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Serving 500+ biopharmaceutical companies globally:

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Generated: September 25, 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-two patent family members on SALIX PHARMS drugs in forty-five countries.

Summary for Applicant: Salix Pharms

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
RELISTOR
methylnaltrexone bromide
SOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Salix Pharms
DIURIL
chlorothiazide
SUSPENSION;ORAL011870-001Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe► Subscribe
Salix Pharms
RELISTOR
methylnaltrexone bromide
SOLUTION;SUBCUTANEOUS021964-003Sep 27, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Salix Pharms
RELISTOR
methylnaltrexone bromide
SOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Salix Pharms
RELISTOR
methylnaltrexone bromide
SOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► 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
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Salix Pharms
ANUSOL HC
hydrocortisone
CREAM;TOPICAL088250-001Jun 6, 1984ATRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Salix Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms
PEPCID
famotidine
FOR SUSPENSION;ORAL019527-001Feb 2, 1987► 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;ORAL022246-002Sep 4, 2009► Subscribe► Subscribe
Salix Pharms
VISICOL
sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL021097-001Sep 21, 2000► 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
7,718,197Colonic purgative composition with soluble binding agent► Subscribe
9,629,829Methods of treating hepatic encephalopathy► Subscribe
9,358,276Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions► Subscribe
7,608,245Methods for manipulating satiety► Subscribe
5,976,577 Process for preparing fast dispersing solid oral dosage form► Subscribe
8,404,704Use of polymorphic forms of rifaximin for medical preparations► Subscribe
6,805,852 Methods of diagnosing irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth► Subscribe
7,048,906Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions► 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
6,608,075 Use of methylnaltrexone and related compounds► 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
Germany602004006367► Subscribe
Mexico2010009197► Subscribe
European Patent Office2261665► Subscribe
Mexico9708858► Subscribe
Serbia54568► Subscribe
BrazilPI0407149► Subscribe
Japan2005509588► Subscribe
Japan6143409► Subscribe
Japan2007509904► Subscribe
TunisiaSN06069► 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/GB10/012United Kingdom► SubscribePRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
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
99C0030Belgium► SubscribePRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
90018-6Sweden► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
C0005Belgium► SubscribePRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
C0009Belgium► SubscribePRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
2015 00014Denmark► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
14/058Ireland► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
C0055France► SubscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
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
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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 500+ biopharmaceutical companies globally:

Cipla
Accenture
Cantor Fitzgerald
Johnson and Johnson
AstraZeneca
Federal Trade Commission
Deloitte
Novartis
Farmers Insurance
QuintilesIMS

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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