SALIX Company Profile
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What is the competitive landscape for SALIX, and when can generic versions of SALIX drugs launch?
SALIX has eighteen approved drugs.
There are seventy-six US patents protecting SALIX drugs.
There are six hundred and fifty-six patent family members on SALIX drugs in fifty-five countries and ninety-seven supplementary protection certificates in twelve countries.
Summary for SALIX
| International Patents: | 656 |
| US Patents: | 76 |
| Tradenames: | 15 |
| Ingredients: | 13 |
| NDAs: | 18 |
| Patent Litigation for SALIX: | See patent lawsuits for SALIX |
| PTAB Cases with SALIX as patent owner: | See PTAB cases with SALIX as patent owner |
Drugs and US Patents for SALIX
| 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 | 021361-001 | May 25, 2004 | RX | Yes | Yes | 10,703,763 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | 8,835,452 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Salix | PLENVU | ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 209381-001 | May 4, 2018 | RX | Yes | Yes | 9,592,252 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SALIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Salix | FENOGLIDE | fenofibrate | TABLET;ORAL | 022118-001 | Aug 10, 2007 | 8,124,125 | ⤷ Subscribe |
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | 8,835,452 | ⤷ Subscribe |
| Salix | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | 6,559,158 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for SALIX drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 550 mg | ➤ Subscribe | 2015-12-18 |
| ➤ Subscribe | Extended-release Tablets | 9 mg | ➤ Subscribe | 2013-03-11 |
| ➤ Subscribe | Capsules | 20 mg/1100 mg and 40 mg/1100 mg | ➤ Subscribe | 2007-04-30 |
| ➤ Subscribe | Powder for Oral Suspension | 20mg/1680mg per packet | ➤ Subscribe | 2007-11-13 |
| ➤ Subscribe | Tablets | 40 mg and 120 mg | ➤ Subscribe | 2010-03-17 |
| ➤ Subscribe | Injection | 8 mg/0.4 mL | ➤ Subscribe | 2015-09-08 |
| ➤ Subscribe | For Oral Solution | 100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch | ➤ Subscribe | 2007-11-27 |
| ➤ Subscribe | Tablets | 1.102 g and 0.398 g | ➤ Subscribe | 2008-04-09 |
| ➤ Subscribe | Tablets | 200 mg | ➤ Subscribe | 2019-01-28 |
| ➤ Subscribe | Extended-release Capsules | 0.375 g | ➤ Subscribe | 2012-04-03 |
| ➤ Subscribe | Powder for Oral Suspension | 40 mg/1680 mg per packet | ➤ Subscribe | 2007-08-24 |
| ➤ Subscribe | For Oral Solution | 140 g, 5.2 g, 2.2.g, 48.11 g, 9g and 7.54 g per pouch | ➤ Subscribe | 2018-12-06 |
| ➤ Subscribe | Injection | 12 mg/0.6 mL | ➤ Subscribe | 2015-07-22 |
| ➤ Subscribe | Tablets | 150 mg | ➤ Subscribe | 2016-09-06 |
| ➤ Subscribe | Orally Disintegrating Tablets | 5 mg and 10 mg | ➤ Subscribe | 2010-08-24 |
International Patents for SALIX Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Chile | 2011000744 | ⤷ Subscribe |
| Spain | 2622468 | ⤷ Subscribe |
| Russian Federation | 2010139475 | ⤷ Subscribe |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SALIX Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2435024 | 21C1020 | France | ⤷ Subscribe | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
| 2435024 | SPC/GB21/029 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210 |
| 0473687 | SPC/GB98/030 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
