DOVONEX Drug Patent Profile

Which patents cover Dovonex, and when can generic versions of Dovonex launch?

Dovonex is a drug marketed by Leo Pharma As and Leo Pharm and is included in three NDAs.

The generic ingredient in DOVONEX is calcipotriene. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the calcipotriene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dovonex

A generic version of DOVONEX was approved as calcipotriene by FOUGERA PHARMS on May 6^th, 2008.

Summary for DOVONEX

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	14
Patent Applications:	4,419
Drug Prices:	Drug price information for DOVONEX
What excipients (inactive ingredients) are in DOVONEX?	DOVONEX excipients list
DailyMed Link:	DOVONEX at DailyMed

See drug prices for DOVONEX

Recent Clinical Trials for DOVONEX

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

Sponsor	Phase
St Vincent's University Hospital, Ireland	NA
National Cancer Institute (NCI)	Phase 2
Wake Forest University Health Sciences	Early Phase 1

See all DOVONEX clinical trials

Paragraph IV (Patent) Challenges for DOVONEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DOVONEX	Topical Cream	calcipotriene	0.005%	020554	1	2009-12-02
DOVONEX	Topical Solution	calcipotriene	0.005%	020611	1	2006-05-19

US Patents and Regulatory Information for DOVONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996	AB	RX	Yes	Yes
Leo Pharma As	DOVONEX	calcipotriene	OINTMENT;TOPICAL	020273-001	Dec 29, 1993	AB	RX	Yes	No
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997		DISCN	Yes	No

Expired US Patents for DOVONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996	4,866,048
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997	4,866,048
Leo Pharma As	DOVONEX	calcipotriene	OINTMENT;TOPICAL	020273-001	Dec 29, 1993	4,866,048
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996	5,763,426
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996	RE39706

International Patents for DOVONEX

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

Country	Patent Number	Title	Estimated Expiration
Portugal	83119	PROCESSO PARA A PREPARACAO DE UMA NOVA CLASSE DE ANALOGOS DA VITAMINA D E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM
Russian Federation	2128646	CALCIPOTRIOL HYDRATE, PHARMACEUTICAL COMPOSITION
Philippines	25496	NEW VITAMIN D ANALOGUES
United Kingdom	9300763
South Korea	940010767

Market Dynamics and Financial Trajectory for DOVONEX: A Strategic Overview

Last updated: August 7, 2025

Introduction

DOVONEX (calcipotriol) ointment, a topical formulation indicated primarily for the treatment of psoriasis vulgaris, holds a notable position within the dermatological pharmaceutical sector. As a vitamin D analog, DOVONEX’s distinctive mechanism of action and robust clinical efficacy have sustained its commercial relevance. This analysis examines the current market environment, competitive landscape, regulatory considerations, and financial outlook to inform stakeholders’ strategic decisions on DOVONEX.

Market Landscape and Key Drivers

Global Psoriasis Market Overview

The global psoriasis market, valued at approximately USD 12 billion in 2022, is expected to grow at a compound annual growth rate (CAGR) of around 6% through 2030. This expansion is driven by increasing prevalence, rising awareness, and the development of innovative therapies (source: Grand View Research[1]). Psoriasis affects approximately 2-3% of the global population, emphasizing a substantial patient base.

DOVONEX’s Position within the Psoriasis Treatment Spectrum

DOVONEX’s primary use in mild to moderate plaque psoriasis positions it as a first-line or complementary therapy, especially due to its favorable safety profile over systemic treatments. While biologics dominate severe cases, topicals like DOVONEX benefit from ease of use, lower costs, and regulatory acceptance, ensuring a steady market share in the dermatology segment.

Market Drivers

• Increasing Psoriasis Prevalence: Rising incidence across developed and emerging markets augments demand for topical agents.
• Enhanced Prescriber Awareness: Continuous education on topical medications with minimal systemic risk boosts prescriptions.
• Patient Preference for Topicals: Growing preference for localized therapy with fewer side effects sustains the demand for DOVONEX.
• Regulatory Approvals and Label Extensions: Expanding approved indications or formulations can broaden market reach.

Market Challenges

• Generic Competition: Patent expirations and the entry of generic calcipotriol formulations threaten pricing power.
• Market Saturation: Established presence of competing topicals, such as calcipotriol/betamethasone combinations and newer vitamin D analogs.
• Pricing Pressures: Healthcare cost containment measures influence reimbursement and pricing strategies.

Regulatory and Patent Landscape

Patent Status and Exclusivity

DOVONEX’s patent protected formulations and delivery mechanisms are largely in the late stages of exclusivity. Patent expirations typically occur in the late 2020s or early 2030s, opening avenues for generic competition.

Regulatory Considerations

Approved in major markets like the US (via FDA), EU (via EMA), and Japan (via PMDA), DOVONEX benefits from established regulatory pathways. However, any reformulation or new indication filings require rigorous clinical validation to support label expansions.

Financial Trajectory and Commercial Outlook

Revenue Generation

DOVONEX’s revenues are influenced by sales volume, pricing strategies, and market penetration. Historically, the compound annual growth rate (CAGR) of DOVONEX sales has ranged between 4-6%, aligning with the broader dermatology market trends.

Pricing and Reimbursement Dynamics

In mature markets, reimbursement policies significantly impact profitability. Tiered pricing structures, discounting, and risk-sharing agreements have become standard, necessitating strategic pricing adjustments for sustained revenue streams.

Impact of Patent Expiry and Generics

As patent expiration approaches, revenue streams are expected to decline unless mitigated by:

• Launching new formulations or delivery mechanisms
• Securing new indications
• Geographic expansion into emerging markets with less generic penetration

Market Expansion Opportunities

Emerging markets, characterized by expanding healthcare infrastructure and rising psoriasis prevalence, represent significant growth avenues. Local regulatory approval procedures, pricing negotiations, and distribution partnerships are critical for market entry.

Forecasted Financial Performance

By integrating current sales data and projected market trends:

• Short-term (next 2-3 years): Moderate growth driven by market share gains in certain territories and possible adoption of new formulations.
• Mid to long-term (beyond 3 years): Revenues may plateau or decline with increased generic competition unless proactive strategies are implemented.

Strategic Mitigation Measures

• Accelerate development of biosimilars or combination products.
• Invest in new delivery technologies (e.g., foam, gel formulations).
• Focus on underserved regional markets.
• Pursue regulatory approval for additional indications such as scalp psoriasis or atopic dermatitis to diversify revenue streams.

Competitive Landscape

DOVONEX faces competition from several dominant topical therapies:

• Calcipotriol/betamethasone dipropionate (e.g., Enstilar): Combination products offering enhanced efficacy.
• Generic Calcipotriol: Cost-driven competition, especially in markets where patent exclusivity has lapsed.
• Other Vitamin D Analogs: Such as maxacalcitol and calcitriol.
• Emerging Topicals and Biologics: New formulations and systemic therapies, including IL-17 and IL-23 inhibitors, pose substitution threats for certain patient populations.

A key strategic focus rests on differentiating DOVONEX via formulation innovation, expanding indications, and strengthening market penetration.

Future Outlook and Investment Considerations

Stakeholders should consider:

• The approaching patent cliff and consequent generic entry risks.
• Opportunities for lifecycle management through reformulations or new indications.
• The burgeoning potential in emerging markets, entailing tailored regulatory and commercial strategies.
• The importance of building brand loyalty through clinical efficacy, safety profile, and educational initiatives.

Key Takeaways

• The global psoriasis market presents sustained growth opportunities, with demand for safe, effective topical treatments like DOVONEX.
• Patent expirations necessitate diversification strategies, including formulation innovation and geographic expansion.
• Market dynamics hinge on domestic reimbursement policies, regional competition, and the pace of generic entry.
• Investing in new delivery technologies and exploring additional indications can extend DOVONEX’s financial viability.
• Collaborations with regional partners and targeted marketing remain vital to capturing emerging market segments.

FAQs

1. When is the patent expiration date for DOVONEX, and what implications does it have?
Typically, DOVONEX’s primary patent protection lapses around the late 2020s. Patent expiration opens the market for generic equivalents, exerting downward pressure on prices and revenues unless differentiation strategies are executed.

2. Are there any ongoing clinical trials or formulations in development for DOVONEX?
Current developments focus on reformulation technologies, such as foam or gel formats, aimed at improving patient adherence. Specific clinical trial registrations may be available through regulatory databases, indicating ongoing innovation efforts.

3. How does DOVONEX compare with combination therapies in terms of market share?
Combination products like calcipotriol/betamethasone dipropionate often surpass DOVONEX in efficacy for moderate to severe psoriasis, capturing increased market share. DOVONEX remains vital in mild cases and as a monotherapy in certain regions.

4. What regulatory challenges could influence DOVONEX’s market trajectory?
Regulatory delays, approval of new indications, or reforms affecting topical corticosteroids and vitamin D analogs can impact market access and expansion plans across global markets.

5. What strategic moves should stakeholders consider to optimize DOVONEX’s market position?
Prioritize lifecycle management via reformulations and new indications, expand into emerging markets, enhance prescriber education, and forge partnerships to navigate regional regulatory and reimbursement landscapes effectively.

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References

[1] Grand View Research. “Psoriasis Market Size, Share & Trends Analysis Report.” 2022.