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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Covington
Express Scripts
Chubb
Cantor Fitzgerald
Baxter
QuintilesIMS
Cipla
Novartis
Medtronic

Generated: October 21, 2017

DrugPatentWatch Database Preview

Salix Pharms Company Profile

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

SALIX PHARMS has eleven approved drugs.

There are forty-two US patents protecting SALIX PHARMS drugs and there have been four Paragraph IV challenges on SALIX PHARMS drugs in the past three years.

There are three hundred and ninety-eight patent family members on SALIX PHARMS drugs in forty-six countries and forty-six supplementary protection certificates in nine countries.

Summary for Applicant: Salix Pharms

International Patents:398
US Patents:42
Tradenames:9
Ingredients:9
NDAs:11
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix Pharms
VISICOL
sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL021097-001Sep 21, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe
Salix Pharms Inc
RELISTOR
methylnaltrexone bromide
TABLET;ORAL208271-001Jul 19, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Salix Pharms Inc
RELISTOR
methylnaltrexone bromide
TABLET;ORAL208271-001Jul 19, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-002Sep 4, 2009DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL021361-001May 25, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Salix Pharms
MOVIPREP
ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate
FOR SOLUTION;ORAL021881-001Aug 2, 2006RXYesYes► Subscribe► SubscribeYY ► Subscribe
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-001Sep 4, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Salix Pharms
RELISTOR
methylnaltrexone bromide
SOLUTION;SUBCUTANEOUS021964-003Sep 27, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Salix Pharms
RELISTOR
methylnaltrexone bromide
SOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired 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;ORAL021097-001Sep 21, 2000► Subscribe► Subscribe
Salix Pharms
PEPCID
famotidine
FOR SUSPENSION;ORAL019527-001Feb 2, 1987► Subscribe► Subscribe
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-002Sep 4, 2009► Subscribe► Subscribe
Salix Pharms
OSMOPREP
sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL021892-001Mar 16, 2006► Subscribe► Subscribe
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-001Sep 4, 2009► Subscribe► Subscribe
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Paragraph IV activity for SALIX PHARMS drugs

Drugname Dosage Strength Tradename Submissiondate
methylnaltrexone bromide
Tablets150 mg
RELISTOR
9/6/2016
rifaximin
Tablets550 mg
XIFAXAN
12/18/2015
methylnaltrexone bromide
Injection8 mg/0.4 mL
RELISTOR
9/8/2015
methylnaltrexone bromide
Injection12 mg/0.6 mL
RELISTOR
7/22/2015
metoclopramide hydrochloride
Orally Disintegrating Tablets5 mg and 10 mg
METOZOLV ODT
8/24/2010
sodium phosphate monobasic monohydrate and sodium phosphatedibasic anhydrous, usp
Tablets1.102 g and 0.398 g
OSMOPREP
4/9/2008
polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and
For Oral Solution100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch
MOVIPREP
11/27/2007

Non-Orange Book Patents for Salix Pharms

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,977,175 Methods and compositions for improving digestion and absorption in the small intestine► Subscribe
9,566,270Methods for treating irritable bowel syndrome (IBS)► Subscribe
8,110,177Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions► Subscribe
7,615,207Methods for treating irritable bowel syndrome► Subscribe
7,585,838Methods of treating fibromyalgia caused by small intestinal bacterial overgrowth► Subscribe
8,388,935Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions► Subscribe
5,976,577 Process for preparing fast dispersing solid oral dosage form► Subscribe
6,805,852 Methods of diagnosing irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth► Subscribe
8,173,801Processes for the production of polymorphic forms of rifaximin► Subscribe
8,455,644Peripheral opioid receptor antagonists and uses thereof► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Salix Pharms Drugs

Country Document Number Estimated Expiration
Israel212055► Subscribe
European Patent Office2210893► Subscribe
Russian Federation2007136430► Subscribe
European Patent Office1557421► Subscribe
Portugal2256498► Subscribe
World Intellectual Property Organization (WIPO)2006094662► Subscribe
Germany60322940► Subscribe
World Intellectual Property Organization (WIPO)2009108814► Subscribe
SloveniaEP1698630► Subscribe
South Korea20120045015► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Salix Pharms Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90064-1Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
90020-1Sweden► SubscribePRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
C/GB08/036United Kingdom► SubscribePRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
C/GB02/042United Kingdom► SubscribePRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020418
90062-5Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
90018-6Sweden► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
C0052France► SubscribePRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
C0076France► SubscribePRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140514
C/GB97/078United Kingdom► SubscribePRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
C0020France► SubscribePRODUCT 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
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Citi
Cerilliant
Farmers Insurance
Boehringer Ingelheim
Fish and Richardson
Moodys
QuintilesIMS
US Army
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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