Pimecrolimus

Treats mild to moderate atopic dermatitis in non-immunocompromised adults and children 2…. Sold as Elidel. Every FDA application for this active ingredient: 1 branded and 2 generic.

As of Nov 14, 2026, FDA lists 3 applications for Pimecrolimus (sold as Elidel), first approved Dec 13, 2001, with 0 new uses approved and 0 published complete response letters.

First approved: Dec 13, 2001
Applications: 3
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $22.4M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Pimecrolimus	Part D	$22.4M	+35%	60,260
Elidel	Part D	$25K	-70%	12

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

PIMECROLIMUS 1% CREAM: $3.32 per GMGeneric · +21% in a year

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Treatment of Vulvar Lichen Sclerosus With Corticosteroid Ointment, Calcineurin Inhibitor Ointment, and Platelet-Rich Plasma (PRP) Therapy.Vulvar Lichen Sclerosus · Milosz Pietrus	Not applicable	Not yet recruiting	Nov 20, 2025
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK InhibitorDermatitis Atopic · Sanofi	Phase 3	Active, not recruiting	Feb 5, 2024
Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With Atopic Dermatitis.Mild to Moderate Atopic Dermatitis · BGP Products Operations GmbH, a Viatris company	—	Active, not recruiting	Sep 25, 2023
10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used PimecrolimusAtopic Dermatitis · Bausch Health Americas, Inc.	—	Active, not recruiting	Dec 6, 2007

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 13, 2001	ElidelNDA 21302 · New molecular entity	Bausch	12	Marketed
Dec 27, 2018	PimecrolimusANDA 209345	Actavis Labs Ut Inc	0	Marketed
Aug 29, 2019	PimecrolimusANDA 211769	Glenmark Pharms Ltd	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA