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Last Updated: December 6, 2019

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ASACOL HD Drug Profile

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Which patents cover Asacol Hd, and what generic alternatives are available?

Asacol Hd is a drug marketed by Apil and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in seventeen countries.

The generic ingredient in ASACOL HD is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Drug patent expirations by year for ASACOL HD
Drug Prices for ASACOL HD

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Drug Sales Revenue Trends for ASACOL HD

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Recent Clinical Trials for ASACOL HD

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SponsorPhase
Chinese University of Hong KongN/A
Queen Elizabeth Hospital, Hong KongN/A
Tseung Kwan O Hospital, Hong KongN/A

See all ASACOL HD clinical trials

Recent Litigation for ASACOL HD

Identify potential future generic entrants

District Court Litigation
Case NameDate
Salix Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-27
Warner Chilcott (US), LLC v. Teva Pharmaceuticals USA, Inc.2015-08-28
Warner Chilcott Company LLC v. Zydus Pharmaceuticals (USA) Inc.2011-11-08

See all ASACOL HD litigation

Pharmacology for ASACOL HD
Drug ClassAminosalicylate
Synonyms for ASACOL HD
1764-EP2272825A2
1764-EP2275420A1
2-Hydroxy-5-aminobenzoic acid
24215-EP2289518A1
24215-EP2295053A1
24215-EP2295409A1
24215-EP2314574A1
24215-EP2314590A1
3-amino-6-hydroxybenzoic acid
3-carboxy-4-hydroxyaniline
35589-28-7 (mono-hydrochloride salt)
3amino-6-hydroxybenzoic acid
4-14-00-02058 (Beilstein Handbook Reference)
4Q81I59GXC
5-?Aminosalicylic Acid (Mesalazine)
5-Amino 2-hydroxy benzoic acid
5-Amino Salicylic Acid
5-amino-2-hydroxy-benzoic acid
5-Amino-2-hydroxybenzoic acid
5-Amino-2-hydroxybenzoic acid 97%
5-amino-2-hydroxybenzoic acid,5-Aminosalicylic acid
5-Amino-2-hydroxybenzoic acid; 5-AS; Mesalamine; 5-ASA
5-amino-2-hydroxybenzoicacid
5-amino-salicylic acid
5-Aminosalicyclic acid
5-Aminosalicylate
5-Aminosalicylic acid
5-Aminosalicylic acid, >=99%
5-Aminosalicylic acid, 95%
5-Aminosalicylic acid, 99%
5-Aminosalicylic acid, analytical standard
5-Aminosalicylic Acid, Purified
5-Aminosalicylic acid, tablet
5-Aminosalicylicacid
5-AS
5-ASA
61513-32-4
6291-36-7 (hydrochloride)
89-57-6
90701-EP2371811A2
A0317
A3613/0153179
AB00374979
AB00374979_11
AB00374979_12
AB00374979-09
AB00374979-10
AB1001921
AC-2764
AC1L1HCS
AC1Q51L9
ACMC-1BKFR
AI3-15564
AJ-08068
AJG-501
AK-72925
AKOS000118959
AM20060091
AN-874
ANW-39326
Apriso
Apriso (TN)
ARONIS23914
Asacol
Asacol (TN)
Asacolitin
BBL013046
BCP05326
BCP9000175
BDBM60918
Benzoic acid, 5-amino-2-hydroxy-
BIDD:GT0811
BP-13074
BPBio1_001164
BR-72925
BRN 2090421
BSPBio_001058
C07138
Canasa
Canasa (TN)
CAS-89-57-6
CCG-100829
CCRIS 7334
CHEBI:6775
CHEMBL704
cid_4075
Claversal
cMAP_000045
CPD000145728
CS-2219
CTK3E8105
D00377
DB00244
Delzicol
Delzicol (TN)
DSSTox_CID_4506
DSSTox_GSID_24506
DSSTox_RID_77435
DTXSID5024506
EC 201-919-1
EINECS 201-919-1
F1918-0003
FC1035
Fisalamine
FT-0619950
GTPL2700
HMS1571E20
HMS2051M21
HMS2090I09
HMS2098E20
HMS3393M21
HMS3649K15
HMS3651M15
HMS3715E20
HS-0100
HSDB 7512
HY-15027
I06-0488
Iialda
InChI=1/C7H7NO3/c8-4-1-2-6(9)5(3-4)7(10)11/h1-3,9H,8H2,(H,10,11
KB-196569
KB-196728
KBio2_002425
KBio2_004993
KBio2_007561
KBio3_002904
KBioGR_002425
KBioSS_002431
KBOPZPXVLCULAV-UHFFFAOYSA-N
KS-00000CC5
KS-000048PQ
KSC448C0L
Lialda
Lialda (TN)
Lixacol
LS-1894
LS11426
M-7246
m-Aminosalicylic acid
MAX-002
MCULE-5752745805
MD-0901
mesalamine
Mesalamine (Lialda)
Mesalamine (TN)
mesalamine (USAN)
Mesalamine (USP)
Mesalamine [USAN:USP]
Mesalamine [USAN]
Mesalamine, Pharmaceutical Secondary Standard; Certified Reference Material
Mesalamine, United States Pharmacopeia (USP) Reference Standard
Mesalamine|||Mesalazine
Mesalazina
Mesalazina [Spanish]
Mesalazine
Mesalazine (JAN/INN)
Mesalazine [INN]
Mesalazine for system suitability, European Pharmacopoeia (EP) Reference Standard
Mesalazine MMX
Mesalazine, European Pharmacopoeia (EP) Reference Standard
Mesalazinum
Mesalazinum [Latin]
Mesasal
Mesavance
Mesavancol
meta-Aminosalicylic Acid
Mezavant
Mezavant XL
MFCD00007877
MFCD00007877 (98%)
MLS000758287
MLS001424012
MolPort-001-641-024
NC00079
NCGC00016344-01
NCGC00016344-02
NCGC00016344-03
NCGC00016344-04
NCGC00016344-05
NCGC00016344-07
NCGC00090934-01
NCGC00090934-02
NCGC00257142-01
NCGC00259159-01
NSC 38877
NSC-38877
NSC-759301
NSC38877
NSC759301
Oprea1_847633
p-Aminosalicylsaeure
p-Aminosalicylsaeure [German]
Pentasa
Pentasa (TN)
Pharmakon1600-01505993
Prestwick0_001069
Prestwick1_001069
Prestwick2_001069
Prestwick3_001069
PubChem17623
Q-201355
Rowasa
Rowasa (TN)
RP21708
RTR-032941
s1681
SALICYLIC ACID, 5-AMINO-
Salofalk
Salofalk Granu-Stix
SAM001247020
SBB052617
SC-15695
SCHEMBL18038934
SCHEMBL31297
sfRowasa
Sfrowasa (TN)
SMR000145728
SPBio_002969
SPD 476
SPD-476
SPD-480
SR-01000763486
SR-01000763486-3
SR-01000763486-4
SR-01000763486-9
ST2411704
ST4109571
STK301678
SW197303-4
SY002854
Tox21_110384
Tox21_110384_1
Tox21_201610
Tox21_303125
TR-032941
TRA0073805
UNII-4Q81I59GXC
WLN: ZR DQ CVQ
Z-206
Z57127471
ZINC1688
Paragraph IV (Patent) Challenges for ASACOL HD
Tradename Dosage Ingredient NDA Submissiondate
ASACOL HD TABLET, DELAYED RELEASE;ORAL mesalamine 021830 2011-07-13

US Patents and Regulatory Information for ASACOL HD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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