SANTARUS Company Profile

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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.

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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	021850-001	Mar 24, 2006		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 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	021850-002	Mar 24, 2006		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

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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
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-002	Mar 24, 2006	6,699,885	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498758	PA2020003,C2498758	Lithuania	⤷ Try a Trial	PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1499331	SPC/GB13/034	United Kingdom	⤷ Try a Trial	PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
1499331	13C0055	France	⤷ Try a Trial	PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
1506211	C 2014 029	Romania	⤷ Try a Trial	PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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