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.
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 | 021748-002 | Jun 3, 2005 | AB3 | RX | Yes | Yes | 7,780,987 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
| Santarus | ZEGERID | magnesium hydroxide; omeprazole; sodium bicarbonate | TABLET, CHEWABLE;ORAL | 021850-001 | Mar 24, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Santarus | MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE | magnesium hydroxide; omeprazole; sodium bicarbonate | TABLET;ORAL | 022456-001 | 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 | ||||
| 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 | |||||
| >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 |
| Santarus | ZEGERID | magnesium hydroxide; omeprazole; sodium bicarbonate | TABLET, CHEWABLE;ORAL | 021850-001 | Mar 24, 2006 | 6,699,885 | ⤷ Try a Trial |
| Santarus | MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE | magnesium hydroxide; omeprazole; sodium bicarbonate | TABLET;ORAL | 022456-002 | Dec 4, 2009 | 7,399,772 | ⤷ 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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 03072089 | ⤷ Try a Trial |
| New Zealand | 535455 | ⤷ Try a Trial |
| Mexico | PA04008100 | ⤷ Try a Trial |
| Canada | 2476496 | ⤷ Try a Trial |
| Norway | 20043913 | ⤷ 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 |
|---|---|---|---|---|
| 0984957 | 2012/048 | Ireland | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812 |
| 1261586 | 132012902044560 | Italy | ⤷ Try a Trial | 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 |
| 0984957 | CR 2012 00035 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105 |
| 0984957 | C300483 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524 |
| 2498758 | 2020C/509 | Belgium | ⤷ Try a Trial | PRODUCT NAME: QTRILMET - 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 |
| >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.
Here is a list of applicants with similar names.
