SALIX Company Profile

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SALIX has eighteen approved drugs.

There are seventy-five US patents protecting SALIX drugs.

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

International Patents:	648
US Patents:	75
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	MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881-001	Aug 2, 2006	AA	RX	Yes	Yes	7,169,381	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	7,915,275	⤷ Try a Trial				⤷ Try a Trial
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010		RX	Yes	Yes	9,492,445	⤷ Try a Trial	Y			⤷ Try a Trial
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	10,314,828	⤷ Try a Trial				⤷ Try a Trial
>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	CAPSULE;ORAL	021849-002	Feb 27, 2006	6,645,988	⤷ Try a Trial
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	8,911,778	⤷ Try a Trial
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	RE45198	⤷ Try a Trial
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	9,532,954	⤷ Try a Trial
>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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Country	Patent Number	Estimated Expiration
Australia	2018286626	⤷ Try a Trial
Eurasian Patent Organization	201500320	⤷ Try a Trial
Malaysia	193378	⤷ Try a Trial
Portugal	2252148	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0957929	SPC/GB06/021	United Kingdom	⤷ Try a Trial	PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
2563920	CA 2019 00001	Denmark	⤷ Try a Trial	PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710
1948158	93075	Luxembourg	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN, C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3'-METHYL-2-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
2932970	SPC/GB18/041	United Kingdom	⤷ Try a Trial	PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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