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Last Updated: April 29, 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 Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 AB3 RX Yes No ⤷  Try a Trial ⤷  Try a Trial
Santarus MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE magnesium hydroxide; omeprazole; sodium bicarbonate TABLET;ORAL 022456-002 Dec 4, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 AB3 RX Yes Yes 7,780,987 ⤷  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 Santarus

Paragraph IV (Patent) Challenges for SANTARUS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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 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

Supplementary Protection Certificates for Santarus Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 C 2008 016 Romania ⤷  Try a Trial PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
2498758 LUC00152 Luxembourg ⤷  Try a Trial PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1261586 12C0028 France ⤷  Try a Trial PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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