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PROTOPIC

NDA

TACROLIMUS | N050777 | LEO PHARMA AS

2 strengths0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Protopic (2023)

Total Spending

$11K

Total Claims

Beneficiaries

Avg Cost/Unit

$9.03

Spending Trend

$268K(2019)→$249K(2020)→$306K(2021)→$146K(2022)→$11K(2023)

YoY Change:+2.0%

5yr CAGR:+1.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain23 active DMFs7 inactive

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

ASTELLAS PHARMA INCTACROLIMUS (FK506) DRUG SUBSTANCE

DMF 168332003

BIOCON LTDTACROLIMUS USP

DMF 184422005

CONCORD BIOTECH LTDTACROLIMUS USP

DMF 189082005

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTACROLIMUS

DMF 189852005

LEK PHARMACEUTICALS DDTACROLIMUS

DMF 199792006

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTACROLIMUS SD20

DMF 232132009

HISUN PHARMACEUTICAL HANGZHOU CO LTDTACROLIMUS USP

DMF 272022013

MURLI KRISHNA PHARMA PVT LTDTACROLIMUS PELLETS 5.0% W/W

DMF 276262013

APOTEX INCTACROLIMUS USP

DMF 280652014

TAPI NL BVTACROLIMUS

DMF 285242014

BIOCON LTDTACROLIMUS GRANULES 20% W/W

DMF 297862015

CKD BIO CORPTACROLIMUS NON STERILE API

DMF 310972016

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDTACROLIMUS USP

DMF 312252016

LEK PHARMACEUTICALS DDTACROLIMUS (PROCESS II)

DMF 340632020

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDTACROLIMUS USP

DMF 342702020

CONCORD BIOTECH LTDTACROLIMUS USP (PROCESS II)

DMF 344912020

FARMHISPANIA SATACROLIMUS USP

DMF 358522021

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTACROLIMUS (PROCESS B)

DMF 383102023

LUNAN NEW TIME BIO-TECH CO LTDTACROLIMUS

DMF 389852023

BIOCON LTDTACROLIMUS USP (PROCESS II)

DMF 395732024

WUXI FORTUNE PHARMACEUTICAL CO LTDTACROLIMUS

DMF 398162024

CHENGDU YACHT BIOTECHNOLOGY CO LTDTACROLIMUS

DMF 404482024

FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)TACROLIMUS USP

DMF 418282025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveTACROLIMUS (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 190722005

HANGZHOU HUADONG MEDICINE GROUP BIOTECHNOLOGY INSTITUTE CO LTDInactiveTACROLIMUS

DMF 203902007

ANTIBIOTICOS SPAInactiveTACROLIMUS MONOHYDRATE

DMF 222542008

BIOCON LTDInactiveTACROLIMUS (PRODUCT CODE 8000255)

DMF 233652009

JOYANG LABORATORIESInactiveTacrolimus

DMF 346302020

LUNAN NEW TIME BIO-TECH CO LTDInactiveTACROLIMUS USP

DMF 379822023

FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)InactiveTACROLIMUS USP

DMF 396672024

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Nov 8, 2011	SUPPL -18	View Letter (PDF)
Jan 6, 2009	SUPPL -14	View Letter (PDF)
Jan 30, 2006	SUPPL -12	View Letter (PDF)
Jul 15, 2005	SUPPL -10	View Letter (PDF)
Dec 24, 2003	SUPPL -6	View Letter (PDF)
May 29, 2003	SUPPL -4	View Letter (PDF)
Apr 9, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.03%

RLDAB

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Dec 8, 2000

No patent or exclusivity listings for this strength.

#002 — 0.1%

RLDAB

0 patents0 exclusivities▾

OINTMENT;TOPICAL | Approved: Dec 8, 2000