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Generated: September 25, 2017
What is the competitive landscape for SALIX PHARMS, and when can generic versions of SALIX PHARMS drugs launch?
SALIX PHARMS has eleven approved drugs.| Patents: | 42 |
| Tradenames: | 9 |
| Ingredients: | 9 |
| NDAs: | 11 |
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Salix Pharms | PEPCID | famotidine | FOR SUSPENSION;ORAL | 019527-001 | Feb 2, 1987 | ► Subscribe | ► Subscribe | ||||||||
Salix Pharms | OSMOPREP | sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate | TABLET;ORAL | 021892-001 | Mar 16, 2006 | ► Subscribe | ► Subscribe | ||||||||
Salix Pharms | METOZOLV ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 022246-002 | Sep 4, 2009 | ► Subscribe | ► Subscribe | ||||||||
Salix Pharms | VISICOL | sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate | TABLET;ORAL | 021097-001 | Sep 21, 2000 | ► Subscribe | ► Subscribe | ||||||||
Salix Pharms | METOZOLV ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 022246-001 | Sep 4, 2009 | ► Subscribe | ► Subscribe | ||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
methylnaltrexone bromide | Tablets | 150 mg | RELISTOR | 9/6/2016 |
rifaximin | Tablets | 550 mg | XIFAXAN | 12/18/2015 |
methylnaltrexone bromide | Injection | 8 mg/0.4 mL | RELISTOR | 9/8/2015 |
methylnaltrexone bromide | Injection | 12 mg/0.6 mL | RELISTOR | 7/22/2015 |
metoclopramide hydrochloride | Orally Disintegrating Tablets | 5 mg and 10 mg | METOZOLV ODT | 8/24/2010 |
sodium phosphate monobasic monohydrate and sodium phosphatedibasic anhydrous, usp | Tablets | 1.102 g and 0.398 g | OSMOPREP | 4/9/2008 |
polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and | For Oral Solution | 100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch | MOVIPREP | 11/27/2007 |
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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,718,197 | Colonic purgative composition with soluble binding agent | ► Subscribe | |||||||||||||
| 9,629,829 | Methods of treating hepatic encephalopathy | ► Subscribe | |||||||||||||
| 9,358,276 | Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions | ► Subscribe | |||||||||||||
| 7,608,245 | Methods for manipulating satiety | ► Subscribe | |||||||||||||
| 5,976,577 | Process for preparing fast dispersing solid oral dosage form | ► Subscribe | |||||||||||||
| 8,404,704 | Use 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 | |||||||||||||
| 7,048,906 | Methods 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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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 602004006367 | ► Subscribe | |||||||||||||
| Mexico | 2010009197 | ► Subscribe | |||||||||||||
| European Patent Office | 2261665 | ► Subscribe | |||||||||||||
| Mexico | 9708858 | ► Subscribe | |||||||||||||
| Serbia | 54568 | ► Subscribe | |||||||||||||
| Brazil | PI0407149 | ► Subscribe | |||||||||||||
| Japan | 2005509588 | ► Subscribe | |||||||||||||
| Japan | 6143409 | ► Subscribe | |||||||||||||
| Japan | 2007509904 | ► Subscribe | |||||||||||||
| Tunisia | SN06069 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB10/012 | United Kingdom | ► Subscribe | PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112 | ||||||||||||
| C/GB02/042 | United Kingdom | ► Subscribe | PRODUCT 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 | ||||||||||||
| 99C0030 | Belgium | ► Subscribe | PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508 | ||||||||||||
| 90018-6 | Sweden | ► Subscribe | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 | ||||||||||||
| C0005 | Belgium | ► Subscribe | PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204 | ||||||||||||
| C0009 | Belgium | ► Subscribe | PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015 | ||||||||||||
| 2015 00014 | Denmark | ► Subscribe | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115 | ||||||||||||
| 14/058 | Ireland | ► Subscribe | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516 | ||||||||||||
| C0055 | France | ► Subscribe | PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220 | ||||||||||||
| C0076 | France | ► Subscribe | PRODUCT 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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Serving 500+ biopharmaceutical companies globally:
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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