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 | 8,741,904 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-003 | Sep 27, 2010 | AP | RX | Yes | Yes | 9,669,096 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| 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 | 10,780,112 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Salix | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | RX | Yes | Yes | 9,616,097 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Salix | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | RX | Yes | Yes | 8,524,276 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | RX | Yes | Yes | 9,492,445 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | RE43799 | ⤷ Sign Up |
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-003 | Sep 27, 2010 | 8,552,025 | ⤷ Sign Up |
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | 6,559,158 | ⤷ Sign Up |
| Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-001 | Jun 15, 2004 | 5,840,737 | ⤷ Sign Up |
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | 7,902,206 | ⤷ Sign Up |
| Salix | ZEGERID | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 021849-002 | Feb 27, 2006 | 6,645,988 | ⤷ Sign Up |
| >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 | 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 |
| ➤ Subscribe | Tablets | 550 mg | ➤ Subscribe | 2015-12-18 |
International Patents for SALIX Drugs
Supplementary Protection Certificates for SALIX Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3141251 | C202130017 | Spain | ⤷ Sign Up | PRODUCT NAME: COMBINACION DE PRINCIPIOS ACTIVOS EN DOS DOSIS, EN LA QUE LA PRIMERA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, SULFATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO, Y LA SEGUNDA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, ACIDO ASCORBICO, ASCORBATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO.; NATIONAL AUTHORISATION NUMBER: 82959-SE/H/1801/001/DC; DATE OF AUTHORISATION: 20180525; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): IS/1/17/083/01; DATE OF FIRST AUTHORISATION IN EEA: 20171016 |
| 2822954 | SPC/GB18/031 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625 |
| 3141251 | 122021000018 | Germany | ⤷ Sign Up | PRODUCT NAME: EIN ARZNEIMITTEL BESTEHEND AUS EINER KOMBINATION EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG FUER EINE ERSTE DOSIS UND EINER PHARMAZEUTISCHEN ZUSAMMENSETZUNG FUER EINE ZWEITE DOSIS, WOBEI DIE PHARMAZEUTISCHE ZUSAMMENSETZUNG FUER DIE ERSTE DOSIS AUS DEN WIRKSTOFFEN POLYETHYLENGLYCOL, NATRIUMSULFAT, NATRIUMCHLORID UND KALIUMCHLORID BESTEHT UND DIE PHARMAZEUTISCHE ZUSAMMENSETZUNG FUER DIE ZWEITE DOSIS AUS DEN; NAT. REGISTRATION NO/DATE: 98450.00.00 20180205; FIRST REGISTRATION: ISLAND IS/1/17/083/01 20171016 |
| 0733366 | SPC/GB98/031 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412 |
| 1874117 | 2014/032 | Ireland | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 |
| 0565634 | 06C0030 | France | ⤷ Sign Up | PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607 |
| >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.
