Santarus Company Profile
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What is the competitive landscape for SANTARUS, and what generic alternatives to SANTARUS drugs are available?
SANTARUS has three approved drugs.
There is one US patent protecting SANTARUS drugs.
There are twenty-three patent family members on SANTARUS drugs in fourteen countries and sixty-seven supplementary protection certificates in fifteen countries.
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
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 | 022456-002 | Dec 4, 2009 | 6,489,346 | ⤷ Try a Trial |
Santarus | ZEGERID | magnesium hydroxide; omeprazole; sodium bicarbonate | TABLET, CHEWABLE;ORAL | 021850-002 | Mar 24, 2006 | 6,489,346 | ⤷ Try a Trial |
Santarus | MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE | magnesium hydroxide; omeprazole; sodium bicarbonate | TABLET;ORAL | 022456-002 | Dec 4, 2009 | 6,699,885 | ⤷ Try a Trial |
>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 | 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 |
International Patents for Santarus Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2010155864 | ⤷ Try a Trial |
Japan | 2005526047 | ⤷ Try a Trial |
Canada | 2476496 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
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
Here is a list of applicants with similar names.