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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Mallinckrodt
AstraZeneca
Federal Trade Commission
Chinese Patent Office
Cantor Fitzgerald
Chubb
Farmers Insurance
Fish and Richardson

Generated: December 16, 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-three patent family members on SALIX PHARMS drugs in forty-six countries and forty-six supplementary protection certificates in nine countries.

Summary for Salix Pharms

International Patents:393
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 PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► SubscribeY► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► SubscribeY► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► SubscribeY► Subscribe
Salix PharmsXIFAXANrifaximinTABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► SubscribeY► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► SubscribeY► Subscribe
Salix PharmsXIFAXANrifaximinTABLET;ORAL021361-001May 25, 2004RXYesYes► Subscribe► SubscribeYY► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► Subscribe► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► SubscribeY► Subscribe
Salix Pharms IncRELISTORmethylnaltrexone bromideTABLET;ORAL208271-001Jul 19, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Salix Pharms IncRELISTORmethylnaltrexone bromideTABLET;ORAL208271-001Jul 19, 2016RXYesYes► 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 PharmsMETOZOLV ODTmetoclopramide hydrochlorideTABLET, ORALLY DISINTEGRATING;ORAL022246-002Sep 4, 2009► Subscribe► Subscribe
Salix PharmsVISICOLsodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrateTABLET;ORAL021097-001Sep 21, 2000► Subscribe► Subscribe
Salix PharmsPEPCIDfamotidineFOR SUSPENSION;ORAL019527-001Feb 2, 1987► Subscribe► Subscribe
Salix PharmsMETOZOLV ODTmetoclopramide hydrochlorideTABLET, ORALLY DISINTEGRATING;ORAL022246-001Sep 4, 2009► Subscribe► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-001Apr 24, 2008► Subscribe► Subscribe
Salix PharmsOSMOPREPsodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrateTABLET;ORAL021892-001Mar 16, 2006► Subscribe► Subscribe
Salix Pharms IncRELISTORmethylnaltrexone bromideTABLET;ORAL208271-001Jul 19, 2016► Subscribe► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010► Subscribe► Subscribe
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Paragraph IV activity for SALIX PHARMS drugs

Drugname Dosage Strength Tradename Submissiondate
methylnaltrexone bromideTablets150 mgRELISTOR9/6/2016
rifaximinTablets550 mgXIFAXAN12/18/2015
methylnaltrexone bromideInjection8 mg/0.4 mLRELISTOR9/8/2015
methylnaltrexone bromideInjection12 mg/0.6 mLRELISTOR7/22/2015
metoclopramide hydrochlorideOrally Disintegrating Tablets5 mg and 10 mgMETOZOLV ODT8/24/2010
sodium phosphate monobasic monohydrate and sodium phosphatedibasic anhydrous, uspTablets1.102 g and 0.398 gOSMOPREP4/9/2008
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 pouchMOVIPREP11/27/2007

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
8,388,935Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions► Subscribe
8,110,177Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions► Subscribe
8,507,009Colonic purgative composition with soluble binding agent► Subscribe
6,562,629 METHOD OF DIAGNOSING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH BY DETECTING THE PRESENCE OF ANTI-SACCHAROMYCES CERIVISIAE ANTIBODIES (ASCA) IN HUMAN SERUM► Subscribe
9,358,276Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions► Subscribe
9,566,270Methods for treating irritable bowel syndrome (IBS)► Subscribe
7,615,207Methods for treating irritable bowel syndrome► Subscribe
7,244,412Methods for manipulating upper gastrointestinal transit, blood flow, and satiety, and for treating visceral hyperalgesia► Subscribe
5,976,577 Process for preparing fast dispersing solid oral dosage form► Subscribe
8,173,801Processes for the production of polymorphic forms of rifaximin► 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
Russian Federation2014104362► Subscribe
Israel221452► Subscribe
Germany20321510► Subscribe
Russian Federation2519649► Subscribe
Spain2522895► Subscribe
Canada2765577► Subscribe
European Patent Office1557421► Subscribe
World Intellectual Property Organization (WIPO)2010148040► Subscribe
South Korea100883216► Subscribe
TaiwanI285107► 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
C/GB98/040United Kingdom► SubscribePRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508
99C0030Belgium► SubscribePRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
C0108Belgium► SubscribePRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
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
666Luxembourg► SubscribePRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
C/GB98/031United Kingdom► SubscribePRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
C/GB98/030United Kingdom► SubscribePRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
12/018Ireland► SubscribePRODUCT 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
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
C0009Belgium► SubscribePRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
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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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Serving leading biopharmaceutical companies globally:

Harvard Business School
Novartis
Daiichi Sankyo
Chubb
Cantor Fitzgerald
Moodys
McKinsey
Federal Trade Commission
Merck
Queensland Health

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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