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Last Updated: April 21, 2025

Pimecrolimus - Generic Drug Details


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

Pimecrolimus is the generic ingredient in two branded drugs marketed by Bausch, Actavis Labs Ut Inc, and Glenmark Pharms Ltd, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for pimecrolimus. Five suppliers are listed for this compound.

Summary for pimecrolimus
Drug Prices for pimecrolimus

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Recent Clinical Trials for pimecrolimus

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

SponsorPhase
National Hepatology & Tropical Medicine Research InstitutePhase 4
Combined Military Hospital AbbottabadPhase 1
Postgraduate Institute of Dental Sciences RohtakPhase 4

See all pimecrolimus clinical trials

Pharmacology for pimecrolimus

US Patents and Regulatory Information for pimecrolimus

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bausch ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Actavis Labs Ut Inc PIMECROLIMUS pimecrolimus CREAM;TOPICAL 209345-001 Dec 27, 2018 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Glenmark Pharms Ltd PIMECROLIMUS pimecrolimus CREAM;TOPICAL 211769-001 Aug 29, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Expired US Patents for pimecrolimus

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Bausch ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001 6,423,722*PED ⤷  Try for Free
Bausch ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001 5,912,238*PED ⤷  Try for Free
Bausch ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001 6,352,998*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Pimecrolimus

Introduction to Pimecrolimus

Pimecrolimus is an anti-inflammatory compound used primarily in the treatment of atopic dermatitis (AD), also known as eczema. It is a topical immunomodulator that blocks the proliferation of T-cells and inhibits the production and release of inflammatory mediators from mast cells[5].

Market Growth and Projections

The global pimecrolimus market has experienced significant growth in recent years and is projected to continue this upward trend from 2023 to 2031. This growth is driven by increasing demand for effective treatments for atopic dermatitis and other skin conditions. The market size is expected to expand substantially, with forecasts indicating robust growth rates during the forecasted period[1][4].

Market Segmentation

The pimecrolimus market is segmented based on type, application, and geographical regions. Key segments include:

  • Type: Pimecrolimus, Tacrolimus, and Cyclosporine A.
  • Application: Chronic Graft-versus-host Disease, Atopic Dermatitis, Seborrheic Dermatitis, and others.
  • Geographical Regions: North America, Europe, Asia-Pacific, South America, and Middle-East and Africa[1][4].

Effectiveness and Clinical Use

Pimecrolimus has been shown to be more effective than placebo treatments in controlling mild to moderate atopic eczema. It improves global measures such as the Investigators Global Assessment, patient-based measures like the number of flares and pruritus, and quality of life. However, there is limited evidence comparing pimecrolimus directly with topical corticosteroids, which are the most clinically relevant comparators[2][5].

Economic Evaluation and Cost-Effectiveness

Economic modeling suggests that pimecrolimus is unlikely to be cost-effective compared to topical corticosteroids for treating mild to moderate eczema in both children and adults. Pimecrolimus tends to cost more while conferring fewer quality-adjusted life-years (QALYs). However, the absolute differences in QALYs are small and subject to high uncertainty. It may be considered cost-effective if decision-makers are willing to pay more than £20,000 for an additional QALY[2].

Market Drivers

Several factors drive the growth of the pimecrolimus market:

  • Increasing Prevalence of Atopic Dermatitis: The rising incidence of AD globally contributes to the demand for effective treatments.
  • Advancements in Pharmaceutical Technology: Continuous research and development in the pharmaceutical industry lead to improved formulations and delivery methods.
  • Growing Awareness and Healthcare Spending: Increased awareness about skin conditions and higher healthcare spending in various regions fuel market growth[1][4].

Market Restraints

Despite the growth, the market faces several restraints:

  • Cost-Effectiveness Concerns: Pimecrolimus is often more expensive than traditional topical corticosteroids, making it less cost-effective in many cases.
  • Limited Comparative Studies: There is a lack of comprehensive studies comparing pimecrolimus directly with topical corticosteroids, which hampers its adoption.
  • Regulatory Hurdles: Strict regulatory requirements and the need for extensive clinical trials can slow down market entry and expansion[2][4].

Competitive Landscape

The pimecrolimus market is competitive, with several key players:

  • Novartis Pharmaceuticals: Known for its significant involvement in the development and marketing of pimecrolimus.
  • Cayman Chemical: Focuses on strengthening its product portfolio and expanding its business globally.
  • Santa Cruz Biotechnology: Another major player investing in research and development to enhance market presence[1][4].

Regional Analysis

The market is geographically diverse, with different regions exhibiting varying growth patterns:

  • North America and Europe: These regions are expected to dominate the market due to high healthcare spending and advanced healthcare infrastructure.
  • Asia-Pacific: This region is anticipated to show significant growth due to increasing awareness and improving healthcare facilities[1][4].

Financial Performance and Projections

The financial performance of companies involved in the pimecrolimus market is closely tied to the overall market dynamics. For instance, companies like Bausch Health, which have a diversified portfolio including dermatology products, are investing heavily in research and development and marketing to drive growth. The revenue from pimecrolimus and related products is expected to contribute significantly to the overall financial health of these companies[3].

Technological and Regulatory Trends

Technological advancements and regulatory changes play crucial roles in shaping the market:

  • New Formulations and Delivery Methods: Continuous innovation in pharmaceutical technology can lead to more effective and user-friendly products.
  • Regulatory Approvals: Obtaining approvals from regulatory bodies is critical for market entry and expansion. Companies must navigate these regulatory landscapes carefully to ensure compliance and success[1][4].

Consumer Behavior and Preferences

Consumer behavior and preferences significantly influence the market:

  • Patient Compliance: The ease of use and effectiveness of pimecrolimus creams can impact patient compliance and overall market demand.
  • Healthcare Provider Recommendations: Recommendations from healthcare providers play a vital role in the adoption of pimecrolimus over other treatments[5].

Key Takeaways

  • The pimecrolimus market is experiencing rapid growth driven by increasing demand for effective treatments for atopic dermatitis.
  • Despite its effectiveness, pimecrolimus faces challenges related to cost-effectiveness compared to topical corticosteroids.
  • The market is segmented by type, application, and geographical regions, with North America and Europe leading the way.
  • Technological advancements and regulatory changes are crucial for market growth.
  • Consumer behavior and healthcare provider recommendations are key factors influencing market dynamics.

FAQs

What is the primary use of pimecrolimus?

Pimecrolimus is primarily used for the treatment of atopic dermatitis (AD), also known as eczema. It is a topical immunomodulator that helps in reducing the symptoms of AD[5].

Is pimecrolimus cost-effective compared to topical corticosteroids?

Pimecrolimus is generally not considered cost-effective compared to topical corticosteroids. Economic modeling suggests it costs more while conferring fewer quality-adjusted life-years (QALYs)[2].

Which regions are expected to dominate the pimecrolimus market?

North America and Europe are expected to dominate the pimecrolimus market due to high healthcare spending and advanced healthcare infrastructure[1][4].

What are the key drivers of the pimecrolimus market?

Key drivers include the increasing prevalence of atopic dermatitis, advancements in pharmaceutical technology, and growing awareness and healthcare spending[1][4].

Which companies are major players in the pimecrolimus market?

Major players include Novartis Pharmaceuticals, Cayman Chemical, and Santa Cruz Biotechnology, among others[1][4].

Sources

  1. Market Research Intellect: Global Pimecrolimus Market Size, Scope And Forecast Report.
  2. NCBI: The effectiveness and cost-effectiveness of pimecrolimus and ...
  3. Bausch Health: BAUSCH HEALTH COMPANIES INC. AR 2023.
  4. Cognitive Market Research: Global Pimecrolimus Market Report 2024 Edition.
  5. PLOS ONE: Pimecrolimus Cream 1% in the Management of Atopic Dermatitis in ...

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