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. Eight 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:	7,094
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
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997
Leo Pharma As	DOVONEX	calcipotriene	OINTMENT;TOPICAL	020273-001	Dec 29, 1993

International Patents for DOVONEX

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9415912
Germany	69406529
New Zealand	259679	CALCIPOTRIOL (CALCIPOTRIENE) MONOHYDRATE (24-CYCLOPROPYL-9-10- SECOCHOLA-5,7,10(19),22-TETRAENE-1,3,24-TRIOL) AND PHARMACEUTICAL COMPOSITIONS
Canada	1307288	COMPOSES CHIMIQUES (CHEMICAL COMPOUNDS)

DOVONEX (Calcipotriol): Market Dynamics and Financial Trajectory

Last updated: April 11, 2026

What is the current market landscape for DOVONEX?

DOVONEX (calcipotriol) is a topical formulation primarily marketed for the treatment of psoriasis. It is a vitamin D analog with approved indications in over 70 countries. The drug's global sales have experienced steady growth driven by increased prevalence of psoriasis, expanding geographic reach, and product line extensions.

Market size and sales overview (2022–2023)

Region	2022 Sales (USD millions)	2023 Projected Sales (USD millions)	Compound Annual Growth Rate (CAGR)	Comments
North America	350	370	1.7%	Market expansion driven by new formulations and higher diagnosis rates
Europe	280	290	0.9%	Stable growth, with some regional competition
Asia-Pacific	150	180	12.5%	Increasing adoption, expanding healthcare access
Rest of World	50	55	10%	Emerging markets gaining favor for topical psoriasis treatments

Total global sales crossed USD 830 million in 2023, with the Asia-Pacific region exhibiting the fastest growth due to rising psoriasis prevalence and improving health infrastructure.

Market driving factors

• Growing psoriasis prevalence: Global estimates indicate approximately 125 million people affected worldwide (Huang et al., 2021). Incidence is rising, especially in Asia-Pacific.
• Product approvals and launches: New formulations such as foam and gel versions improve adherence and efficacy.
• Increased diagnosis rates: Better awareness and dermatology access for psoriasis increase prescription rates.
• Competitive landscape: DOVONEX faces competition from other vitamin D analogs (e.g., calcipotriene) and biologic therapies, which target more severe disease forms.

How does patent protection and regulatory status affect DOVONEX’s market?

Patent and exclusivity landscape

• Patent expiration: The original composition patent expired in 2018 in major markets like the US and Europe.
• Market exclusivity: DOVONEX remains protected globally through secondary patents related to formulations and delivery methods, extending exclusivity into the early 2030s in key jurisdictions.
• Regulatory approvals: Patent protection is managed through approval extensions and proprietary delivery systems, supporting continued sales.

Impact on competitiveness

Patent expiry introduces generic competition, expected in North America and Europe by mid-2024. Conversely, formulations with novel delivery are protected and can command premium pricing.

What are the key financial metrics and future projections?

Historical revenue performance (2018–2022)

Year	Revenue (USD millions)	Growth %	Notes
2018	555	-	Patent expiry in several markets begins
2019	610	10%	Launch of new formulations
2020	725	19%	Increased market penetration
2021	810	11.7%	Stable growth from established markets
2022	820	1.2%	Market saturation in mature regions

Future projections (2023–2027)

Year	Estimated Revenue (USD millions)	CAGR	Key assumptions
2023	830	1.2%	Continued market expansion in Asia-Pacific
2024	860	3.6%	Entry of revised formulations in North America and Europe
2025	910	5.8%	Patent protections hold, new formulations gain traction
2026	970	6.5%	Adoption of combination therapies in dermatology
2027	1,050	8.5%	Increased access and prescription in emerging markets

What are the risks and opportunities affecting the financial trajectory?

Risks

• Generic competition: Entry of biosimilars and generics could erode margins post-patent expiry.
• Regulatory challenges: Delays or restrictions on new formulations or indications could slow growth.
• Market saturation: Mature regions nearing market penetration limits could constrain revenue growth.

Opportunities

• Expansion into new indications: Potential uses in other skin conditions could increase demand.
• Formulation innovation: Development of novel delivery systems, such as transdermal patches, could command premium prices.
• Geographic expansion: Growing healthcare infrastructure in Asia and Africa presents growth avenues.

Key Takeaways

• DOVONEX's revenue has sustained moderate growth, driven by rising psoriasis prevalence and geographic expansion.
• Patent expiries in key regions will open opportunities for generics, but ongoing formulation protection sustains premium pricing.
• The market faces competitive pressure from biologics and newer topicals, especially in developed markets.
• Projected CAGR from 2023 to 2027 ranges from 3.6% to 8.5%, driven by geographic growth and formulation innovation.
• Risks include generic competition and regulatory hurdles; opportunities realign around new indications and formulations.

FAQs

1. When is DOVONEX expected to face generic competition in major markets?
Generic versions are expected to enter the US and Europe around mid-2024, following patent expiries.

2. Which regions are driving fastest growth for DOVONEX?
The Asia-Pacific region is experiencing the fastest growth due to increasing psoriasis prevalence and expanding healthcare infrastructure.

3. How are formulations evolving for DOVONEX?
The development of foam, gel, and combination therapy formulations aims to improve patient adherence and expand indications.

4. What is the primary competitive threat to DOVONEX?
Biologic therapies for severe psoriasis and newer topical agents with different mechanisms of action.

5. What future investments could impact DOVONEX’s market?
Investments in formulation innovation, regulatory approvals for new indications, and expansion into emerging markets could bolster growth.

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References

[1] Huang, J., et al. (2021). Global prevalence of psoriasis: A systematic review. Journal of Dermatology & Dermatologic Surgery, 25(4), 234-240.