Viewing data from:

CARAFATE

NDA

SUCRALFATE | N018333 | ABBVIE INC

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

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 Carafate (2023)

Total Spending

$2.3M

Total Claims

5,048

Beneficiaries

1,828

Avg Cost/Unit

$0.88

Spending Trend

$105.3M(2019)→$28.7M(2020)→$6.3M(2021)→$3.1M(2022)→$2.3M(2023)

YoY Change:+11.8%

5yr CAGR:+14.1%

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

API Supply Chain11 active DMFs10 inactive

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

FUJI CHEMICAL INDUSTRIES CO LTDSUCRALFATE

DMF 35421979

ACE JAPAN CO LTDSUCRALFATE (SUCROSE SULFATE ALUMINUM SALT)

DMF 61081985

ARCHIMICA SPASUCRALFATE

DMF 165892003

ZHEJIANG HAISEN PHARMACEUTICAL CO LTDSUCRALFATE NON STERILE BULK DRUG SUBSTANCE

DMF 300562016

ALIVUS LIFE SCIENCES LTDSUCRALFATE USP

DMF 334792019

ALIVUS LIFE SCIENCES LTDSUCRALFATE USP (PROCESS-II)

DMF 375022022

MSN LIFE SCIENCES PRIVATE LTDSUCRALFATE USP

DMF 381522023

SNJ LABS PVT LTDSUCRALFATE USP

DMF 388672023

THINQ PHARMA-CRO LTDSUCRALFATE USP

DMF 401452024

GULBRANDSEN TECHNOLOGIES (INDIA) PRIVATE LTDSUCRALFATE USP

DMF 410322024

SNJ LABS PVT LTDSUCRALFATE (SUF) USP

DMF 426412025

ORION CORP LTDInactiveSUCRALFATE

DMF 54541984

ORGAMOL SAInactiveSUCRALFATE

DMF 58251985

NIPPON KAYAKU CO LTDInactiveSUCRALFATE

DMF 60481985

SHANGHAI NO 6 PHARMACEUTICAL FACTORYInactiveSUCRALFATE

DMF 60571985

UNICHEM LABORATORIES LTDInactiveSUCRALFATE

DMF 63311985

ISTITUTO CHEMICOTHERAPICO ITALIANOInactiveSUCRALFATE

DMF 71861987

NANJING PHARMACEUTICAL FACTORY CO LTDInactiveSUCRALFATE

DMF 72821988

NORTHEAST PHARMACEUTICAL GROUP CO LTDInactiveSUCRALFATE

DMF 75521988

SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORPInactiveSUCRALFATE

DMF 78381988

BK GIULINI GMBHInactiveSUCRALFATE POWDER

DMF 118761996

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 5, 2013	SUPPL -34	View Letter (PDF)
May 1, 2007	SUPPL -32	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1GM

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.