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Salix Pharms Company Profile

SALIX PHARMS has twelve approved drugs.

There are forty-five US patents protecting SALIX PHARMS drugs.

There are four hundred and sixty-nine patent family members on SALIX PHARMS drugs in fifty-three countries and forty-eight supplementary protection certificates in nine countries.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix Pharms Inc	PLENVU	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	209381-001	May 4, 2018		RX	Yes	Yes	9,592,252	➤ Sign Up	Y			➤ Sign Up
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	7,045,620	➤ Sign Up	Y	Y		➤ Sign Up
Salix Pharms	OSMOPREP	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021892-001	Mar 16, 2006		RX	Yes	Yes	7,687,075	➤ Sign Up	Y	Y		➤ Sign Up
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes	9,421,195	➤ Sign Up				➤ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010		RX	Yes	Yes	9,492,445	➤ Sign Up	Y			➤ Sign Up
Salix Pharms Inc	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016		RX	Yes	Yes	8,420,663	➤ Sign Up				➤ Sign Up
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes	7,935,799	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	VISICOL	sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021097-001	Sep 21, 2000	5,616,346	➤ Sign Up
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-001	Sep 4, 2009	6,413,549	➤ Sign Up
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-002	Sep 4, 2009	6,413,549	➤ Sign Up
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987	4,283,408*PED	➤ Sign Up
Salix Pharms	OSMOPREP	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021892-001	Mar 16, 2006	5,616,346	➤ Sign Up
Salix Pharms Inc	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016	6,559,158	➤ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008	6,559,158	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	150 mg	➤ Subscribe	2016-09-06
➤ Subscribe	Tablets	1.102 g and 0.398 g	➤ Subscribe	2008-04-09
➤ Subscribe	For Oral Solution	140 g, 5.2 g, 2.2.g, 48.11 g, 9g and 7.54 g per pouch	➤ Subscribe	2018-12-06
➤ Subscribe	For Oral Solution	100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch	➤ Subscribe	2007-11-27
➤ Subscribe	Injection	8 mg/0.4 mL	➤ Subscribe	2015-09-08
➤ Subscribe	Orally Disintegrating Tablets	5 mg and 10 mg	➤ Subscribe	2010-08-24
➤ Subscribe	Tablets	550 mg	➤ Subscribe	2015-12-18
➤ Subscribe	Injection	12 mg/0.6 mL	➤ Subscribe	2015-07-22

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Country	Document Number	Estimated Expiration
Chile	2004000498	➤ Sign Up
Russian Federation	2014104362	➤ Sign Up
Japan	2013216710	➤ Sign Up
Eurasian Patent Organization	027526	➤ Sign Up
Portugal	1676847	➤ Sign Up
Japan	2012025732	➤ Sign Up
Canada	2460384	➤ Sign Up
Country	Document Number	Estimated Expiration

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0022	France	➤ Sign Up	PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
C0076	France	➤ Sign Up	PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140514
C0108	Belgium	➤ Sign Up	PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
2015 00014	Denmark	➤ Sign Up	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
C/GB10/012	United Kingdom	➤ Sign Up	PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
C/GB06/021	United Kingdom	➤ Sign Up	PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
C0052	France	➤ Sign Up	PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

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