CALCIPOTRIENE - Generic Drug Details

What are the generic drug sources for calcipotriene and what is the scope of freedom to operate?

Calcipotriene is the generic ingredient in three branded drugs marketed by Mayne Pharma, Chartwell Rx, Glenmark Speclt, Leo Pharma As, Glenmark Pharms Inc, Cosette, Fougera Pharms, Hikma, and Leo Pharm, and is included in twelve NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Calcipotriene has twenty-nine patent family members in thirteen countries.

There are twelve drug master file entries for calcipotriene. Eight suppliers are listed for this compound.

Summary for CALCIPOTRIENE

International Patents:	29
US Patents:	2
Tradenames:	3
Applicants:	9
NDAs:	12
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	38
Patent Applications:	6,910
Drug Prices:	Drug price trends for CALCIPOTRIENE
What excipients (inactive ingredients) are in CALCIPOTRIENE?	CALCIPOTRIENE excipients list
DailyMed Link:	CALCIPOTRIENE at DailyMed

See drug prices for CALCIPOTRIENE

Recent Clinical Trials for CALCIPOTRIENE

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Boston University	Phase 2/Phase 3
University of Alabama at Birmingham	Phase 4

See all CALCIPOTRIENE clinical trials

Pharmacology for CALCIPOTRIENE

Drug Class

Vitamin D Analog

Paragraph IV (Patent) Challenges for CALCIPOTRIENE

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 CALCIPOTRIENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	077579-001	Nov 19, 2009		DISCN	No	No
Fougera Pharms	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	078305-001	May 6, 2008	AT	RX	No	No
Cosette	CALCIPOTRIENE	calcipotriene	SOLUTION;TOPICAL	078468-001	Mar 24, 2011	AT	RX	No	Yes
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563-001	Oct 6, 2010		RX	Yes	Yes	8,629,128		Y
Glenmark Speclt	CALCIPOTRIENE	calcipotriene	CREAM;TOPICAL	205772-001	Jun 9, 2015	AB	RX	No	No

Expired US Patents for CALCIPOTRIENE

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

International Patents for CALCIPOTRIENE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1112062	COMPOSITION DE MOUSSE (MOUSSE COMPOSITION)
Australia	6069299	Mousse composition
Denmark	1112062
Poland	2526930
Spain	2407407

CALCIPOTRIENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Calcipotriene

Introduction

Calcipotriene, a vitamin D analog, has been a significant player in the dermatology market since its introduction in 1994. It is primarily used to treat psoriasis but has also found applications in other dermatological conditions. This article delves into the market dynamics and financial trajectory of calcipotriene, highlighting its clinical trends, financial performance, and market impact.

Clinical Trends and Utilization

Following its introduction, calcipotriene quickly became the most prescribed medication for psoriasis in the United States, as indicated by the National Ambulatory Medical Care Survey (NAMCS) data[1].

• Psoriasis Treatment: Calcipotriene is highly effective in treating psoriasis by regulating cellular differentiation.
• Off-Label Uses: Nearly 57% of calcipotriene mentions were not linked to a diagnosis of psoriasis, indicating its utility in other dermatoses[1].

Market Performance and Sales

The market performance of calcipotriene is closely tied to its widespread adoption and the financial health of the companies that produce and distribute it.

• Sales Growth: Calcipotriene, often combined with betamethasone dipropionate (C/BD), has shown significant sales growth. For instance, Novan reported a 216% growth in sales of WYNZORA® (calcipotriene and betamethasone dipropionate) in the third quarter of 2022 compared to the same period in 2021[5].
• Revenue Contribution: The combination product C/BD foam has contributed substantially to the revenue of companies like Novan, with net product revenues reaching $4.6 million in the third quarter of 2022[5].

Financial Impact on Healthcare Systems

The introduction of calcipotriene and its combination products has had a notable financial impact on healthcare systems.

• Cost Savings: A budget impact model (BIM) showed that the introduction of C/BD foam could decrease the annual cost of treatment (COT) for moderate-to-severe psoriasis by $36,112,572 for a hypothetical US healthcare plan with 1 million members. This translates to a decrease in the COT per member per month (PMPM) by $3.00[3].
• Comparative Costs: Calcipotriene and betamethasone dipropionate foam has the lowest per-patient cost ($9,913) necessary to achieve a Psoriasis Area and Severity Index (PASI)-75 response compared to other treatments like biologics[3].

Company Performance and Pipeline

Companies involved in the production and distribution of calcipotriene have seen varied financial performances and pipeline developments.

• Almirall: Almirall, a company with a strong EU dermatology portfolio, reported solid financial results in 2021, with core net sales reaching €809.8 million and core EBITDA growing by 17% year-on-year. Their growth drivers, including dermatology products, contributed significantly to this performance[2].
• Novan: Novan, another key player, reported total revenue of $5.1 million in the third quarter of 2022, driven by the sales of their medical dermatology products, including WYNZORA®. Despite a net loss, the company showed growth in prescription activity and a strong cash position[5].

Market Dynamics and Competition

The market for calcipotriene is influenced by several dynamics, including competition from other treatments and regulatory environments.

• Competition from Biologics: While calcipotriene remains a cost-effective option, the market is competitive with biologics like etanercept, adalimumab, and secukinumab. However, the lower cost and efficacy of calcipotriene make it a preferred choice for many patients and healthcare providers[3].
• Regulatory Environment: The regulatory environment plays a crucial role in the market dynamics. Approvals and formulary inclusions significantly impact the sales and adoption of calcipotriene products[3].

Global Market Outlook

The global calcipotriene market is expected to continue growing, driven by increasing demand for effective and cost-efficient treatments for psoriasis and other dermatological conditions.

• Market Size and Growth: The global calcipotriene market is anticipated to see significant growth, driven by factors such as increasing prevalence of psoriasis, advancements in treatment options, and favorable regulatory environments[4].

Research and Development

Continuous research and development are crucial for maintaining the market position of calcipotriene.

• Pipeline Progress: Companies like Almirall are making encouraging progress on their R&D pipelines, with positive topline phase 3 results from clinical trials for new treatments, such as lebrikizumab for atopic dermatitis[2].
• Innovation: Innovations in formulations, such as the combination of calcipotriene with other active ingredients like betamethasone dipropionate, continue to enhance the efficacy and appeal of calcipotriene products[3].

Financial Health and Cash Flow

The financial health of companies producing calcipotriene is a key indicator of the drug's market trajectory.

• Cash Flow: Novan reported a total cash and cash equivalents balance of $14.9 million as of September 30, 2022, indicating a manageable financial position despite operational losses[5].
• Operating Expenses: Companies like Novan have seen increases in selling, general, and administrative expenses, but these are often offset by strong revenue growth from their product portfolios[5].

Conclusion

Calcipotriene has established itself as a cornerstone in the treatment of psoriasis and other dermatological conditions. Its market dynamics are characterized by strong sales growth, significant cost savings for healthcare systems, and a competitive landscape that includes biologics. The financial performance of companies involved in its production and distribution highlights the drug's importance and the ongoing efforts to innovate and expand its applications.

Key Takeaways

• Calcipotriene is a highly prescribed medication for psoriasis and has off-label uses in other dermatoses.
• The drug offers significant cost savings compared to biologic treatments.
• Companies like Novan and Almirall have seen strong revenue growth from calcipotriene products.
• Continuous R&D and innovation are crucial for maintaining market position.
• The global calcipotriene market is expected to grow driven by increasing demand and favorable regulatory environments.

FAQs

Q: What is calcipotriene primarily used for? A: Calcipotriene is primarily used to treat psoriasis, but it also has applications in other dermatological conditions.

Q: How does calcipotriene compare to biologic treatments in terms of cost? A: Calcipotriene is significantly more cost-effective than biologic treatments, with a lower per-patient cost necessary to achieve a Psoriasis Area and Severity Index (PASI)-75 response[3].

Q: Which companies are key players in the calcipotriene market? A: Companies like Novan and Almirall are key players in the calcipotriene market, with significant contributions from their dermatology product portfolios[2][5].

Q: What is the expected growth trajectory for the global calcipotriene market? A: The global calcipotriene market is expected to see significant growth driven by increasing demand for effective and cost-efficient treatments for psoriasis and other dermatological conditions[4].

Q: How has the introduction of calcipotriene impacted healthcare costs? A: The introduction of calcipotriene and its combination products has led to significant cost savings for healthcare systems, with an estimated annual cost of treatment reduction of $36,112,572 for a hypothetical US healthcare plan with 1 million members[3].