Santarus Company Profile
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What is the competitive landscape for SANTARUS, and when can generic versions of SANTARUS drugs launch?
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 | 021748-002 | Jun 3, 2005 | AB3 | RX | Yes | Yes | 7,780,987 | ⤷ Try a Trial | Y | Y | ⤷ 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 | 021748-001 | Jun 3, 2005 | AB3 | RX | Yes | No | ⤷ Try a Trial | ⤷ 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 Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | 6,635,280 | ⤷ Try a Trial |
Santarus Inc | GLUMETZA | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021748-001 | Jun 3, 2005 | 6,488,962 | ⤷ Try a Trial |
Santarus | MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE | magnesium hydroxide; omeprazole; sodium bicarbonate | TABLET;ORAL | 022456-001 | Dec 4, 2009 | 6,489,346 | ⤷ 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 | 2005526047 | ⤷ Try a Trial |
Slovenia | 1476138 | ⤷ Try a Trial |
Australia | 2003211146 | ⤷ 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 |
---|---|---|---|---|
1261586 | 2012C/016 | Belgium | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128 |
1261586 | C300524 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION: |
1506211 | CA 2014 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.