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ASACOL HD

NDA

MESALAMINE | N021830 | 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
ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED et al v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 2:2020cv10176 1 patentANDA 214718mesalamine	D.N.J.	2020-08-07	Terminated 2021-03-18	—

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

Citizen Petitions

4 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Aurobindo Pharma USA, Inc FDA-2022-P-2438 · 5 docket documents Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) requesting that the FDA determine whether Asacol® HD (mesalamine) delayed-release tablets 800 mg, NDA 021830, held by Allergan Pharmaceuticals International Ltd., was withdrawn from sale for safety or effectiveness reasons,	505(q)	2022-10-04	Granted	Aurobindo Pharma USA, Inc
Citizen Petition from Alembic Labs LLC (USA) FDA-2022-P-0929 · 5 docket documents Alembic Labs LLC submitted this citizen petition on May 27, 2022, requesting that the FDA designate the generic mesalamine delayed-release tablets 800 mg marketed by Zydus Pharmaceuticals USA Inc. under ANDA A203286 as an alternate Reference Listed Drug because the original RLD, ASACOL HD (mesalamin	505(q)	2022-05-27	Open	Alembic Labs LLC (USA)
Citizen Petition from US WorldMeds, LLC FDA-2019-P-3192 · 56 docket documents US WorldMeds, LLC filed this citizen petition requesting that the FDA revoke or restrict the marketing authorizations for certain mesalamine products, including brands such as Asacol HD, Apriso, Pentasa, and Lialda, due to alleged impurity concerns and manufacturing issues, and to require additional	Other	2019-12-27	Open	US WorldMeds, LLC
Warner Chilcott Company, LLC - Citizen Petition FDA-2010-P-0111 · 13 docket documents Warner Chilcott Company, LLC filed this section 505(q) citizen petition on February 22, 2010, requesting that the FDA issue a bioequivalence guidance for mesalamine delayed-release tablets and refrain from approving any abbreviated new drug applications referencing Asacol and Asacol HD unless propos	505(q)	2010-03-02	Denied	—

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

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.

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

10 letters from Drugs@FDA

Date	Submission	Document
Nov 17, 2022	SUPPL -20	View Letter (PDF)
Nov 2, 2021	SUPPL -19	View Letter (PDF)
Oct 2, 2020	SUPPL -16	View Letter (PDF)
Apr 23, 2018	SUPPL -12	View Letter (PDF)
Jul 28, 2017	SUPPL -11	View Letter (PDF)
May 6, 2016	SUPPL -10	View Letter (PDF)
Oct 21, 2013	SUPPL -6	View Letter (PDF)
May 28, 2010	SUPPL -5	View Letter (PDF)
Apr 27, 2009	SUPPL -2	View Letter (PDF)
Jun 3, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: May 29, 2008

No patent or exclusivity listings for this strength.