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Last Updated: December 12, 2024

Salix Company Profile


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Summary for Salix

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 UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes 8,895,064 ⤷  Sign Up Y ⤷  Sign Up
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes 7,906,542 ⤷  Sign Up Y Y ⤷  Sign Up
Salix Pharms MOVIPREP ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 021881-001 Aug 2, 2006 AA RX Yes Yes 7,658,914 ⤷  Sign Up Y Y ⤷  Sign Up
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes 11,564,912 ⤷  Sign Up ⤷  Sign Up
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 RX Yes Yes 9,669,096 ⤷  Sign Up Y ⤷  Sign Up
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes 10,011,637 ⤷  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 ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 6,699,885 ⤷  Sign Up
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 6,489,346 ⤷  Sign Up
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 8,956,647 ⤷  Sign Up
Salix FENOGLIDE fenofibrate TABLET;ORAL 022118-002 Aug 10, 2007 8,124,125 ⤷  Sign Up
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-002 Sep 27, 2010 8,552,025 ⤷  Sign Up
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 7,399,772 ⤷  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 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
➤ 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

Supplementary Protection Certificates for Salix Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0806968 SPC/GB07/011 United Kingdom ⤷  Sign Up PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
1499331 SPC/GB13/034 United Kingdom ⤷  Sign Up PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
2666774 LUC00167 Luxembourg ⤷  Sign Up PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
2203431 1590018-6 Sweden ⤷  Sign Up PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
1948158 16C0018 France ⤷  Sign Up PRODUCT NAME: SACUBITRIL/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'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
2203431 CR 2015 00014 Denmark ⤷  Sign Up PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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