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ELIDEL

NDA

PIMECROLIMUS | N021302 | BAUSCH HEALTH US LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Foley Hoag, LLP FDA-2021-P-0268 · 5 docket documents Foley Hoag LLP filed this petition on March 4, 2021 requesting that the FDA withdraw approval of all medications containing lurbinectedin, marketed as Zepzelca under NDA 21302, and place the drug on the list of products withdrawn for safety or effectiveness reasons to prevent compounding under secti	505(q)	2021-03-05	Partially Denied	Foley Hoag, LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

52 trials from ClinicalTrials.gov, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus NCT00608673	N/A	Completed	Shahid Beheshti University of Medical Sciences	10	2006-04 → 2007-11
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis NCT03107611	Phase 3	Completed	Mylan Inc.	654	2016-02-29 → 2017-05-15
Pimecrolimus Cream for Oral Lichen Planus NCT00297037	Phase 2	Completed	University of Utah	21	2005-08 → 2009-02
Efficacy of Elidel Cream on Erosive Oral Lichen Planus NCT00130572	Phase 3	Completed	University Hospital Tuebingen	20	2004-06 → 2007-12
Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus NCT00393263	Phase 2	Completed	Center for Vulvovaginal Disorders	38	2006-10 → 2009-10
Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease NCT00507832	Phase 2	Completed	University Hospital Muenster	30	2007-04 → 2009-10
Assessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-old NCT00510003	Phase 4	Completed	Novartis Pharmaceuticals	117	2004-12
Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)NCT01082393	Phase 4	Completed	University Hospital, Ghent	14	2010-02-16 → 2015-12-01
Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion NCT00925730	Phase 4	Completed	Novartis	20	2004-03
Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis NCT00117377	Phase 4	Completed	Novartis	70	2004-04 → 2005-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$28.41

Highest Price

$173.18

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68682-0110-01PIMECROLIMUS 1% CREAM,TOP	$56.28	FSS	Bausch Health US, LLC	04/30/2026
68682-0110-01PIMECROLIMUS 1% CREAM,TOP	$28.41	Big4	Bausch Health US, LLC	04/30/2026
68682-0111-02PIMECROLIMUS 1% CREAM,TOP	$108.23	FSS	Bausch Health US, LLC	04/30/2026
68682-0111-02PIMECROLIMUS 1% CREAM,TOP	$48.26	Big4	Bausch Health US, LLC	04/30/2026
68682-0112-03PIMECROLIMUS 1% CREAM,TOP	$173.18	FSS	Bausch Health US, LLC	04/30/2026
68682-0112-03PIMECROLIMUS 1% CREAM,TOP	$37.05	Big4	Bausch Health US, LLC	04/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Elidel (2024)

Total Spending

$84K

Total Claims

118

Beneficiaries

Avg Cost/Unit

$9.07

Spending Trend

$7.3M(2019)→$1.7M(2020)→$1.1M(2021)→$1.0M(2022)→$870K(2023)→$84K(2024)

YoY Change:-9.1%

5yr CAGR:-1.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

BIOCON LTDPIMECROLIMUS USP

DMF 293902015

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDPIMECROLIMUS INTERMEDIATE ASCOMYCIN

DMF 294332015

MEDICHEM SAPIMECROLIMUS (MED 201445/E)

DMF 294812015

CONCORD BIOTECH LTDPIMECROLIMUS USP

DMF 296582015

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDPIMECROLIMUS (NON-STERILE, API)

DMF 300902015

CURIA ITALY SRLPIMECROLIMUS

DMF 323482017

CHENGDU YACHT BIOTECHNOLOGY CO LTDPIMECROLIMUS

DMF 419462025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Apr 2, 2014	SUPPL -18	View Letter (PDF)
Jul 23, 2010	SUPPL -14	View Letter (PDF)
Aug 14, 2007	SUPPL -12	View Letter (PDF)
Jan 30, 2006	SUPPL -11	View Letter (PDF)
Dec 2, 2004	SUPPL -5	View Letter (PDF)
Oct 17, 2003	SUPPL -4	View Letter (PDF)
Dec 13, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLDAB

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 13, 2001

No patent or exclusivity listings for this strength.