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Generated: October 21, 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.| International Patents: | 398 |
| US 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 | VISICOL | sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate | TABLET;ORAL | 021097-001 | Sep 21, 2000 | ► Subscribe | ► Subscribe | ||||||||
Salix Pharms | PEPCID | famotidine | FOR SUSPENSION;ORAL | 019527-001 | Feb 2, 1987 | ► Subscribe | ► Subscribe | ||||||||
Salix Pharms | METOZOLV ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 022246-002 | Sep 4, 2009 | ► 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 | 022246-001 | 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,977,175 | Methods and compositions for improving digestion and absorption in the small intestine | ► Subscribe | |||||||||||||
| 9,566,270 | Methods for treating irritable bowel syndrome (IBS) | ► Subscribe | |||||||||||||
| 8,110,177 | Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions | ► Subscribe | |||||||||||||
| 7,615,207 | Methods for treating irritable bowel syndrome | ► Subscribe | |||||||||||||
| 7,585,838 | Methods of treating fibromyalgia caused by small intestinal bacterial overgrowth | ► Subscribe | |||||||||||||
| 8,388,935 | Methods 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 | |||||||||||||
| 8,173,801 | Processes for the production of polymorphic forms of rifaximin | ► Subscribe | |||||||||||||
| 8,455,644 | Peripheral 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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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Israel | 212055 | ► Subscribe | |||||||||||||
| European Patent Office | 2210893 | ► Subscribe | |||||||||||||
| Russian Federation | 2007136430 | ► Subscribe | |||||||||||||
| European Patent Office | 1557421 | ► Subscribe | |||||||||||||
| Portugal | 2256498 | ► Subscribe | |||||||||||||
| World Intellectual Property Organization (WIPO) | 2006094662 | ► Subscribe | |||||||||||||
| Germany | 60322940 | ► Subscribe | |||||||||||||
| World Intellectual Property Organization (WIPO) | 2009108814 | ► Subscribe | |||||||||||||
| Slovenia | EP1698630 | ► Subscribe | |||||||||||||
| South Korea | 20120045015 | ► 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.
Export unavailable in trial.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90064-1 | Sweden | ► Subscribe | PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 | ||||||||||||
| 90020-1 | Sweden | ► Subscribe | PRODUCT 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/GB08/036 | United Kingdom | ► Subscribe | PRODUCT 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/GB02/042 | 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 | ||||||||||||
| 90062-5 | Sweden | ► Subscribe | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 | ||||||||||||
| 90018-6 | Sweden | ► Subscribe | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 | ||||||||||||
| C0052 | France | ► Subscribe | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 | ||||||||||||
| 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 | ||||||||||||
| C/GB97/078 | United Kingdom | ► Subscribe | PRODUCT 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 | ||||||||||||
| C0020 | France | ► Subscribe | PRODUCT 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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Serving leading 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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