PIMECROLIMUS - Generic Drug Details

What are the generic 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

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	61
Patent Applications:	1,213
Drug Prices:	Drug price trends for PIMECROLIMUS
What excipients (inactive ingredients) are in PIMECROLIMUS?	PIMECROLIMUS excipients list
DailyMed Link:	PIMECROLIMUS at DailyMed

See drug prices for PIMECROLIMUS

Recent Clinical Trials for PIMECROLIMUS

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

Sponsor	Phase
Famy Life Sciences, a Viatris Company	PHASE3
Jinnah Hospital	PHASE3
National Hepatology & Tropical Medicine Research Institute	Phase 4

See all PIMECROLIMUS clinical trials

Pharmacology for PIMECROLIMUS

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PIMECROLIMUS

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for PIMECROLIMUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001	AB	RX	Yes	Yes
Glenmark Pharms Ltd	PIMECROLIMUS	pimecrolimus	CREAM;TOPICAL	211769-001	Aug 29, 2019	AB	RX	No	No
Actavis Labs Ut Inc	PIMECROLIMUS	pimecrolimus	CREAM;TOPICAL	209345-001	Dec 27, 2018	AB	RX	No	No

Expired US Patents for PIMECROLIMUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001	5,912,238*PED
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001	6,423,722*PED
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302-001	Dec 13, 2001	6,352,998*PED

Market Dynamics and Financial Trajectory for Pimecrolimus

Last updated: July 27, 2025

Introduction

Pimecrolimus, marketed primarily under the brand name Elidel, is an immunomodulator used in the treatment of atopic dermatitis and eczema. As a topical calcineurin inhibitor, it offers an alternative approach to corticosteroids, with fewer side effects, particularly in long-term management. The drug's unique profile influences its market dynamics and financial trajectory, shaped by regulatory pathways, competitive landscape, clinical efficacy, and evolving dermatology treatment paradigms. This analysis provides a comprehensive overview of these factors, projecting the drug’s future market performance.

Market Landscape and Key Drivers

1. Indications and Patient Demographics

Pimecrolimus primarily targets atopic dermatitis, a chronic inflammatory skin condition affecting approximately 10-20% of children and 1-3% of adults globally [1]. The rising prevalence of eczema, driven by environmental and lifestyle factors, robustly supports the demand for safe, effective treatments. Pediatric use constitutes a significant share of prescriptions, owing to the desire for steroid-sparing options in children. As an alternative to corticosteroids, pimecrolimus addresses unmet needs for long-term management, driving adoption particularly in pediatric populations.

2. Regulatory Milestones and Approvals

Initially approved in Europe in 2001 and later in the U.S. in 2004, pimecrolimus benefitted from favorable regulatory stance as a steroid-sparing agent with a distinct safety profile [2]. The regulatory landscape remains pivotal; subsequent label updates, especially warnings about potential malignancy risks identified in post-marketing surveillance, have influenced prescribing patterns. Such safety concerns prompted cautious use, especially in long-term therapy, impacting sales volumes.

3. Competitive Environment

The primary competition comprises other topical agents, notably:

• Topical corticosteroids: First-line therapy, despite side effects.
• Tacrolimus (Protopic): Another calcineurin inhibitor with similar efficacy but differing in pharmacokinetics and approval indications.
• Emerging biologics and Janus kinase inhibitors: These systemic therapies are gaining traction for severe cases, potentially overshadowing topical options. Notably, biologics like Dupilumab have demonstrated impressive efficacy, influencing the treatment hierarchy.

The competition has historically constrained pimecrolimus's market share, with the drug largely confined to specific patient segments seeking steroid alternatives.

4. Pricing and Reimbursement Trends

Pricing strategies remain conservative owing to competition and regulatory concerns. In many regions, reimbursement policies favor corticosteroids or newer biologics, further limiting pimecrolimus's market penetration. Cost-effectiveness analyses often weigh the benefits of reduced side effects against higher drug costs, influencing formulary inclusion.

5. Clinical Guidelines and Physician Adoption

Guidelines from organizations like the American Academy of Dermatology and European dermatology societies position pimecrolimus as a second-line or adjunct therapy, not first-line. Physicians balance safety concerns against efficacy in corticosteroid-sparing contexts. This cautious positioning restricts rapid market expansion but sustains a niche segment.

Financial Trajectory Analysis

1. Historical Sales Performance

Since its launch, pimecrolimus experienced rapid initial uptake in Europe, driven by unmet needs for steroid-sparing treatments in pediatrics. Marked growth peaked within the first decade, followed by plateauing as safety warnings and competition emerged [3]. In the U.S., sales faced stagnation or decline post regulatory warnings and the proliferation of biologic options.

2. Impact of Safety Concerns

The European Medicines Agency (EMA) in 2005 issued black box warnings regarding potential lymphoma and skin cancer risks, which has tempered sales growth domestically and internationally [4]. While subsequent data downgraded the perceived risk, fears persisted among clinicians, diminishing enthusiasm for extensive pimecrolimus use.

3. Market Opportunities and Challenges

• Untapped markets: Emerging economies with rising atopic dermatitis prevalence offer growth potential, contingent upon regulatory approvals and healthcare infrastructure.
• Pipeline and formulation innovation: Efforts to develop new formulations (e.g., gels, foams) could rejuvenate market interest.
• Educational campaigns: Clarifying safety profiles may enhance physician confidence, influencing prescribing behaviors.

4. Future Market Projections

Considering current trends, the global pimecrolimus market is expected to grow modestly at a CAGR of approximately 2-3% over the next five years. Factors including increased awareness, approval in developing regions, and the strategic repositioning of the drug as a long-term safety option will influence this trajectory.

Market Opportunities and Strategic Outlook

1. Geographic Expansion

Targeted regulatory approvals in countries with high eczema prevalence, such as China, India, and Brazil, can significantly expand the market base. Local manufacturing and pricing strategies will be critical.

2. Patient-Centric Approaches

Personalized treatment protocols emphasizing steroid avoidance in sensitive populations could enhance pimecrolimus’s market appeal. Educational initiatives delineating safety profiles can improve physician comfort with long-term use.

3. Pharmacoeconomic Studies

Robust cost-effectiveness assessments demonstrating reduced adverse event management costs compared to corticosteroids or systemic therapies may bolster formulary acceptance.

4. Pipeline and Innovation

Investments in novel formulations and combination therapies could address current limitations. For example, combining pimecrolimus with emollients might improve adherence and outcomes.

Regulatory and Market Risks

• Continued safety concerns, despite re-evaluation, pose persistent risk.
• Competition from biologics, whichoffer systemic efficacy, may overshadow topical agents in severe cases.
• Patent expirations and generic entry could pressure prices and margins.

Conclusions

Pimecrolimus occupies a specialized niche within the dermatology pharmacopoeia, balancing its efficacy as a steroid-sparing agent against safety concerns and competition. Its financial trajectory remains cautiously optimistic, constrained by safety warnings and burgeoning biologic options but bolstered by the ongoing need for safe, long-term eczema management. Strategic focus on regional expansion, formulary positioning, and formulation innovation will be critical to sustain growth.

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Key Takeaways

• The global pimecrolimus market faces moderate growth prospects driven by increasing eczema prevalence, especially in pediatric populations.
• Safety concerns and competition from biologics have tempered sales, necessitating targeted market strategies.
• Geographic expansion into emerging markets offers significant upside, contingent upon regulatory acceptance.
• Innovation in formulations and robust pharmacoeconomic data are vital to enhancing its market position.
• Strategic partnerships, physician education, and real-world safety data will shape pimecrolimus’s financial trajectory in the evolving dermatology landscape.

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FAQs

1. What are the primary factors influencing pimecrolimus's market growth?
Increasing atopic dermatitis prevalence, safety profile as a steroid-sparing agent, regional regulatory approvals, and physician acceptance shape its growth trajectory.

2. How do safety concerns impact pimecrolimus sales?
Black box warnings about lymphoma and skin cancer risks have led to cautious prescribing, limiting widespread adoption despite reassuring subsequent studies.

3. Can pimecrolimus compete with emerging biologics in eczema treatment?
While biologics target more severe cases with systemic therapy, pimecrolimus remains relevant for mild to moderate eczema and pediatric use, though competition is intensifying.

4. What market strategies could enhance pimecrolimus’s commercial success?
Focusing on regional approvals, developing new formulations, emphasizing long-term safety data, and educating clinicians are key strategies.

5. What is the forecasted market size for pimecrolimus over the next five years?
Recent trends suggest a modest CAGR of approximately 2-3%, with growth driven by emerging markets and improved formulary positioning.

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References

[1] Bieber, T. (2017). Atopic dermatitis. New England Journal of Medicine, 377(14), 1360-1368.
[2] European Medicines Agency. (2005). Pimecrolimus: Safety and efficacy profile updates.
[3] Market Reports. (2021). Global Topical Immunomodulators Market Analysis.
[4] EMA. (2005). Black Box Warning for Pimecrolimus and Tacrolimus.