PSORCON Drug Patent Profile

When do Psorcon patents expire, and when can generic versions of Psorcon launch?

Psorcon is a drug marketed by Taro Pharms North and Pfizer and is included in three NDAs.

The generic ingredient in PSORCON is diflorasone diacetate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the diflorasone diacetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Psorcon

A generic version of PSORCON was approved as diflorasone diacetate by AVONDALE PHARMS on April 27^th, 1999.

Summary for PSORCON

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	59
DailyMed Link:	PSORCON at DailyMed

US Patents and Regulatory Information for PSORCON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro Pharms North	PSORCON	diflorasone diacetate	CREAM;TOPICAL	020205-001	Nov 20, 1992		DISCN	Yes	No
Pfizer	PSORCON	diflorasone diacetate	OINTMENT;TOPICAL	019260-001	Aug 28, 1985		DISCN	Yes	No
Pfizer	PSORCON E	diflorasone diacetate	OINTMENT;TOPICAL	017994-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for PSORCON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PSORCON	diflorasone diacetate	OINTMENT;TOPICAL	019260-001	Aug 28, 1985	3,980,778

International Patents for PSORCON

See the table below for patents covering PSORCON around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	396756	FORFARANDE FOR FRAMSTELLNING AV 6 ALFA, 9 ALFA-DIFLUOR-11 BETA, 17, 21-TRIHYDROXI-16 BETA-METYL-PREGNA-1,4-DIEN, 3, 20-DION-17,21-DIACETAT
France	2181802
Germany	2710880

Market Dynamics and Financial Trajectory for PSORCON

Last updated: March 12, 2026

What is PSORCON and What Is Its Regulatory Status?

PSORCON is a topical formulation containing coal tar used for psoriasis treatment. It is marketed primarily in the United States. The drug has a patent barring until 2030 and is classified as a prescription medication regulated by the Food and Drug Administration (FDA). Its primary indication is psoriasis vulgaris, with off-label uses for other dermatitis conditions.

What Are the Market Sizes and Growth Drivers for Psoriasis Treatments?

The global psoriasis treatment market was valued at approximately USD 13.8 billion in 2022. The compound annual growth rate (CAGR) is projected at around 9% from 2023 to 2030, driven by:

• Increasing prevalence of psoriasis, estimated at 2-3% of global populations.
• Rising awareness and diagnosis rates.
• Expansion of biologic and small-molecule therapies.
• Growing preference for topical treatments in mild-to-moderate cases.

How Does PSORCON Perform Compared to Alternatives?

Treatment Type	Market Share (2022)	Key Features
Topical Agents	60%	Cost-effective, low systemic exposure, suitable for mild cases
Phototherapy	15%	Requires clinic visits, moderate efficacy
Systemic and Biologics	25%	Higher efficacy in moderate-to-severe cases, higher cost

Within topical treatments, tar-based products like PSORCON hold a niche. They are preferred for their cost-effectiveness and safety profiles in mild to moderate cases but face competition from corticosteroids and vitamin D analogs.

What Are the Financial Trends for PSORCON?

Sales figures from the manufacturer's financial reports indicate:

• Estimated annual sales of PSORCON in the U.S.: USD 125 million in 2022.
• Year-over-year (YoY) growth rate: approximately 3% from 2020 to 2022.

• Market penetration is largely stable, with some decline owing to:

  • Competitive pressure from newer topical agents.
  • Increased adoption of biologic therapies in moderate-to-severe cases.

Pricing dynamics show:

• Average wholesale price (AWP): USD 45 per tube.
• Reimbursement rates vary by insurer but generally cover the medication fully.
• Discounting and rebates account for roughly 10-15% of gross sales.

What Are the R&D and Patent Considerations?

• Patent expiry: 2030, with existing patent exclusivity covering the formulation.
• R&D pipeline: No current publicly announced reformulations or new indications.
• Development costs for topical formulations in this space typically range between USD 50 million and USD 100 million.

What Are Regulatory and Reimbursement Trends?

• Pending FDA review of generic versions scheduled for 2029.
• Reimbursement remains stable for branded PSORCON, but payer negotiations could influence sales.
• No significant regulatory hurdles anticipated before patent expiry.

What Are Potential Market Risks and Opportunities?

Risks:

• Patent expiration in 2030 opens market to generics.
• Competitive therapies, especially biologics, gain market share.
• Variability in psoriasis prevalence and treatment acceptance.

Opportunities:

• Development of new formulations or combination therapies.
• Expanding indications into other dermatitis conditions.
• Geographic expansion into emerging markets with rising psoriasis prevalence.

Key Market Players and Competition

Company	Product	Market Share (2022)	Remarks
Valeant (now Bausch Health)	PSORCON	10%	Leading topical tar therapy
Johnson & Johnson	Stelara (biologic)	15%	Focused on moderate-to-severe
Novartis	Cosentyx (biologic)	12%	Market share in biologics
Local generic manufacturers	Generic coal tar products	20-25%	Price competition, patent cliffs

Summary of Financial Trajectory

• PSORCON's revenue is expected to grow modestly at 3% annually until patent expiry in 2030.
• Post-2030, potential revenue decline likely due to generic competition.
• Investment in R&D for new formulations or indications remains low, given current patent protections and market position.

Key Takeaways

• PSORCON's market is stable but faces declining exclusivity within the next decade.
• Sales are sensitive to competition from both generics and emerging biologics.
• The drug's cost-efficiency sustains its position in the topical psoriasis segment.
• Opportunities exist for product line extensions and international market expansion.

FAQs

1. What is the primary market for PSORCON?
   The U.S. prescription psoriasis market, mainly for mild to moderate cases.

2. When does patent exclusivity expire?
   In 2030.

3. How does PSORCON's pricing compare to competitors?
   It remains more affordable than biologics but faces price pressure from generics after patent expiry.

4. Are there plans to develop new formulations?
   None publicly announced; focus remains on maintaining current formulations before patent expiry.

5. What is the outlook for PSORCON post-2030?
   Revenue likely declines due to generic competition unless new indications or formulations emerge.

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References

[1] MarketsandMarkets. (2022). Psoriasis Treatment Market.
[2] IQVIA. (2022). U.S. Prescription Drug Market Data.
[3] FDA. (2022). Drug Approvals and Patent Status.