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Drug ReportsMesalamine
Mesalamine
Apriso, Canasa, Lialda, Mesalamine, Pentasa, Rowasa, Sfrowasa (mesalamine) is a small molecule pharmaceutical. Mesalamine was first approved as Rowasa on 1987-12-24. It is used to treat proctitis, sigmoid diseases, and ulcerative colitis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
Trade Name
FDA
EMA
Apriso, Canasa, Lialda, Mesalamine, Pentasa, Sfrowasa (discontinued: Asacol, Canasa, Delzicol, Mesalamine, Rowasa)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mesalamine
Tradename
Company
Number
Date
Products
CANASAAbbVieN-021252 RX2004-11-05
1 products, RLD, RS
ROWASAMylanN-019618 RX1987-12-24
1 products, RLD, RS
SFROWASAMylanN-019618 RX2008-06-20
1 products, RLD
APRISOSalix PharmaceuticalsN-022301 RX2008-10-31
1 products, RLD, RS
LIALDATakedaN-022000 RX2007-01-16
1 products, RLD, RS
PENTASATakedaN-020049 RX1993-05-10
2 products, RLD
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
aprisoNew Drug Application2024-01-09
asacolNew Drug Application2014-03-07
canasaNew Drug Application2024-09-08
delzicolNew Drug Application2016-08-06
lialdaNew Drug Application2023-10-24
mesalamineANDA2025-09-15
mesalamine rectalANDA2023-12-15
pentasaNew Drug Application2025-01-15
rowasaNew Drug Application2024-07-15
sfrowasaNew Drug Application2024-07-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ulcerative colitisEFO_0000729D003093K51
proctitisEFO_0005628D011349K62.89
sigmoid diseases—D012810—
Agency Specific
FDA
EMA
Expiration
Code
MESALAMINE, LIALDA, TAKEDA PHARMS USA
2023-06-26NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Mesalamine, Apriso, Valeant Pharms Intl
88656882030-05-01U-1310
Mesalamine, Canasa, Abbvie
82170832028-06-06DP
84360512028-06-06DP
Mesalamine, Rowasa, Mylan Speciality Lp
76458012027-07-24DS, DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07E: Intestinal antiinflammatory agents
— A07EC: Aminosalicylic acid and similar agents
— A07EC02: Mesalazine
HCPCS
No data
Clinical
Clinical Trials
231 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ulcerative colitisD003093EFO_0000729K51——1——1
ColitisD003092EFO_0003872K52.9——1——1
UlcerD014456MPATH_579———1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMesalamine
INNmesalazine
Description
Mesalamine is a monohydroxybenzoic acid that is salicylic acid substituted by an amino group at the 5-position. It has a role as a non-steroidal anti-inflammatory drug. It is an aromatic amine, an amino acid, a member of phenols, a monocarboxylic acid and a monohydroxybenzoic acid. It is functionally related to a salicylic acid. It is a conjugate acid of a mesalaminate(1-).
Classification
Small molecule
Drug classanti-inflammatory agents (salicylic acid derivatives)
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Structure (InChI/SMILES or Protein Sequence)
Nc1ccc(O)c(C(=O)O)c1
Identifiers
PDB—
CAS-ID89-57-6
RxCUI—
ChEMBL IDCHEMBL704
ChEBI ID6775
PubChem CID4075
DrugBankDB00244
UNII ID4Q81I59GXC (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
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Canasa – Allergan
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Canasa – Warner Chilcott
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Asacol – Allergan
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Asacol – Warner Chilcott
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Pentasa – Shire
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Lialda – Shire
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Tabular view
Estimated US medical usage
Mesalamine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,959 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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23,378 adverse events reported
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