Viewing data from:

PIMECROLIMUS

ANDA

PIMECROLIMUS | A209345 | ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ELIDEL(TE code: AB)

Medicare Part D Spending

CMS annual spending data for Pimecrolimus (2023)

Total Spending

$19.4M

Total Claims

61,043

Beneficiaries

35,813

Avg Cost/Unit

$5.70

Spending Trend

$15.2M(2019)→$19.2M(2020)→$19.4M(2021)→$17.5M(2022)→$19.4M(2023)

YoY Change:-7.9%

5yr CAGR:-5.5%

Source: CMS Medicare Part D Spending by Drug (2023). 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

1 letter from Drugs@FDA

Date	Submission	Document
Jan 22, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 27, 2018

No patent or exclusivity listings for this strength.