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Last Updated: July 16, 2024

Santarus Company Profile


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Summary for Santarus
International Patents:23
US Patents:1
Tradenames:3
Ingredients:2
NDAs:3

Drugs and US Patents for Santarus

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Santarus ZEGERID magnesium hydroxide; omeprazole; sodium bicarbonate TABLET, CHEWABLE;ORAL 021850-002 Mar 24, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 AB3 RX Yes Yes 7,780,987 ⤷  Sign Up Y Y ⤷  Sign Up
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 AB3 RX Yes No ⤷  Sign Up ⤷  Sign Up
Santarus ZEGERID magnesium hydroxide; omeprazole; sodium bicarbonate TABLET, CHEWABLE;ORAL 021850-001 Mar 24, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up
Santarus MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE magnesium hydroxide; omeprazole; sodium bicarbonate TABLET;ORAL 022456-002 Dec 4, 2009 DISCN No No ⤷  Sign Up ⤷  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 Santarus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE magnesium hydroxide; omeprazole; sodium bicarbonate TABLET;ORAL 022456-001 Dec 4, 2009 7,399,772 ⤷  Sign Up
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 6,723,340 ⤷  Sign Up
Santarus ZEGERID magnesium hydroxide; omeprazole; sodium bicarbonate TABLET, CHEWABLE;ORAL 021850-002 Mar 24, 2006 6,489,346 ⤷  Sign Up
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 6,488,962 ⤷  Sign Up
Santarus ZEGERID magnesium hydroxide; omeprazole; sodium bicarbonate TABLET, CHEWABLE;ORAL 021850-002 Mar 24, 2006 6,645,988 ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SANTARUS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Powder for Oral Suspension 40 mg/1680 mg per packet ➤ Subscribe 2007-08-24
➤ Subscribe Extended-release Tablets 500 mg and 1000 mg ➤ Subscribe 2009-07-27
➤ 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

Supplementary Protection Certificates for Santarus Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 132012902044560 Italy ⤷  Sign Up PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
0861666 07C0006 France ⤷  Sign Up PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
1412357 50/2008 Austria ⤷  Sign Up PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
1506211 PA2014026,C1506211 Lithuania ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211 SPC/GB14/050 United Kingdom ⤷  Sign Up PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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