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Mallinckrodt
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Last Updated: April 12, 2021

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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 Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes 10,456,384   Start Trial   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes 7,612,199   Start Trial Y Y   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-001 May 25, 2004 RX Yes Yes 7,928,115   Start Trial   Start Trial
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   Start Trial Y Y   Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 RX Yes Yes 10,314,828   Start Trial   Start Trial
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 9,707,297   Start Trial Y   Start Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes 10,011,637   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 Pharms XIFAXAN rifaximin TABLET;ORAL 022554-001 Mar 24, 2010 7,452,857   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate CAPSULE;ORAL 021849-001 Feb 27, 2006 6,645,988   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 6,489,346   Start Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 8,784,888   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate CAPSULE;ORAL 021849-002 Feb 27, 2006 6,645,988   Start Trial
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-002 Dec 21, 2004 5,840,737   Start Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 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 Orally Disintegrating Tablets 5 mg and 10 mg ➤ Subscribe 2010-08-24
➤ Subscribe Tablets 550 mg ➤ Subscribe 2015-12-18
➤ 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 Tablets 9 mg ➤ Subscribe 2013-03-11
➤ 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

Supplementary Protection Certificates for Salix Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2822954 1890030-8 Sweden   Start Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
0290047 SPC/GB97/078 United Kingdom   Start Trial PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
1499331 SPC/GB13/034 United Kingdom   Start Trial 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
1912999 2014/058 Ireland   Start Trial PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
1856135 CA 2020 00018 Denmark   Start Trial PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
1602370 SPC/GB09/024 United Kingdom   Start Trial PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
0480717 98C0022 France   Start Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
>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.

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Moodys
Mallinckrodt
Baxter
Medtronic

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