➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Medtronic
Mallinckrodt
Baxter
McKinsey

Last Updated: May 29, 2020

DrugPatentWatch Database Preview

Mesalamine - Generic Drug Details

» See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for mesalamine and what is the scope of freedom to operate?

Mesalamine is the generic ingredient in ten branded drugs marketed by Apil, Teva Pharms Usa, Valeant Pharms Intl, Mylan, Shire, G And W Labs Inc, Perrigo Israel, Mylan Speciality Lp, Allergan, Amneal Pharms Llc, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz Inc, Zydus Pharms, Meda Pharms, Actavis Labs Fl, and Sun Pharm, and is included in twenty-five NDAs. There are nine patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mesalamine has ninety-six patent family members in twenty-eight countries.

There are twenty-eight drug master file entries for mesalamine. Twenty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for mesalamine

See drug prices for mesalamine

Drug Sales Revenue Trends for mesalamine

See drug sales revenues for mesalamine

Recent Clinical Trials for mesalamine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AllerganPhase 1
Assembly BiosciencesPhase 1
Dayanand Medical College and HospitalPhase 3

See all mesalamine clinical trials

Recent Litigation for mesalamine

Identify potential future generic entrants

District Court Litigation
Case NameDate
Salix Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-27
APTALIS PHARMA US, INC. v. ZYDUS PHARMACEUTICALS (USA), INC.2017-01-30
Shire Development, LLC v. Watson Laboratories, Inc. - FL2016-04-04

See all mesalamine litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2016-11-04
2016-07-11
2016-07-08

See all mesalamine litigation

Generic filers with tentative approvals for MESALAMINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial375MGCAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for mesalamine
Drug ClassAminosalicylate
Medical Subject Heading (MeSH) Categories for mesalamine
Synonyms for mesalamine
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
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-hydroxobenzoic acid monohydrate
5-amino-2-hydroxy-benzoic acid
5-Amino-2-hydroxybenzoic acid
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-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-aminosalicylic_acid
5-Aminosalicylicacid
5-AS
5-ASA
89-57-6
90701-EP2371811A2
A0317
AB00374979
AB00374979_11
AB00374979_12
AB00374979-09
AB00374979-10
AB1001921
AC-2764
ACMC-1BKFR
AI3-15564
AJG-501
AK-72925
AKOS000118959
AM20060091
ANW-39326
Apriso
Apriso (TN)
ARONIS23914
Asacol
Asacol (TN)
Asacol HD
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
Fisalamine
FT-0619950
GTPL2700
HMS1571E20
HMS2051M21
HMS2090I09
HMS2098E20
HMS3393M21
HMS3649K15
HMS3651M15
HMS3715E20
HS-0100
HSDB 7512
HY-15027
Iialda
InChI=1/C7H7NO3/c8-4-1-2-6(9)5(3-4)7(10)11/h1-3,9H,8H2,(H,10,11
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 (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(Lialda)
Mesalamine|||Mesalazine
Mesalazin
Mesalazina
Mesalazina [Spanish]
Mesalazine
Mesalazine (JP17/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
MLS000758287
MLS001424012
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
Q412479
Rowasa
Rowasa (TN)
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 MESALAMINE
Tradename Dosage Ingredient NDA Submissiondate
DELZICOL CAPSULE, DELAYED RELEASE;ORAL mesalamine 204412 2014-06-17
CANASA SUPPOSITORY;RECTAL mesalamine 021252 2013-05-24
APRISO CAPSULE, EXTENDED RELEASE;ORAL mesalamine 022301 2012-04-03
ASACOL HD TABLET, DELAYED RELEASE;ORAL mesalamine 021830 2011-07-13
LIALDA TABLET, DELAYED RELEASE;ORAL mesalamine 022000 2009-12-16
ASACOL TABLET, DELAYED RELEASE;ORAL mesalamine 019651 2007-06-22

US Patents and Regulatory Information for mesalamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc MESALAMINE mesalamine SUPPOSITORY;RECTAL 202065-001 Jun 12, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Perrigo Israel MESALAMINE mesalamine ENEMA;RECTAL 076751-001 Sep 17, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan MESALAMINE mesalamine CAPSULE, EXTENDED RELEASE;ORAL 207271-001 Nov 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Amring Pharms MESALAMINE mesalamine SUPPOSITORY;RECTAL 208362-001 Jun 21, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
G And W Labs Inc MESALAMINE mesalamine ENEMA;RECTAL 076841-001 Sep 30, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for mesalamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993   Start Trial   Start Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013   Start Trial   Start Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013   Start Trial   Start Trial
Shire PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993   Start Trial   Start Trial
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Medtronic
Mallinckrodt
Baxter
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.