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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Cerilliant
Boehringer Ingelheim
Cantor Fitzgerald
Daiichi Sankyo
Johnson and Johnson
Julphar
Baxter
US Army
AstraZeneca

Generated: July 22, 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 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 eighty-five patent family members on SALIX PHARMS drugs in forty-five countries.

Summary for Applicant: Salix Pharms

Patents:40
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
XIFAXAN
rifaximin
TABLET;ORAL022554-001Mar 24, 2010RXYesYes7,902,206► SubscribeYY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL021361-001May 25, 2004RXYesYes7,906,542► SubscribeYY ► Subscribe
Salix Pharms Inc
RELISTOR
methylnaltrexone bromide
TABLET;ORAL208271-001Jul 19, 2016RXYesYes8,524,276► SubscribeY ► Subscribe
Salix Pharms
XIFAXAN
rifaximin
TABLET;ORAL021361-001May 25, 2004RXYesYes8,835,452► SubscribeYY ► Subscribe
Salix Pharms
RELISTOR
methylnaltrexone bromide
SOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes8,247,425► 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
VISICOL
sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL021097-001Sep 21, 20005,616,346► Subscribe
Salix Pharms
PEPCID
famotidine
FOR SUSPENSION;ORAL019527-001Feb 2, 19874,283,408*PED► Subscribe
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-002Sep 4, 20096,413,549► Subscribe
Salix Pharms
OSMOPREP
sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
TABLET;ORAL021892-001Mar 16, 20065,616,346► Subscribe
Salix Pharms
METOZOLV ODT
metoclopramide hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL022246-001Sep 4, 20096,413,549► 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
7,244,412Methods for manipulating upper gastrointestinal transit, blood flow, and satiety, and for treating visceral hyperalgesia► Subscribe
8,562,952Methods for manipulating satiety► Subscribe
5,977,175 Methods and compositions for improving digestion and absorption in the small intestine► Subscribe
8,173,801Processes for the production of polymorphic forms of rifaximin► Subscribe
6,558,708 Methods for manipulating upper gastrointestinal transit, blood flow, and satiety, and for treating visceral hyperalgesia► 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 Federation2397985► Subscribe
Serbia54570► Subscribe
South Korea20130010900► Subscribe
Australia2009227838► Subscribe
Russian Federation2014104362► 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
14/032Ireland► SubscribePRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
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
C0033France► SubscribePRODUCT 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
2015 00014Denmark► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
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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:

Farmers Insurance
Fuji
Healthtrust
Chinese Patent Office
UBS
Moodys
Novartis
Cerilliant
Daiichi Sankyo
Medtronic

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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