Salix Company Profile

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SALIX has eighteen approved drugs.

There are seventy-six US patents protecting SALIX drugs.

There are six hundred and fifty-six patent family members on SALIX drugs in fifty-five countries and ninety-seven supplementary protection certificates in twelve countries.

International Patents:	656
US Patents:	76
Tradenames:	15
Ingredients:	13
NDAs:	18
Patent Litigation for Salix:	See patent lawsuits for Salix
PTAB Cases with Salix as patent owner:	See PTAB cases with Salix as patent owner

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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	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	AP	RX	Yes	Yes	9,669,096	⤷ Subscribe	Y			⤷ Subscribe
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	AP	RX	Yes	Yes	8,247,425	⤷ Subscribe				⤷ Subscribe
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	10,456,384	⤷ Subscribe				⤷ Subscribe
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	8,946,252	⤷ Subscribe				⤷ Subscribe
Salix	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	10,646,512	⤷ Subscribe	Y			⤷ Subscribe
>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	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	6,699,885	⤷ Subscribe
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	6,489,346	⤷ Subscribe
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	8,956,647	⤷ Subscribe
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	8,124,125	⤷ Subscribe
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	8,552,025	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	1.102 g and 0.398 g	➤ Subscribe	2008-04-09
➤ Subscribe	Tablets	200 mg	➤ Subscribe	2019-01-28
➤ Subscribe	Extended-release Capsules	0.375 g	➤ Subscribe	2012-04-03
➤ Subscribe	Powder for Oral Suspension	40 mg/1680 mg per packet	➤ Subscribe	2007-08-24
➤ 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	Injection	12 mg/0.6 mL	➤ Subscribe	2015-07-22
➤ Subscribe	Tablets	150 mg	➤ Subscribe	2016-09-06
➤ Subscribe	Orally Disintegrating Tablets	5 mg and 10 mg	➤ Subscribe	2010-08-24
➤ Subscribe	Tablets	550 mg	➤ Subscribe	2015-12-18
➤ Subscribe	Extended-release Tablets	9 mg	➤ Subscribe	2013-03-11
➤ Subscribe	Capsules	20 mg/1100 mg and 40 mg/1100 mg	➤ Subscribe	2007-04-30
➤ Subscribe	Powder for Oral Suspension	20mg/1680mg per packet	➤ Subscribe	2007-11-13
➤ Subscribe	Tablets	40 mg and 120 mg	➤ Subscribe	2010-03-17
➤ Subscribe	Injection	8 mg/0.4 mL	➤ Subscribe	2015-09-08
➤ 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

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010040113	⤷ Subscribe
Poland	2350096	⤷ Subscribe
Serbia	54569	⤷ Subscribe
Lithuania	2314319	⤷ Subscribe
European Patent Office	1567193	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	18C1043	France	⤷ Subscribe	PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
2673237	LUC00111	Luxembourg	⤷ Subscribe	PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326
0186405	SPC/GB00/021	United Kingdom	⤷ Subscribe	PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
1758590	2017C/063	Belgium	⤷ Subscribe	PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
0502314	C300095	Netherlands	⤷ Subscribe	PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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