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Salix Pharms Company Profile

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What is the competitive landscape for SALIX PHARMS, and what generic alternatives to SALIX PHARMS drugs are available?

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.

Summary for Salix Pharms

International Patents:	469
US Patents:	45
Tradenames:	10
Ingredients:	9
NDAs:	12

Drugs and US Patents for Salix Pharms

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	021964-003	Sep 27, 2010		RX	Yes	Yes	8,247,425
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes	8,853,231		Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	8,835,452		Y	Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes	8,946,252
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	022554-001	Mar 24, 2010		RX	Yes	Yes	8,642,573
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-002	Sep 4, 2009		DISCN	Yes	No

Expired US Patents for Salix Pharms

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
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-002	Sep 4, 2009	6,413,549
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987	4,283,408*PED
Salix Pharms	OSMOPREP	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate	TABLET;ORAL	021892-001	Mar 16, 2006	5,616,346
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008	6,559,158
Salix Pharms Inc	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016	6,559,158

Paragraph IV (Patent) Challenges for SALIX PHARMS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	8 mg/0.4 mL		2015-09-08
	Orally Disintegrating Tablets	5 mg and 10 mg		2010-08-24
	Tablets	550 mg		2015-12-18
	Injection	12 mg/0.6 mL		2015-07-22
	Tablets	150 mg		2016-09-06
	Tablets	1.102 g and 0.398 g		2008-04-09
	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

International Patents for Salix Pharms Drugs

Country	Document Number	Estimated Expiration
China	1767831
Israel	237377
Poland	216059
Spain	2522895
Croatia	P20150037
United Kingdom	201104200

Supplementary Protection Certificates for Salix Pharms Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0020	France		PRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
15/009	Ireland		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
14/058	Ireland		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
C0108	Belgium		PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522

Similar Applicant Names

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

• Salix Pharms
• Salix Pharms Inc