SALIX Company Profile

What is the competitive landscape for SALIX, and when can generic versions of SALIX drugs launch?

SALIX has eighteen approved drugs.

There are seventy-five US patents protecting SALIX drugs.

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

Summary for SALIX

International Patents:	649
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

Drugs and US Patents for SALIX

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	10,703,763
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	7,045,620			Y
Salix	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016		RX	Yes	Yes	9,314,461		Y
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	7,658,914		Y	Y
Salix	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016		RX	Yes	Yes	10,307,417		Y
Salix Pharms	OSMOPREP	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021892-001	Mar 16, 2006		DISCN	Yes	No	7,687,075		Y	Y

Expired US Patents for SALIX

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
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	8,911,778
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	RE45198
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	9,532,954
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	7,399,772
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006	7,399,772

Paragraph IV (Patent) Challenges for SALIX drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Orally Disintegrating Tablets	5 mg and 10 mg		2010-08-24
	Tablets	550 mg		2015-12-18
	Extended-release Tablets	9 mg		2013-03-11
	Capsules	20 mg/1100 mg and 40 mg/1100 mg		2007-04-30
	Powder for Oral Suspension	20mg/1680mg per packet		2007-11-13
	Tablets	40 mg and 120 mg		2010-03-17
	Injection	8 mg/0.4 mL		2015-09-08
	For Oral Solution	100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch		2007-11-27
	Tablets	1.102 g and 0.398 g		2008-04-09
	Tablets	200 mg		2019-01-28
	Extended-release Capsules	0.375 g		2012-04-03
	Powder for Oral Suspension	40 mg/1680 mg per packet		2007-08-24
	For Oral Solution	140 g, 5.2 g, 2.2.g, 48.11 g, 9g and 7.54 g per pouch		2018-12-06
	Injection	12 mg/0.6 mL		2015-07-22
	Tablets	150 mg		2016-09-06

International Patents for SALIX Drugs

Country	Patent Number	Estimated Expiration
Russian Federation	2007136430
Austria	251449
Japan	2014507462
United Kingdom	0224909
Russian Federation	2600790
Japan	2003501457

Supplementary Protection Certificates for SALIX Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0480717	SPC/GB98/025	United Kingdom		PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
3141251	132021000000044	Italy		PRODUCT NAME: UN PRODOTTO MEDICINALE COSTITUITO DA UNA COMBINAZIONE DI UNA PRIMA DOSE DI COMPOSIZIONE FARMACEUTICA E UNA SECONDA DOSE DI COMPOSIZIONE FARMACEUTICA, LA PRIMA DOSE DI COMPOSIZIONE FARMACEUTICA E COSTITUITA DAGLI INGREDIENTI ATTIVI POLIETILENGLICOLE, SOLFATO DI SODIO, CLORURO DI SODIO E CLORURO DI POTASSIO E LA SECONDA DOSE DI COMPOSIZIONE FARMACEUTICA E COSTITUITA DAGLI INGREDIENTI ATTIVI POLIETILENGLICOLE, ACIDO ASCORBICO, ASCORBATO DI SODIO, CLORURO DI SODIO E CLORURO DI POTASSIO.(PLENVU); AUTHORISATION NUMBER(S) AND DATE(S): IS/1/17/083/01, 20171016;045671017, 045671029, 045671031, 045671043, 045671056, 20171213
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
3141251	C202130017	Spain		PRODUCT NAME: COMBINACION DE PRINCIPIOS ACTIVOS EN DOS DOSIS, EN LA QUE LA PRIMERA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, SULFATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO, Y LA SEGUNDA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, ACIDO ASCORBICO, ASCORBATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO.; NATIONAL AUTHORISATION NUMBER: 82959-SE/H/1801/001/DC; DATE OF AUTHORISATION: 20180525; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): IS/1/17/083/01; DATE OF FIRST AUTHORISATION IN EEA: 20171016

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Salix
• Salix Pharms