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MESALAMINE

ANDA

MESALAMINE | A076751 | PADAGIS ISRAEL PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ROWASA(TE code: AB)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Novitium Pharma LLC FDA-2020-P-1775 Novitium Pharma LLC submitted this citizen petition on August 19, 2020 under 21 C.F.R. § 10.30 requesting that the FDA designate the generic product Mesalamine Enema 4 g/60 mL manufactured by Perrigo Israel Pharmaceuticals Ltd (ANDA #076751) as a reference standard because the original reference lis	Other	2020-08-19	Withdrawn	Novitium Pharma LLC

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

Medicare Part D Spending

CMS annual spending data for Mesalamine (2023)

Total Spending

$1.0M

Total Claims

2,185

Beneficiaries

1,086

Avg Cost/Unit

$74.17

Spending Trend

$1.9M(2019)→$1.6M(2020)→$1.5M(2021)→$1.2M(2022)→$1.0M(2023)

YoY Change:-15.0%

5yr CAGR:+15.1%

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

API Supply Chain24 active DMFs12 inactive

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

CORDEN PHARMA BERGAMO SPAMESALAMINE

DMF 118071996

CHEMI SPAMESALAMINE USP

DMF 119511996

ERREGIERRE SPAMESALAMINE USP-EP

DMF 138831998

SYNTESE ASMESALAMINE (5-AMINOSALICYLIC ACID) DRUG SUBSTANCE

DMF 196182006

IPCA LABORATORIES LTDMESALAMINE USP (PROCESS II)

DMF 226172010

ZYDUS LIFESCIENCES LTDMESALAMINE USP

DMF 229992009

ALP PHARM BEIJING CO LTDMESALAMINE

DMF 242562010

ERREGIERRE SPAMESALAMINE USP - PH.EUR. (HIGH DENSITY)

DMF 248892011

CHEMI SPAMESALAMINE CRYSTALLIZED, USP

DMF 253852011

ZYDUS LIFESCIENCES LTDMESALAMINE USP (PROCESS-II)

DMF 279392014

CTX LIFE SCIENCES PVT LTDMESALAMINE USP

DMF 290512015

SUN PHARMACEUTICAL INDUSTRIES LTDMESALAMINE USP

DMF 295752015

DIVIS LABORATORIES LTDMESALAMINE USP

DMF 299982015

MAITHRI DRUGS PRIVATE LTDMESALAMINE USP

DMF 315702017

APITORIA PHARMA PRIVATE LTDMESALAMINE USP

DMF 339102019

ALKEM LABORATORIES LTDMESALAMINE USP

DMF 339392019

MATRIX PHARMACORP PRIVATE LTDMESALAMINE USP

DMF 343742019

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)MESALAMINE

DMF 347922020

OPTIMUS DRUGS PRIVATE LTDMESALAMINE

DMF 351362020

SOLARA ACTIVE PHARMA SCIENCES LTDMESALAMINE USP

DMF 357172021

ZHEJIANG HENGKANG PHARMACEUTICAL CO LTDMESALAMINE USP

DMF 373192022

DASAMI LAB PRIVATE LTDMESALAMINE USP

DMF 374132022

IOL CHEMICALS AND PHARMACEUTICALS LTDMESALAMINE USP

DMF 383382023

MSN LIFE SCIENCES PRIVATE LTDMESALAMINE USP

DMF 396702024

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveMESALAMINE USP (5-AMINO SALICYLIC ACID)

DMF 164312003

SIMS SRLInactiveMESALAMINE

DMF 180542005

DR REDDYS LABORATORIES LTDInactiveMESALAMINE

DMF 183872005

IPCA LABORATORIES LTDInactiveMESALAMINE USP

DMF 192612006

CORDEN PHARMA BERGAMO SPAInactiveMESALAMINE HIGH DENSITY

DMF 199932006

LUPIN MANUFACTURING SOLUTIONS LTDInactiveMESALAMINE USP

DMF 214892008

LUPIN LTDInactiveMESALAMINE USP

DMF 215142008

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveMESALAMINE USP

DMF 246642011

IPCA LABORATORIES LTDInactiveMESALAMINE USP (MZ3 PROCESS)

DMF 272452013

SIGNA SA DE CVInactiveMESALAMINE USP

DMF 296762016

WANBURY LTDInactiveMESALAMINE

DMF 318872017

BEC CHEMICALS PRIVATE LTDInactiveMESALAMINE USP

DMF 362572023

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 17, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4GM/60ML

0 patents0 exclusivities▴

ENEMA;RECTAL | Approved: Sep 17, 2004

No patent or exclusivity listings for this strength.