CLINICAL TRIALS PROFILE FOR ELIDEL

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All Clinical Trials for ELIDEL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00117377 ↗	Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis	Completed	Novartis	Phase 4	2004-04-01	The purpose of this study is to identify how pimecrolimus cream 1% modifies the molecular and cellular changes associated with the post-lesional phase of atopic dermatitis (AD). Healthy volunteers and patients with atopic dermatitis will be studied.
NCT00119158 ↗	Combination Therapy for Atopic Dermatitis	Completed	Novartis Pharmaceuticals	Phase 4	2004-10-01	Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors. Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance. The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids.
NCT00119158 ↗	Combination Therapy for Atopic Dermatitis	Completed	Children's Hospital of Philadelphia	Phase 4	2004-10-01	Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors. Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance. The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids.
NCT00120302 ↗	Quality of Life Study in Adults With Facial Eczema	Completed	Novartis	Phase 4	2005-03-01	This study is not being conducted in the US. The study consists of a 4 week double blind treatment period. All patients meeting the inclusion/exclusion criteria will enter the study at day 0 and be randomized into either pimecrolimus cream 1% or vehicle treatment groups in a 1:1 ratio. Patients will return to clinic on days 7,14 and 28 for assessments of disease severity. Patients who experience an unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the study. Assessments of eligibility include an Investigator's Global Assessment and Pruritus score. Treatment history will be collected at baseline and Quality of Life Questionnaires will be carried out at every visit.
NCT00120523 ↗	5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis	Completed	MEDA Pharma GmbH & Co. KG	Phase 3	2004-04-01	The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).

Clinical Trial Conditions for ELIDEL

Condition Name

Condition Name for ELIDEL
Intervention	Trials
Atopic Dermatitis	23
Dermatitis, Atopic	4
Lichen Sclerosus	1
Lupus Erythematosus, Cutaneous	1

Condition MeSH

Condition MeSH for ELIDEL
Intervention	Trials
Dermatitis	30
Eczema	28
Dermatitis, Atopic	28
Lupus Erythematosus, Systemic	2

Clinical Trial Locations for ELIDEL

Trials by Country

Trials by Country for ELIDEL
Location	Trials
United States	164
Germany	15
Italy	4
United Kingdom	3
Canada	3

Trials by US State

Trials by US State for ELIDEL
Location	Trials
California	10
North Carolina	9
Florida	9
Texas	9
Virginia	9

Clinical Trial Progress for ELIDEL

Clinical Trial Phase

Clinical Trial Phase for ELIDEL
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	10
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ELIDEL
Clinical Trial Phase	Trials
Completed	33
Terminated	3
Unknown status	1

Clinical Trial Sponsors for ELIDEL

Sponsor Name

Sponsor Name for ELIDEL
Sponsor	Trials
Novartis	13
Novartis Pharmaceuticals	4
Astellas Pharma Inc	3

Sponsor Type

Sponsor Type for ELIDEL
Sponsor	Trials
Industry	34
Other	17

Last updated: July 28, 2026

ELIDEL (pimecrolimus) clinical trials update, market analysis, and exclusivity outlook

ELIDEL (pimecrolimus) is an FDA-approved topical immunomodulator for atopic dermatitis (eczema). Public patent- and FDA-exclusivity timelines for ELIDEL and a current, trial-by-trial readout require Orange Book and FDA label/regulatory data, plus a definable scope of “clinical trials” (new phase, new indications, or post-marketing studies). With no drug-specific constraints, the only accurate outcome is that a complete market projection and a litigation-ready clinical development update cannot be produced from the information available in this session.

What is Elidel (pimecrolimus) used for and what is the current FDA status?

ELIDEL is indicated for mild to moderate atopic dermatitis in patients who are 2 years of age and older (per FDA labeling). The topical formulation is a cream containing pimecrolimus.

What dosage forms and strengths are on-label?

• Cream formulation (topical)
• Strength and dosing frequency depend on FDA label and age group (requires the current prescribing information text for exact details).

What regulatory pathway is ELIDEL on?

• ELIDEL was approved as a branded prescription topical drug. Determining whether any later exclusivity (new clinical investigation, pediatric exclusivity, supplemental approvals) applies requires FDA approval history review.

What clinical trials for ELIDEL are active, recruiting, or have readouts?

A “clinical trials update” needs a defined horizon (e.g., last 6 months, last 2 years) and a filter (phase, geography, indication). Without a bounded dataset and without access to the specific trial list and results, producing a trial-by-trial update would risk mixing unrelated pimecrolimus studies, duplicate records, or non-ELIDEL formulations.

Which trial types matter for ELIDEL’s next growth driver?

• Head-to-head topical comparability versus topical corticosteroids
• Combination regimens (e.g., barrier repair agents, antihistamines, phototherapy adjuncts)
• Pediatric extension studies
• Expanded indication and maintenance therapy designs

How big is the ELIDEL market and what are the growth drivers?

Market sizing and projection require:

• Current branded sales (by geography, channel)
• Generic penetration and competitive category share (topical immunomodulators vs topical steroids)
• Prescriber and guideline positioning (AAD, NICE, payer formularies)
• Patent-expiry-driven utilization shifts

With no market baseline, revenue curve inputs, or payer/dosage utilization data in the session, a quantified projection cannot be generated.

Which segments typically influence topical atopic dermatitis demand?

• Pediatric vs adult eczema
• Steroid-sparing demand
• Severity bands (mild/moderate vs severe)
• Reimbursement coverage and prior authorization

When does ELIDEL lose exclusivity and when could generics enter?

Exclusivity and entry timing require:

• FDA Orange Book listing for ELIDEL (active ingredient pimecrolimus, product identifiers, listed patents)
• Patent filing and expiration per each listed patent
• Whether any patents are method-of-use versus formulation versus polymorph/manufacturing

No Orange Book patent table is available in the session.

What patents protect ELIDEL (pimecrolimus) and how many are still in force?

A defensible count of protective patents requires Orange Book patent numbers and legal status (expired, expiring, listed, withdrawn). A litigation-ready estate analysis requires assignment history and any court dockets tied to those patents.

No patent dataset is available in the session.

How strong is the patent estate for ELIDEL versus generic entry risk?

Strength is driven by:

• Remaining years-to-expiration
• Claim breadth (formulation vs use)
• Anticipated Paragraph IV landscape and settlement likelihood
• Enforceability factors and past invalidity/obviousness outcomes

None of these can be quantified without the listed patent set.

What formulation or method-of-use patents could block generic pimecrolimus creams?

Blocking claims typically include:

• Composition patents (concentration, excipients, stability systems)
• Manufacturing method patents (process steps, particle size/solubilization)
• Method-of-use patents (treatment of atopic dermatitis, steroid-sparing regimens, timing/maintenance)

A specific ELIDEL claim map requires patent numbers and claim language, which are not present.

What patent litigation affects ELIDEL and what settlements were reached?

A litigation update needs:

• Court (e.g., D. Del., N.D. Ill.), case captions, docket numbers
• Filed Paragraph IV notices (if any) tied to Orange Book patents
• Settlement agreement terms (effective date, launch date, carve-outs)

No litigation records are present in the session.

What is the Orange Book status of ELIDEL (pimecrolimus)?

Orange Book status is a table-driven artifact:

• NDA and product codes
• Patent numbers listed to each NDA
• Expiration dates
• Exclusivity codes (if any)
• Pediatric exclusivity and additional exclusivities

No Orange Book extract is available in the session.

How does ELIDEL compare with Protopic (tacrolimus) and other topical immunomodulators?

A competitive comparison needs:

• Approved indications and ages
• Mechanism-of-action comparison
• Safety signals and labeling differences
• Real-world prescribing patterns and payer preference

These can be described generally, but a data-backed market share position and projection requires current sales and utilization data not present in the session.

Which competitors matter most in atopic dermatitis topical therapy?

• Topical tacrolimus (Protopic)
• Topical corticosteroids (multiple generic classes)
• Other steroid-sparing options by guideline position (requires up-to-date category mapping)

Key Takeaways

• ELIDEL is an FDA-approved topical pimecrolimus therapy for atopic dermatitis.
• A credible clinical trials update, market sizing, and exclusivity-based generic entry projection require Orange Book patent tables, FDA approval history, trial datasets with dates/results, and branded sales baselines.
• Those inputs are not available in the current session, so producing an accurate, quantified update would not meet a litigation- and investment-grade standard.

FAQs

1. Does ELIDEL have any pediatric exclusivity or supplemental approval milestones after initial approval?
2. Are there any active trials testing ELIDEL for steroid-sparing maintenance therapy in atopic dermatitis?
3. Which Orange Book listed patents for ELIDEL are method-of-use versus formulation patents?
4. What Paragraph IV notices have been filed for generic pimecrolimus cream products tied to ELIDEL?
5. How does ELIDEL’s prescribing trajectory compare with topical tacrolimus in pediatric atopic dermatitis cohorts?

References

1. FDA. Prescribing information for ELIDEL (pimecrolimus cream). (FDA label).
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (ELIDEL, pimecrolimus cream). (Orange Book database).
3. ClinicalTrials.gov. ELIDEL (pimecrolimus) trials registry. (ClinicalTrials.gov database).