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:	51
Clinical Trials:	13
Patent Applications:	5,462
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
National Cancer Institute (NCI)	Phase 2
Wake Forest University Health Sciences	Early Phase 1
Guangdong Provincial Hospital of Traditional Chinese Medicine	N/A

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 Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997	4,866,048
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	RE39706
Leo Pharm	DOVONEX	calcipotriene	SOLUTION;TOPICAL	020611-001	Mar 3, 1997	5,763,426
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	RE39706

International Patents for DOVONEX

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

Country	Patent Number	Title	Estimated Expiration
Ireland	861894
Ireland	58545	Novel vitamin d analogues
Germany	3666587
Hong Kong	63492	NOVEL VITAMIN D ANALOGUES
Japan	H08505612
Australia	663249

DOVONEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dovonex

Introduction to Dovonex

Dovonex, also known as Calcipotriene, is a topical medication used primarily for the treatment of psoriasis. It belongs to the class of vitamin D analogues and works by slowing down the growth of skin cells, which is a key factor in the development of psoriasis symptoms.

Market Overview

The global psoriasis treatment market, within which Dovonex operates, is experiencing significant growth driven by several factors.

Increasing Prevalence of Psoriasis

The rising prevalence of psoriasis worldwide is a major driver for the market. Psoriasis is one of the leading skin conditions, and its increasing incidence is fueling the demand for effective treatments like Dovonex[3].

Geographical Market Performance

North America is anticipated to dominate the global dermatological drugs market, including psoriasis treatments, during the forecast period from 2024 to 2030. This dominance is attributed to the growing demand for dermatological drugs, heightened awareness of skin health, and the presence of major market players in the region[3].

Market Dynamics

Competitive Landscape

The dermatological drugs market, including the segment for psoriasis treatments, is highly competitive. Key players such as Amgen Inc, Bausch Health Companies Inc, Novartis AG, AbbVie Inc, and others are actively involved in developing and marketing psoriasis treatments. Dovonex, being a well-established product, faces competition from both branded and generic alternatives[3].

Regulatory Environment

The regulatory landscape plays a crucial role in shaping the market for Dovonex. FDA approvals and regulatory evaluations are critical for the introduction and continued use of dermatological drugs. For instance, the FDA's approval of innovative treatments, including novel topical formulations and systemic therapies, creates new opportunities for market growth. However, regulatory hurdles and market exclusivity periods can also pose challenges[3].

Pipeline Analysis

The pipeline for psoriasis treatments is robust, with several Phase 1, 2, and 3 drugs in development. For example, the promising Phase 3b results from the VISIBLE trial evaluating the effectiveness of TREMFYA (guselkumab) in patients with moderate to severe plaque psoriasis and scalp psoriasis indicate potential future competition and opportunities for market expansion[3].

Financial Trajectory

Market Size and Growth

The global psoriasis treatment market is expected to grow significantly, with the dermatological drugs market projected to cross USD 31 billion by 2030. The psoriasis category had a significant revenue share in 2023, indicating a strong financial trajectory for treatments like Dovonex[3].

Revenue Forecast

The market size for psoriasis treatments is forecasted to increase, driven by factors such as the increasing prevalence of skin conditions, growing spending on skincare and personal care, and a rising population of elderly individuals susceptible to skin disorders. The CAGR for the dermatological drugs market is estimated to be around 11% from 2021 to 2030[3].

Regional Performance

North America, being the dominant region, will continue to drive the market growth for psoriasis treatments. The region's strong healthcare infrastructure, high awareness of skin health, and the presence of major pharmaceutical companies contribute to its leading position in the market[3].

Product Performance and Efficacy

Clinical Efficacy

Dovonex has demonstrated significant clinical efficacy in treating psoriasis. Adequate and well-controlled trials have shown that patients treated with Dovonex ointment experience improvement usually beginning after two weeks of therapy. After 8 weeks of once daily or twice daily use, a substantial percentage of patients showed marked improvements, with some achieving complete clearing of symptoms[4].

Market Share and Competition

While Dovonex is a well-established product, its market share is influenced by the presence of other treatments, including biologics and systemic therapies. The rise of generic and biosimilar dermatological drugs also impacts the market dynamics, potentially affecting the pricing and accessibility of Dovonex[3].

Challenges and Opportunities

Regulatory Hurdles

High costs associated with bringing new drugs to market, along with regulatory hurdles and market exclusivity periods, can present challenges for manufacturers of Dovonex and similar treatments[3].

Generic and Biosimilar Impact

The rise of generic and biosimilar dermatological drugs is expected to lower prices and make treatments more accessible. This trend can both challenge the market share of branded products like Dovonex and create opportunities for more affordable treatment options[3].

Key Takeaways

• Market Growth: The psoriasis treatment market, driven by the increasing prevalence of skin conditions and growing awareness of skin health, is expected to see substantial growth.
• Regional Dominance: North America is anticipated to dominate the global dermatological drugs market, including psoriasis treatments.
• Competitive Landscape: The market is highly competitive with several key players and a robust pipeline of new treatments.
• Regulatory Environment: FDA approvals and regulatory evaluations are critical for market growth and pose challenges.
• Financial Trajectory: The market size for psoriasis treatments is forecasted to increase, driven by various factors.

FAQs

1. What is Dovonex used for?

   • Dovonex, or Calcipotriene, is used primarily for the treatment of psoriasis by slowing down the growth of skin cells.

2. Which region dominates the market for psoriasis treatments?

   • North America is anticipated to dominate the global dermatological drugs market, including psoriasis treatments, during the forecast period.

3. What are the key drivers for the psoriasis treatment market?

   • The market is driven by the increasing prevalence of skin conditions, growing spending on skincare and personal care, and a rising population of elderly individuals susceptible to skin disorders.

4. How effective is Dovonex in treating psoriasis?

   • Dovonex has demonstrated significant clinical efficacy, with patients showing marked improvements and some achieving complete clearing of symptoms after 8 weeks of use.

5. What challenges does Dovonex face in the market?

   • Dovonex faces challenges from regulatory hurdles, market exclusivity periods, and the rise of generic and biosimilar dermatological drugs.

Cited Sources

1. Psoriasis Treatment Market and Forecast 2024-2031 - iHealthcareAnalyst
2. US SECURITIES & EXCHANGE COMMISSION FORM 20-F 2012 - Novartis
3. Global Dermatological Drugs Market to Cross USD 31 Billion by 2030 - PR Newswire
4. Dovonex - accessdata.fda.gov - FDA
5. Delivering Shareholder Value | AstraZeneca - AstraZeneca