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Last Updated: November 17, 2019

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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 ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 AB RX Yes No   Start Trial   Start Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes 9,925,231   Start Trial Y   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-001 May 25, 2004 RX Yes Yes 8,193,196   Start Trial Y Y   Start Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes 8,637,451   Start Trial   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes 8,946,252   Start Trial   Start Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes 10,011,637   Start Trial Y   Start Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 RX Yes Yes 9,669,096   Start Trial Y   Start 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 ZEGERID omeprazole; sodium bicarbonate CAPSULE;ORAL 021849-002 Feb 27, 2006 6,699,885   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 7,605,240   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-002 Dec 21, 2004 6,699,885   Start Trial
Salix Pharms OSMOPREP sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021892-001 Mar 16, 2006 5,616,346   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 6,861,053   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate CAPSULE;ORAL 021849-001 Feb 27, 2006 6,489,346   Start Trial
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 6,559,158   Start 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 Tablets 1.102 g and 0.398 g ➤ Subscribe 2008-04-09
➤ Subscribe Tablets 200 mg ➤ Subscribe 2019-01-28
➤ 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 Extended-release Tablets 9 mg ➤ Subscribe 2013-03-11
➤ 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 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 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

Supplementary Protection Certificates for Salix Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0268956 SPC/GB98/040 United Kingdom   Start Trial 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
1874117 2014/032 Ireland   Start Trial PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
2203431 2015/009 Ireland   Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
1713823 92595 Luxembourg   Start Trial PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
1499331 13C0055 France   Start Trial PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
1912999 14C0076 France   Start Trial PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516
1602370 09C0020 France   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Dow
Harvard Business School
Colorcon
McKinsey

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