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DELZICOL

NDA

MESALAMINE | N204412 | 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Warner Chilcott (US), LLC et al v. Teva Pharmaceuticals USA, Inc. et al 2:2015cv01471 1 patentANDA 207873mesalamine delayed release capsules	E.D. Tex.	2015-08-28	Terminated 2019-03-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

57 trials from ClinicalTrials.gov, 44 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)NCT01327300	Phase 2	Completed	University of Florida	7	2010-03 → 2012-03
A Comparison of Once a Day Dose Compared to 2 Doses/Day NCT00505778	Phase 3	Completed	Warner Chilcott	1,027	2007-07 → 2009-07
Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis NCT01209208	Phase 3	Completed	Dr. Falk Pharma GmbH	57	2010-05 → 2017-06
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study NCT01412372	Phase 3	Completed	University of Utah	61	2010-06 → 2019-04-22
Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations NCT00802451	N/A	Completed	Padagis LLC	48	2003-02 → 2003-03
Targeting Oxidative Stress in Chronic Beryllium Disease NCT01088243	Phase 1/2	Completed	National Jewish Health	18	2010-03 → 2015-03
A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M NCT02493712	Phase 2	Completed	Holy Stone Healthcare Co., Ltd	51	2016-01 → 2019-04
Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis NCT01020708	Phase 1	Completed	Altheus Therapeutics, Inc.	9	2009-11 → 2010-09
Taste Assessment Study of SHP429 in Healthy Adult Subjects NCT02125292	Phase 1	Completed	Shire	18	2014-06-02 → 2014-06-19
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis NCT00151892	Phase 3	Completed	Shire	829	2005-04-08 → 2009-09-07

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$2.35

per ea

Lowest NADAC/Unit

$2.35

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762011701MESALAMINE DR 400 MG CAPSULE	$2.35	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

Medicare Part D Spending

CMS annual spending data for Delzicol (2024)

Total Spending

$644K

Total Claims

584

Beneficiaries

214

Avg Cost/Unit

$3.63

Spending Trend

$29.7M(2019)→$5.5M(2020)→$2.7M(2021)→$1.8M(2022)→$1.5M(2023)→$644K(2024)

YoY Change:-6.0%

5yr CAGR:-0.6%

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

API Supply Chain23 active DMFs13 inactive

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

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

CORDEN PHARMA BERGAMO SPAInactiveMESALAMINE

DMF 118071996

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

9 letters from Drugs@FDA

Date	Submission	Document
Oct 25, 2023	SUPPL -17	View Letter (PDF)
Nov 17, 2022	SUPPL -16	View Letter (PDF)
Nov 2, 2021	SUPPL -15	View Letter (PDF)
Oct 2, 2020	SUPPL -12	View Letter (PDF)
Jul 28, 2017	SUPPL -8	View Letter (PDF)
Sep 10, 2015	SUPPL -6	View Letter (PDF)
Oct 28, 2014	SUPPL -4	View Letter (PDF)
Apr 29, 2014	SUPPL -3	View Letter (PDF)
Feb 5, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 400MG

RLD

0 patents0 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Feb 1, 2013

No patent or exclusivity listings for this strength.