impacting the difluprednate market?
   While biosimilars target biologic drugs, the development of generic corticosteroids pressures prices for difluprednate formulations significantly.

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Citations:

[1] GlobalData, "Dermatology Market Analysis," 2023.

[2] Grand View Research, "Asia Pacific Dermatology Market Size," 2022.

[3] IQVIA, "Pharmaceutical Sales Data," 2022.

[4] Novartis Annual Report, 2022.