Serving 500+ biopharmaceutical companies globally:
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
Serving 500+ biopharmaceutical companies globally:
Generated: July 22, 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: | 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;ORAL | 022554-001 | Mar 24, 2010 | RX | Yes | Yes | 7,902,206 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | 7,906,542 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Salix Pharms Inc | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | RX | Yes | Yes | 8,524,276 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | 8,835,452 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-002 | Sep 27, 2010 | RX | Yes | Yes | 8,247,425 | ► Subscribe | ► Subscribe | ||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| 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 | 5,616,346 | ► Subscribe | ||||||||||||||||||||||
Salix Pharms | PEPCID | famotidine | FOR SUSPENSION;ORAL | 019527-001 | Feb 2, 1987 | 4,283,408*PED | ► Subscribe | ||||||||||||||||||||||
Salix Pharms | METOZOLV ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 022246-002 | Sep 4, 2009 | 6,413,549 | ► Subscribe | ||||||||||||||||||||||
Salix Pharms | OSMOPREP | sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate | TABLET;ORAL | 021892-001 | Mar 16, 2006 | 5,616,346 | ► Subscribe | ||||||||||||||||||||||
Salix Pharms | METOZOLV ODT | metoclopramide hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 022246-001 | Sep 4, 2009 | 6,413,549 | ► Subscribe | ||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,244,412 | Methods for manipulating upper gastrointestinal transit, blood flow, and satiety, and for treating visceral hyperalgesia | ► Subscribe | |||||||||||||||||||||||||||
| 8,562,952 | Methods for manipulating satiety | ► Subscribe | |||||||||||||||||||||||||||
| 5,977,175 | Methods and compositions for improving digestion and absorption in the small intestine | ► Subscribe | |||||||||||||||||||||||||||
| 8,173,801 | Processes 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 | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Russian Federation | 2397985 | ► Subscribe | |||||||||||||||||||||||||||
| Serbia | 54570 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20130010900 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2009227838 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2014104362 | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB98/040 | United Kingdom | ► Subscribe | PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508 | ||||||||||||||||||||||||||
| 14/032 | Ireland | ► Subscribe | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 | ||||||||||||||||||||||||||
| 12/018 | Ireland | ► Subscribe | PRODUCT 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 | ||||||||||||||||||||||||||
| C0033 | France | ► Subscribe | PRODUCT 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 00014 | Denmark | ► Subscribe | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115 | ||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
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.
Follow DrugPatentWatch:
Join the 22,078 other biopharmaceutical professionals who get our Drug Patent Expiration Alerts:
