Pharsight

1. Amitiza patent expiration

Treatment: Method for relieving constipation in a human patient that comprises administering to the patient a dosage unit comprising (i) 24mcg+/- 10% of a drug substance and (ii) a pharmaceutically suitable exci...

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8097653	SUCAMPO	Dosage unit comprising a prostaglandin analog for treating constipation	Nov, 2022 (3 years ago)
US8071613	SUCAMPO	Anti-constipation composition	Sep, 2020 (5 years ago)
US8114890	SUCAMPO	Anti-constipation composition	Sep, 2020 (5 years ago)
US8389542	SUCAMPO	Dosage unit comprising a prostaglandin analog for treating constipation	Nov, 2022 (3 years ago)
US5284858	SUCAMPO	Prostaglandins E and anti ulcers containing same	Jul, 2014 (11 years ago)
US8088934	SUCAMPO	Composition and method for stabilizing the same	May, 2021 (4 years ago)
US7064148	SUCAMPO	Chloride channel opener	Aug, 2022 (3 years ago)
US6583174	SUCAMPO	Composition and method for stabilizing the same	Oct, 2020 (5 years ago)
US6414016	SUCAMPO	Anti-constipation composition	Sep, 2020 (5 years ago)
US7417067	SUCAMPO	Composition and method for stabilizing the same	Oct, 2020 (5 years ago)
US8097649	SUCAMPO	Composition and method for stabilizing the same	Oct, 2020 (5 years ago)
US6982283	SUCAMPO	Method for treating drug-induced constipation	Dec, 2022 (3 years ago)
US7795312	SUCAMPO	Method for treating abdominal discomfort	Sep, 2024 (1 year, 5 months ago)
US8748481	SUCAMPO	Method for treating gastrointestinal disorder	Sep, 2025 (5 months ago)
US8779187	SUCAMPO	Soft-gelatin capsule formulation	Jan, 2027 (10 months from now)
US8026393	SUCAMPO	Soft-gelatin capsule formulation	Oct, 2027 (1 year, 8 months from now)
US8338639	SUCAMPO	Soft-gelatin capsule formulation	Jan, 2027 (10 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-670)	Apr 19, 2016
M(M-225)	Apr 26, 2021

Drugs and Companies using LUBIPROSTONE ingredient

Market Authorisation Date: 29 April, 2008

Dosage: CAPSULE

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
8 mcg and 24 mcg	20 Aug, 2012	1	27 Jun, 2022	30 Aug, 2022	Extinguished

Strength	Dosage	Availability
24MCG	CAPSULE	Prescription
8MCG	CAPSULE	Prescription

AMITIZA family patents

2. Ibsrela patent expiration

Treatment: Method of treating irritable bowel syndrome with constipation by administering tenapanor

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8969377	ARDELYX	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders	Dec, 2029 (3 years from now)
US12016856	ARDELYX	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders	Dec, 2029 (3 years from now)
US8541448	ARDELYX	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders	Aug, 2033 (7 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9006281	ARDELYX	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders	May, 2030 (4 years from now)
US9408840	ARDELYX	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorder	Dec, 2029 (3 years from now)
US12539299	ARDELYX	NA	Nov, 2042 (16 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 12, 2024

Drugs and Companies using TENAPANOR HYDROCHLORIDE ingredient

NCE-1 date: 13 September, 2023

Market Authorisation Date: 12 September, 2019

Dosage: TABLET

Strength	Dosage	Availability
EQ 50MG BASE	TABLET	Prescription

IBSRELA family patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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3. Linzess patent expiration

Treatment: Method of treating of irritable bowel syndrome with constipation (ibs-c) in pediatric patients 7 years of age and older; Method of treating ...

Application	Filing Date	Opposition Party	Legal Status

EP12753313A	2017-09-14	Hexal AG	Revoked
EP10170038A	2013-03-26	Generics [UK] Limited	Opposition rejected

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7304036	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Aug, 2026 (6 months from now)
US7745409	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Jan, 2024 (2 years ago)
US7704947	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Jan, 2024 (2 years ago)
US8080526	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Jan, 2024 (2 years ago)
US7371727	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Jan, 2024 (2 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9708371	ABBVIE	Treatments for gastrointestinal disorders	Aug, 2033 (7 years from now)
US10702576 (Pediatric)	ABBVIE	Stable Formulations Of Linaclotide	Feb, 2032 (5 years from now)
US9708371 (Pediatric)	ABBVIE	Treatments For Gastrointestinal Disorders	Feb, 2034 (7 years from now)
US8110553	ABBVIE	Methods and compositions for the treatment of gastrointestinal disorders	Jan, 2024 (2 years ago)
US8933030	ABBVIE	Treatments for gastrointestinal disorders	Feb, 2031 (4 years from now)
US8748573	ABBVIE	Formulations comprising linaclotide	Oct, 2031 (5 years from now)
US10702576	ABBVIE	Stable formulations of linaclotide	Aug, 2031 (5 years from now)
US8748573 (Pediatric)	ABBVIE	Formulations Comprising Linaclotide	Apr, 2032 (6 years from now)
US7304036 (Pediatric)	ABBVIE	Methods And Compositions For The Treatment Of Gastrointestinal Disorders	Feb, 2027 (1 year, 6 days from now)
US8802628	ABBVIE	Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration	Oct, 2031 (5 years from now)
US10675325	ABBVIE	Stable formulations of linaclotide	Aug, 2031 (5 years from now)
US8933030 (Pediatric)	ABBVIE	Treatments For Gastrointestinal Disorders	Aug, 2031 (5 years from now)
US8802628 (Pediatric)	ABBVIE	Stable Solid Formulation Of A Gc-C Receptor Agonist Polypeptide Suitable For Oral Administration	Apr, 2032 (6 years from now)
US10675325 (Pediatric)	ABBVIE	Stable Formulations Of Linaclotide	Feb, 2032 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 30, 2017
New Strength(NS)	Jan 25, 2020
New Indication(I-921)	Jun 12, 2026
New Patient Population(NPP)	Nov 04, 2028
Pediatric Exclusivity(PED)	May 04, 2029

Drugs and Companies using LINACLOTIDE ingredient

NCE-1 date: 30 August, 2016

Market Authorisation Date: 25 January, 2017

Dosage: CAPSULE

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
145 mcg and 290 mcg	30 Aug, 2016	4	09 Feb, 2021	30 Oct, 2031	Deferred
72 mcg	07 Nov, 2017	1		16 Aug, 2033

Strength	Dosage	Availability
290MCG	CAPSULE	Prescription
72MCG	CAPSULE	Prescription
145MCG	CAPSULE	Prescription

LINZESS family patents

4. Lotronex patent expiration

Treatment: For women with severe diarrhea-predominant irritable bowel syndrome (ibs)

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5360800	LEGACY	Tetrahydro-1H-pyrido[4,3-b]indol-1-one derivatives	Jan, 2013 (13 years ago)
US6284770	LEGACY	Medicaments for the treatment of non-constipated female irritable bowel syndrome	Oct, 2018 (7 years ago)

Drugs and Companies using ALOSETRON HYDROCHLORIDE ingredient

Market Authorisation Date: 09 February, 2000

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.5 mg and 1 mg	02 Dec, 2010	1	04 May, 2015	05 Oct, 2018	Deferred

Strength	Dosage	Availability
EQ 1MG BASE	TABLET	Prescription
EQ 0.5MG BASE	TABLET	Prescription

LOTRONEX family patents

5. Viberzi patent expiration

Treatment: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with viberzi (eluxadoline).; Reduction of the frequency of abdominal pain and di...

Application	Filing Date	Opposition Party	Legal Status

EP14774006A	2019-05-28	Sandoz AG	Opposition rejected

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10213415	ABBVIE	Compounds as opioid receptor modulators	Mar, 2025 (11 months ago)
US9115091	ABBVIE	Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl—1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid	Jul, 2028 (2 years from now)
US8691860	ABBVIE	Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid	Jul, 2028 (2 years from now)
US8609709	ABBVIE	Compounds as opioid receptor modulators	Mar, 2025 (11 months ago)
US7786158	ABBVIE	Compounds as opioid receptor modulators	Mar, 2025 (11 months ago)
US7741356	ABBVIE	Compounds as opioid receptor modulators	May, 2029 (3 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8772325	ABBVIE	Compounds as opioid receptor modulators	Mar, 2025 (11 months ago)
US12097187	ABBVIE	Opioid receptor modulator dosage formulations	Mar, 2033 (7 years from now)
US9205076	ABBVIE	Compounds as opioid receptor modulators	Mar, 2025 (11 months ago)
US9364489	ABBVIE	Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid	Jul, 2028 (2 years from now)
US9789125	ABBVIE	Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid	Jul, 2028 (2 years from now)
US8344011	ABBVIE	Compounds as opioid receptor modulators	Mar, 2025 (11 months ago)
US9675587	ABBVIE	Opioid receptor modulator dosage formulations	Mar, 2033 (7 years from now)
US11007179	ABBVIE	Opioid receptor modulator dosage formulations	Mar, 2033 (7 years from now)
US11484527	ABBVIE	Opioid receptor modulator dosage formulations	Mar, 2033 (7 years from now)
US9700542	ABBVIE	Compounds as opioid receptor modulators	Mar, 2025 (11 months ago)
US11090291	ABBVIE	Opioid receptor modulator dosage formulations	Mar, 2033 (7 years from now)
US11311516	ABBVIE	Opioid receptor modulator dosage formulations	Mar, 2033 (7 years from now)
US11229627	ABBVIE	Opioid receptor modulator dosage formulations	Mar, 2033 (7 years from now)
US10188632	ABBVIE	Opioid receptor modulator dosage formulations	Mar, 2033 (7 years from now)
US11160792	ABBVIE	Opioid receptor modulator dosage formulations	Mar, 2033 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 27, 2020

Drugs and Companies using ELUXADOLINE ingredient

NCE-1 date: 28 May, 2019

Market Authorisation Date: 27 May, 2015

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
75 mg and 100 mg	28 May, 2019	6	14 Mar, 2025	14 Mar, 2033	Eligible

Strength	Dosage	Availability
75MG	TABLET	Prescription
100MG	TABLET	Prescription

VIBERZI family patents

6. Xifaxan patent expiration

Treatment: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults 65 years of age or older; Reduction in a subject's risk of experiencin...

Application	Filing Date	Opposition Party	Legal Status

EP09818544A	2020-09-11	Alfred E. Tiefenbacher (GmbH & Co. KG)	Granted and Under Opposition
EP09818544A	2020-09-11	Hollatz, Christian	Granted and Under Opposition
EP09818544A	2020-09-11	STADA Arzneimittel AG	Granted and Under Opposition
EP09818544A	2020-09-09	Accord Healthcare Ltd	Granted and Under Opposition
EP09818544A	2020-09-09	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP09818544A	2020-09-07	Aera A/S	Granted and Under Opposition
EP09818544A	2020-08-31	Lederer & Keller Patentanwälte Partnerschaft mbB	Granted and Under Opposition
EP09818544A	2020-08-06	CMS Cameron McKenna Nabarro Olswang LLP	Granted and Under Opposition
EP09715020A	2019-12-19	Lederer & Keller Patentanwälte Partnerschaft mbB	Granted and Under Opposition
EP09715020A	2019-12-19	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP09715020A	2019-12-18	Sandoz GmbH	Granted and Under Opposition
EP05004695A	2015-06-03	Sandoz GmbH	Revoked
EP04005541A	2008-02-08	Interquim, S.A. De C.V.	Opposition rejected

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8741904	SALIX	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations	Feb, 2026 (5 days from now)
US8835452	SALIX	Polymorphic forms α, β and γ of rifaximin	Jun, 2024 (1 year, 8 months ago)
US8193196	SALIX	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations	Sep, 2027 (1 year, 6 months from now)
US8158781	SALIX	Polymorphic forms α, β and γ of rifaximin	Jun, 2024 (1 year, 8 months ago)
US7612199	SALIX	Polymorphic forms α, β, and γ of rifaximin	Jun, 2024 (1 year, 8 months ago)
US7902206	SALIX	Polymorphic forms α, β and γ of rifaximin	Jun, 2024 (1 year, 8 months ago)
US7045620	SALIX	Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations	Jun, 2024 (1 year, 8 months ago)
US7906542	SALIX	Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin	Jun, 2025 (8 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10456384	SALIX	Methods for treating irritable bowel syndrome (IBS)	Feb, 2029 (3 years from now)
US10335397	SALIX	Methods of treating hepatic encephalopathy	Jul, 2029 (3 years from now)
US9421195	SALIX	Methods of treating hepatic encephalopathy	Jul, 2029 (3 years from now)
US8946252	SALIX	Methods of treating traveler's diarrhea and hepatic encephalopathy	Jul, 2029 (3 years from now)
US7452857	SALIX	Methods of treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth	Aug, 2019 (6 years ago)
US8829017	SALIX	Methods of treating traveler's diarrhea and hepatic encephalopathy	Jul, 2029 (3 years from now)
US8642573	SALIX	Methods of treating hepatic encephalopathy	Oct, 2029 (3 years from now)
US10314828	SALIX	Methods of treating hepatic encephalopathy	Jul, 2029 (3 years from now)
US7915275	SALIX	Use of polymorphic forms of rifaximin for medical preparations	Feb, 2025 (11 months ago)
US7605240	SALIX	Methods of treating diarrhea and bloating caused by small intestinal bacterial overgrowth	Aug, 2019 (6 years ago)
US7935799	SALIX	Methods of treating diarrhea caused by small intestinal bacterial overgrowth	Aug, 2019 (6 years ago)
US10709694	SALIX	Methods of treating hepatic encephalopathy	Jul, 2029 (3 years from now)
US10765667	SALIX	Methods for treating irritable bowel syndrome (IBS)	Feb, 2029 (3 years from now)
US8969398	SALIX	Methods of treating hepatic encephalopathy	Oct, 2029 (3 years from now)
US6861053	SALIX	Methods of diagnosing or treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth	Aug, 2019 (6 years ago)
US8518949	SALIX	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations	Feb, 2026 (5 days from now)
US9629828	SALIX	Methods of treating traveler's diarrhea and hepatic encephalopathy	Jul, 2029 (3 years from now)
US9271968	SALIX	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations	Feb, 2026 (5 days from now)
US8158781	SALIX	Polymorphic forms α, β and γ of rifaximin	Jun, 2024 (1 year, 8 months ago)
US8158644	SALIX	Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin	Jun, 2024 (1 year, 8 months ago)
US7612199	SALIX	Polymorphic forms α, β, and γ of rifaximin	Jun, 2024 (1 year, 8 months ago)
US8853231	SALIX	Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin	Jun, 2024 (1 year, 8 months ago)
US7045620	SALIX	Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations	Jun, 2024 (1 year, 8 months ago)
US8193196	SALIX	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations	Sep, 2027 (1 year, 6 months from now)
US10703763	SALIX	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations	Feb, 2026 (5 days from now)
US7718608	SALIX	Methods of treating a subject suffering from irritable bowel syndrome	Aug, 2019 (6 years ago)
US8309569	SALIX	Methods for treating diarrhea-associated irritable bowel syndrome	Jul, 2029 (3 years from now)
US7902206	SALIX	Polymorphic forms α, β and γ of rifaximin	Jun, 2024 (1 year, 8 months ago)
US7906542	SALIX	Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin	Jun, 2025 (8 months ago)
US11564912	SALIX	Methods for treating irritable bowel syndrome (IBS)	Feb, 2029 (3 years from now)
US7928115	SALIX	Methods of treating travelers diarrhea and hepatic encephalopathy	Jul, 2029 (3 years from now)
US11779571	SALIX	Methods for treating irritable bowel syndrome (IBS)	Feb, 2029 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Mar 24, 2013
Orphan Drug Exclusivity(ODE)	Mar 24, 2017
New Indication(I-709)	May 27, 2018

Drugs and Companies using RIFAXIMIN ingredient

Market Authorisation Date: 24 March, 2010

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
550 mg	18 Dec, 2015	1		02 Oct, 2029	Non-Forfeiture Non-Forfeiture
200 mg	28 Jan, 2019	1		24 Jul, 2029

Strength	Dosage	Availability
550MG	TABLET	Prescription
200MG	TABLET	Prescription

XIFAXAN family patents

7. Zelnorm patent expiration

Treatment: Treatment of irritable bowel syndrome

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5510353	ALFASIGMA	Certain aminoguanidine compounds, pharmaceutical compositions containing them and their use in treating gastrointestinal motility disorders and disorders associated with cephalic pain	Apr, 2013 (12 years ago)

Drugs and Companies using TEGASEROD MALEATE ingredient

Market Authorisation Date: 24 July, 2002

Dosage: TABLET

Pharsight

Pharsight

Irritable Bowel Syndrome Therapeutics

1. Amitiza patent expiration

AMITIZA family patents

2. Ibsrela patent expiration

IBSRELA family patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

3. Linzess patent expiration

LINZESS family patents

4. Lotronex patent expiration

LOTRONEX family patents

5. Viberzi patent expiration

VIBERZI family patents

6. Xifaxan patent expiration

XIFAXAN family patents

7. Zelnorm patent expiration

ZELNORM family patents

Have Questions?

Pharsight

Pharsight

Irritable Bowel Syndrome Therapeutics

1. Amitiza patent expiration

AMITIZA family patents

2. Ibsrela patent expiration

IBSRELA family patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years. Get the exclusive patent insights now. Don't be the last to know. Download Report 3. Linzess patent expiration

LINZESS family patents

4. Lotronex patent expiration

LOTRONEX family patents

5. Viberzi patent expiration

VIBERZI family patents

6. Xifaxan patent expiration

XIFAXAN family patents

7. Zelnorm patent expiration

ZELNORM family patents

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Have Questions?

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

3. Linzess patent expiration