linaclotide Oral Capsule

Brand(s)
Linzess
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Forest Laboratories, Inc (2014-07-08)
Oldest Current Product
2012-08-30
License(s)
NDA
RxNORM
ORAL CAPSULE\LINACLOTIDE
FDAOB
ORAL\CAPSULE\LINACLOTIDE
SPL Active
ORAL\CAPSULE, GELATIN COATED\LINACLOTIDE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\LINACLOTIDE

product(s) by strength(s)

linaclotide 0.145 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004561201LinzessNDAForest Laboratories, Inc2012-08-30LINACLOTIDEORALCAPSULE, GELATIN COATEDNDA20281109beda19-56d6-4a56-afdc-9a77b70b2ef3

linaclotide 0.29 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004561202LinzessNDAForest Laboratories, Inc2012-08-30LINACLOTIDEORALCAPSULE, GELATIN COATEDNDA20281109beda19-56d6-4a56-afdc-9a77b70b2ef3

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202811LINZESSFOREST LABORATORIES LLC2012-08-30p7745409, SUBSTANCE
p8933030, SUBSTANCE
p8802628, SUBSTANCE
p8748573, METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULT PATIENTS./ METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
p7304036, METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS, SUBSTANCE
p8080526, SUBSTANCE
p7704947, SUBSTANCE
p7371727
p8110553, METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS
NEW CHEMICAL ENTITY [2017-08-30]NDA202811_001, NDA202811_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202811_001RXLINACLOTIDE (145MCG)ORALCAPSULEFalse2012-08-30LINZESS
2NDA202811_002RXLINACLOTIDE (290MCG)ORALCAPSULETrue2012-08-30LINZESS

patent(s)

#idexpiration dateapplication(s)
1p7304036 (view patent)2024-01-28NDA202811
2p7371727 (view patent)2024-01-28NDA202811
3p7704947 (view patent)2024-01-28NDA202811
4p7745409 (view patent)2024-01-28NDA202811
5p8080526 (view patent)2024-01-28NDA202811
6p8110553 (view patent)2024-01-28NDA202811
7p8748573 (view patent)2031-06-20NDA202811
8p8802628 (view patent)2031-07-24NDA202811
9p8933030 (view patent)2031-02-17NDA202811

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
109beda19-56d6-4a56-afdc-9a77b70b2ef3 (view SPL)These highlights do not include all the information needed to use LINZESS safely and effectively. See full prescribing information for LINZESS.LINZESS (linaclotide) capsules, for oral useInitial U.S. Approval: 2012prescriptionHuman PrescriptionForest Laboratories, IncPACK2014-07-087004561201, 004561202

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII