Pharsight

1. Metozolv Odt patents expiration

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).
US6413549	SALIX PHARMS	Fast-Dispersing solid oral dosage form containing coarse particles	Jul, 2017 (6 years ago)

Drugs and Companies using METOCLOPRAMIDE HYDROCHLORIDE ingredient

Market Authorisation Date: 04 September, 2009

Treatment: NA

Dosage: TABLET, ORALLY DISINTEGRATING;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg and 10 mg	24 Aug, 2010	1	15 Aug, 2014	11 Jul, 2017	Extinguished Deferred

Strength	Dosage	Availability
EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued

METOZOLV ODT family patents

2. Moviprep patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP03758361A	2009-05-12	Teva Pharmaceutical Industries LTD.	Opposition procedure closed

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.
US7658914	SALIX PHARMS	Colon cleansing compositions	Sep, 2024 (4 months from now)
US7169381	SALIX PHARMS	Colon cleansing compositions and methods	Sep, 2024 (4 months from now)

Drugs and Companies using ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE ingredient

Market Authorisation Date: 02 August, 2006

Treatment: NA

Dosage: FOR SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch	27 Nov, 2007	1	25 Jan, 2012	01 Sep, 2024	Eligible

Strength	Dosage	Availability
4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION;ORAL	Prescription

MOVIPREP family patents

3. Osmoprep patents expiration

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.
US7687075	SALIX PHARMS	Colonic purgative composition with soluble binding agent	Jun, 2028 (4 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).
US5616346	SALIX PHARMS	Non-aqueous colonic purgative formulations	May, 2013 (10 years ago)

Drugs and Companies using SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE ingredient

Market Authorisation Date: 16 March, 2006

Treatment: For cleansing the bowel in preparation for colonoscopy, in adults 18 years of age or older

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
1.102 g and 0.398 g	09 Apr, 2008	1	30 Dec, 2011	18 May, 2013	Eligible

Strength	Dosage	Availability
0.398GM;1.102GM	TABLET;ORAL	Discontinued

OSMOPREP family patents

4. Relistor patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP10184575A	2015-09-30	Actavis Group PTC ehf	Revoked
EP10184575A	2015-09-29	Fresenius Kabi Deutschland GmbH	Revoked
EP04759349A	2015-09-24	Actavis Group PTC ehf	Patent maintained as amended
EP04759349A	2015-09-24	Fresenius Kabi Deutschland GmbH	Patent maintained as amended
EP10184684A	2015-09-24	Fresenius Kabi Deutschland GmbH	Revoked
EP10184684A	2015-09-24	Actavis Group PTC ehf	Revoked

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).
US6559158	SALIX PHARMS	Use of methylnaltrexone and related compounds to treat chronic opioid use side affects	Nov, 2017 (6 years ago)
US9669096	SALIX PHARMS	Stable pharmaceutical formulations of methylnaltrexone	Apr, 2024 (15 days ago)
US8552025	SALIX PHARMS	Stable methylnaltrexone preparation	Apr, 2024 (15 days ago)
US10376584	SALIX PHARMS	Stable pharmaceutical formulations of methylnaltrexone	Apr, 2024 (15 days ago)
US9492445	SALIX PHARMS	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US8822490	SALIX PHARMS	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US9180125	SALIX PHARMS	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US8420663	SALIX PHARMS	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US8247425	SALIX PHARMS	Peripheral opioid receptor antagonists and uses thereof	Dec, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 24, 2013

Drugs and Companies using METHYLNALTREXONE BROMIDE ingredient

NCE-1 date: 24 April, 2012

Market Authorisation Date: 27 September, 2010

Treatment: Treatment of opioid-induced constipation

Dosage: SOLUTION;SUBCUTANEOUS

Strength	Submission Date	ANDA(s) Filed	Last patent expiry
12 mg/0.6 mL	22 Jul, 2015	1	31 Dec, 2030
8 mg/0.4 mL	08 Sep, 2015	1	31 Dec, 2030
150 mg	06 Sep, 2016	1	10 Mar, 2031

Strength	Dosage	Availability
8MG/0.4ML (8MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription
12MG/0.6ML (12MG/0.6ML)	SOLUTION;SUBCUTANEOUS	Prescription

RELISTOR family patents

5. Visicol patents expiration

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).
US5616346	SALIX PHARMS	Non-aqueous colonic purgative formulations	May, 2013 (10 years ago)

Drugs and Companies using SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE ingredient

Market Authorisation Date: 21 September, 2000

Treatment: Method of use of visicol

Dosage: TABLET;ORAL

Strength	Dosage	Availability
0.398GM;1.102GM	TABLET;ORAL	Discontinued

VISICOL family patents

6. Xifaxan patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP09818544A	2020-09-11	STADA Arzneimittel AG	Granted and Under Opposition
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	2020-09-09	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP09818544A	2020-09-09	Accord Healthcare 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.
US8158781	SALIX PHARMS	Polymorphic forms α, β and γ of rifaximin	Jun, 2024 (a month from now)
US7902206	SALIX PHARMS	Polymorphic forms α, β and γ of rifaximin	Jun, 2024 (a month from now)
US7045620	SALIX PHARMS	Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations	Jun, 2024 (a month from now)
US7612199	SALIX PHARMS	Polymorphic forms α, β, and γ of rifaximin	Jun, 2024 (a month from now)
US8835452	SALIX PHARMS	Polymorphic forms α, β and γ of rifaximin	Jun, 2024 (a month from now)
US7906542	SALIX PHARMS	Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin	Jun, 2025 (1 year, 1 month from now)
US8741904	SALIX PHARMS	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations	Feb, 2026 (1 year, 10 months from now)
US8193196	SALIX PHARMS	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations	Sep, 2027 (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).
US7605240	SALIX PHARMS	Methods of treating diarrhea and bloating caused by small intestinal bacterial overgrowth	Aug, 2019 (4 years ago)
US7935799	SALIX PHARMS	Methods of treating diarrhea caused by small intestinal bacterial overgrowth	Aug, 2019 (4 years ago)
US7718608	SALIX PHARMS	Methods of treating a subject suffering from irritable bowel syndrome	Aug, 2019 (4 years ago)
US7452857	SALIX PHARMS	Methods of treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth	Aug, 2019 (4 years ago)
US6861053	SALIX PHARMS	Methods of diagnosing or treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth	Aug, 2019 (4 years ago)
US8158644	SALIX PHARMS	Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin	Jun, 2024 (a month from now)
US8853231	SALIX PHARMS	Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin	Jun, 2024 (a month from now)
US7915275	SALIX PHARMS	Use of polymorphic forms of rifaximin for medical preparations	Feb, 2025 (10 months from now)
US10703763	SALIX PHARMS	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations	Feb, 2026 (1 year, 10 months from now)
US9271968	SALIX PHARMS	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations	Feb, 2026 (1 year, 10 months from now)
US8518949	SALIX PHARMS	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations	Feb, 2026 (1 year, 10 months from now)
US11564912	SALIX PHARMS	Methods for treating irritable bowel syndrome (IBS)	Feb, 2029 (4 years from now)
US10456384	SALIX PHARMS	Methods for treating irritable bowel syndrome (IBS)	Feb, 2029 (4 years from now)
US10765667	SALIX PHARMS	Methods for treating irritable bowel syndrome (IBS)	Feb, 2029 (4 years from now)
US11779571	SALIX PHARMS	Methods for treating irritable bowel syndrome (IBS)	Feb, 2029 (4 years from now)
US8309569	SALIX PHARMS	Methods for treating diarrhea-associated irritable bowel syndrome	Jul, 2029 (5 years from now)
US10709694	SALIX PHARMS	Methods of treating hepatic encephalopathy	Jul, 2029 (5 years from now)
US9421195	SALIX PHARMS	Methods of treating hepatic encephalopathy	Jul, 2029 (5 years from now)
US9629828	SALIX PHARMS	Methods of treating traveler's diarrhea and hepatic encephalopathy	Jul, 2029 (5 years from now)
US8829017	SALIX PHARMS	Methods of treating traveler's diarrhea and hepatic encephalopathy	Jul, 2029 (5 years from now)
US8946252	SALIX PHARMS	Methods of treating traveler's diarrhea and hepatic encephalopathy	Jul, 2029 (5 years from now)
US10335397	SALIX PHARMS	Methods of treating hepatic encephalopathy	Jul, 2029 (5 years from now)
US7928115	SALIX PHARMS	Methods of treating travelers diarrhea and hepatic encephalopathy	Jul, 2029 (5 years from now)
US10314828	SALIX PHARMS	Methods of treating hepatic encephalopathy	Oct, 2029 (5 years from now)
US8642573	SALIX PHARMS	Methods of treating hepatic encephalopathy	Oct, 2029 (5 years from now)
US8969398	SALIX PHARMS	Methods of treating hepatic encephalopathy	Oct, 2029 (5 years from now)

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

Drugs and Companies using RIFAXIMIN ingredient

Market Authorisation Date: 24 March, 2010

Treatment: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.; Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.; Reduction in risk of overt hepatic ...

Dosage: TABLET;ORAL

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
200 mg	28 Jan, 2019	1		24 Jul, 2029

Pharsight

Salix Pharms patents expiration

1. Metozolv Odt patents expiration

METOZOLV ODT family patents

2. Moviprep patents expiration

MOVIPREP family patents

3. Osmoprep patents expiration

OSMOPREP family patents

4. Relistor patents expiration

RELISTOR family patents

5. Visicol patents expiration

VISICOL family patents

6. Xifaxan patents expiration

XIFAXAN family patents

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