SALIX Company Profile
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What is the competitive landscape for SALIX, and what generic alternatives to SALIX drugs are available?
SALIX has eighteen approved drugs.
There are seventy-five US patents protecting SALIX drugs.
There are six hundred and forty-seven patent family members on SALIX drugs in fifty-five countries and ninety-seven supplementary protection certificates in twelve countries.
Summary for SALIX
| International Patents: | 647 |
| US Patents: | 75 |
| 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 | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | 7,902,206 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | 10,456,384 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | 7,612,199 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Salix | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | RX | Yes | Yes | 9,180,125 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | 10,709,694 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | RX | Yes | Yes | 8,835,452 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 | TRULANCE | plecanatide | TABLET;ORAL | 208745-001 | Jan 19, 2017 | 8,637,451 | ⤷ Try a Trial |
| Salix | UCERIS | budesonide | TABLET, EXTENDED RELEASE;ORAL | 203634-001 | Jan 14, 2013 | RE43799 | ⤷ Try a Trial |
| Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-002 | Dec 21, 2004 | 6,489,346 | ⤷ Try a Trial |
| Salix | ZEGERID | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 021636-002 | Dec 21, 2004 | 5,840,737 | ⤷ Try a Trial |
| Salix | ZEGERID | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 021849-001 | Feb 27, 2006 | 6,645,988 | ⤷ Try a Trial |
| Salix | APRISO | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 022301-001 | Oct 31, 2008 | 8,956,647 | ⤷ Try a Trial |
| >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 | 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 |
| ➤ 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 |
International Patents for SALIX Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 598671 | ⤷ Try a Trial |
| China | 1355693 | ⤷ Try a Trial |
| Eurasian Patent Organization | 029096 | ⤷ Try a Trial |
| Hong Kong | 1077196 | ⤷ Try a Trial |
| Japan | 2011057698 | ⤷ Try a Trial |
| Singapore | 11201501713X | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SALIX Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1507558 | 12C0033 | France | ⤷ Try a Trial | 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: CH - 6167801 20110705 |
| 1602370 | 09C0020 | France | ⤷ Try a Trial | 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 |
| 0268956 | 1999C0030 | Belgium | ⤷ Try a Trial | PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508 |
| 0480717 | 98C0022 | France | ⤷ Try a Trial | PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825 |
| 1948158 | 93075 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN, C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3'-METHYL-2-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123 |
| 0454511 | SPC/GB99/008 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015 |
| >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.
