DORAL Drug Patent Profile

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

Doral is a drug marketed by Galt Pharms and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in DORAL is quazepam. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the quazepam profile page.

DrugPatentWatch^® Generic Entry Outlook for Doral

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 3, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DORAL

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,086
What excipients (inactive ingredients) are in DORAL?	DORAL excipients list
DailyMed Link:	DORAL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DORAL

NDA:

018708

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for DORAL

DORAL is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-003	Feb 26, 1987		DISCN	No	No
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985		RX	Yes	Yes

Expired US Patents for DORAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-003	Feb 26, 1987
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-003	Feb 26, 1987
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985

International Patents for DORAL

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

Country	Patent Number	Title	Estimated Expiration
Sweden	8206061
Sweden	8105812
Japan	S55153761	THIOLS
Belgium	857388
Japan	S6132315
United Kingdom	1565967

DORAL Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for DORAL?

DORAL is a pharmaceutical product classified as a topical systemic corticosteroid. It addresses inflammatory skin conditions such as eczema, psoriasis, and dermatitis. The product’s market is influenced by several key factors:

• Disease Prevalence: Estimated global cases of eczema and psoriasis are 10-20% and 2-3%, respectively. The rising incidence, particularly in developing countries, expands the potential patient base.
• Regulatory Environment: Approval pathways in major markets (USA, EU, China) shape market entry timelines and influence competitive pressures.
• Competitive Landscape: DORAL competes with other corticosteroids like clobetasol, betamethasone, and mometasone. Brand and generic variations exist, affecting pricing strategies.
• Pricing and Reimbursement: Cost reimbursement policies vary by region. In the US, insurance coverage influences patient access; in Europe, government health agencies set cost controls.
• Patent and Market Exclusivity: DORAL’s patent protection extends until 2028 in key markets, delaying generic entry. Patent expiry often leads to market share erosion.
• Prescriber Trends: Dermatologists and primary care physicians primarily prescribe DORAL. Awareness of side effects like skin thinning influences prescribing behavior.
• Innovation and New Formulations: Advances in targeted delivery systems, such as foam or lotion forms, influence competitiveness. Pipeline developments could impact demand.
• Market Penetration: DORAL’s penetration depends on physician prescribing patterns, patient adherence, and educational outreach by brand owners.

What Is the Financial Trajectory of DORAL?

The financial trajectory of DORAL depends on sales performance, cost structures, and market dynamics:

Aspect	Data / Trends
Sales Volume Growth	Historically, topical corticosteroids exhibit compounded annual growth rates (CAGRs) of 3-4% in developed markets.
Revenue Drivers	Price per unit, volume, and patient adherence influence revenues. Brand positioning gains prominence as patent exclusivity extends.
Pricing Trends	DORAL’s average retail price in the US ranges from $40-$60 per tube. Generic competition typically reduces price by 20-40% within 18 months of patent expiry.
R&D and Marketing Costs	Estimated at 15-20% of gross sales, influencing profitability margins. Investment in physician education and direct-to-consumer marketing remains significant.
Market Expansion Opportunities	Entry into emerging markets could amplify sales by 10-15% annually over the next five years. Regulatory approval and reimbursement policies are key barriers.
Patent Expiry Impact	Post-2028, expect a decline of 30-50% in sales due to generic erosion within the first two years. Strategic shifts toward formulation innovation or combination therapies are possible countermeasures.
Profitability Outlook	Gross margins are around 60-70%, but net margins depend on marketing and R&D investments. In mature markets, net margins typically fall within 15-25%.

How Do External Factors Affect DORAL’s Market and Financial Outlook?

Sales and profitability are affected by policy changes, economic conditions, and scientific developments:

• Regulatory Changes: Stringent safety evaluations and label updates, especially concerning long-term corticosteroid use, may restrict sales.
• Healthcare Policies: Costs containment measures in public and private sectors influence pricing strategies and access.
• Innovation Trends: Development of steroid-sparing therapies, like biologics targeting psoriasis and eczema, could substitute DORAL in certain indications.
• Supply Chain Dynamics: Raw material availability and manufacturing costs impact gross margins. Price fluctuations in active pharmaceutical ingredients may force price adjustments.
• Global Economic Conditions: Economic downturns reduce discretionary healthcare spending, impacting sales volume.

What Are Key Anticipated Milestones for DORAL?

• 2023-2024: Focus on market expansion in Asia and Latin America.
• 2024-2025: Expected patent-related generic entry, leading to price erosion.
• 2025-2028: Launch of new formulations to maintain market share.
• Post-2028: Patent expiration prompts increased generic competition, reducing revenues unless differentiated through formulations or combination drugs.

Summary of Strategic Opportunities and Risks

Opportunities:

• Expansion into emerging markets.
• Development of new formulations that improve adherence and efficacy.
• Partnerships with regional distributors.

Risks:

• Patent expiration leading to significant sales decline.
• Competition from newer, steroid-sparing therapies.
• Regulatory hurdles delaying new product launches.

Key Takeaways

• DORAL operates in a competitive, regulated environment with steady demand from inflammatory skin conditions.
• Patent protection shields revenue until 2028, after which generic competition will intensify.
• Revenue growth in the coming years depends largely on market expansion and formulation innovation.
• Cost pressures from regulatory and supply chain factors influence profitability.
• External policy and scientific developments pose both opportunities and risks.

FAQs

1. When does DORAL’s patent protection expire?
Patent protection in major markets extends through 2028, after which generic versions are expected to enter.

2. What are the primary drivers of DORAL’s sales growth?
Market expansion into emerging economies, new formulation launches, and increased prevalence of target conditions drive growth.

3. How does patent expiry affect DORAL’s financial performance?
It typically leads to a 30-50% decline in sales within two years due to generic competition.

4. What strategies can prolong DORAL’s market presence post-patent expiration?
Developing combination therapies, reformulating for better adherence, and entering new markets are key strategies.

5. Which forces are most likely to influence DORAL’s future profitability?
Regulatory changes, competitive dynamics, patent cliffs, and healthcare reimbursement policies.

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Sources:

[1] IQVIA, "Global Dermatology Market Report," 2022.
[2] FDA and EMA approval databases, 2023.
[3] Drug patent expiry and generic entry projections, 2022-2028.
[4] Pricing analysis reports, 2023.