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	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	8,835,452	⤷ Sign Up	Y	Y		⤷ Sign Up
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	12,083,179	⤷ Sign Up	Y			⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	AP	RX	Yes	Yes	9,492,445	⤷ Sign Up	Y			⤷ Sign Up
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	8,158,781	⤷ Sign Up		Y		⤷ Sign Up
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	8,158,781	⤷ Sign Up		Y		⤷ Sign Up
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987		DISCN	Yes	No		⤷ 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	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	RE43799	⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	8,552,025	⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008	6,559,158	⤷ Sign Up
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	5,840,737	⤷ Sign Up
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	7,902,206	⤷ Sign Up
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006	6,645,988	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0268956	1999C0030	Belgium	⤷ Sign Up	PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
2340828	LUC00195	Luxembourg	⤷ Sign Up	PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0579826	02C0041	France	⤷ Sign Up	PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
2666774	CR 2020 00037	Denmark	⤷ Sign Up	PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
2203431	1590018-6	Sweden	⤷ Sign Up	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
1666481	17C1031	France	⤷ Sign Up	PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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