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Last Updated: December 22, 2024

CALCIPOTRIENE Drug Patent Profile


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When do Calcipotriene patents expire, and what generic alternatives are available?

Calcipotriene is a drug marketed by Chartwell Rx, Glenmark Speclt, Glenmark Pharms Inc, Cosette, Fougera Pharms, Hikma, Glenmark Pharms Ltd, Padagis Israel, and Taro. and is included in fourteen NDAs.

The generic ingredient in CALCIPOTRIENE is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.

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Summary for CALCIPOTRIENE
Drug patent expirations by year for CALCIPOTRIENE
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Recent Clinical Trials for CALCIPOTRIENE

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SponsorPhase
National Cancer Institute (NCI)Phase 2
Boston UniversityPhase 2/Phase 3
University of Alabama at BirminghamPhase 4

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Pharmacology for CALCIPOTRIENE
Drug ClassVitamin 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
Chartwell Rx CALCIPOTRIENE calcipotriene CREAM;TOPICAL 200935-001 May 30, 2012 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fougera Pharms CALCIPOTRIENE calcipotriene SOLUTION;TOPICAL 078305-001 May 6, 2008 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx CALCIPOTRIENE calcipotriene SOLUTION;TOPICAL 077029-001 Nov 20, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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].

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