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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cerilliant
Federal Trade Commission
McKesson
Merck
Cipla
Mallinckrodt
Chubb
Novartis
Julphar

Generated: December 17, 2017

DrugPatentWatch Database Preview

Santarus Inc Company Profile

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What is the competitive landscape for SANTARUS INC, and what generic alternatives to SANTARUS INC drugs are available?

SANTARUS INC has four approved drugs.

There are seventeen US patents protecting SANTARUS INC drugs.

There are one hundred and fifty-five patent family members on SANTARUS INC drugs in twenty-six countries and thirty-two supplementary protection certificates in eleven countries.

Summary for Santarus Inc

International Patents:155
US Patents:17
Tradenames:3
Ingredients:3
NDAs:4
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Santarus IncFENOGLIDEfenofibrateTABLET;ORAL022118-001Aug 10, 2007ABRXYesNo► Subscribe► SubscribeY► Subscribe
Santarus IncFENOGLIDEfenofibrateTABLET;ORAL022118-001Aug 10, 2007ABRXYesNo► Subscribe► SubscribeY► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-002Dec 21, 2004ABRXYesYes► Subscribe► Subscribe► Subscribe
Santarus IncFENOGLIDEfenofibrateTABLET;ORAL022118-002Aug 10, 2007ABRXYesYes► Subscribe► SubscribeY► Subscribe
Santarus IncGLUMETZAmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005AB3RXYesYes► Subscribe► SubscribeYY► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-002Dec 21, 2004ABRXYesYes► Subscribe► Subscribe► Subscribe
Santarus IncGLUMETZAmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005AB3RXYesYes► Subscribe► SubscribeY► Subscribe
Santarus IncGLUMETZAmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005AB3RXYesYes► Subscribe► SubscribeYY► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-001Jun 15, 2004ABRXYesNo► Subscribe► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-002Dec 21, 2004ABRXYesYes► Subscribe► SubscribeYY► Subscribe
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Expired Patents for Santarus Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateCAPSULE;ORAL021849-002Feb 27, 2006► Subscribe► Subscribe
Santarus IncGLUMETZAmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateCAPSULE;ORAL021849-001Feb 27, 2006► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus IncZEGERIDomeprazole; sodium bicarbonateFOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
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Paragraph IV activity for SANTARUS INC drugs

Drugname Dosage Strength Tradename Submissiondate
fenofibrateTablets40 mg and 120 mgFENOGLIDE3/17/2010
metformin hydrochlorideExtended-release Tablets500 mg and 1000 mgGLUMETZA7/27/2009
omeprazole and sodium bicarbonatePowder for Oral Suspension20mg/1680mg per packetZEGERID11/13/2007
omeprazole and sodium bicarbonatePowder for Oral Suspension40 mg/1680 mg per packetZEGERID8/24/2007
omeprazole and sodium bicarbonateCapsules20 mg/1100 mg and 40 mg/1100 mgZEGERID4/30/2007

Non-Orange Book Patents for Santarus Inc

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,772,273Stabilized atorvastatin► Subscribe
8,158,147Modified release formulations of at least one form of tramadol► Subscribe
8,128,957Modified release compositions of at least one form of tramadol► Subscribe
2,005,182,056► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Santarus Inc Drugs

Country Document Number Estimated Expiration
European Patent Office1294363► Subscribe
Japan2010155864► Subscribe
MexicoPA04000223► Subscribe
South Korea20040047771► Subscribe
MexicoPA04006912► Subscribe
Poland201906► Subscribe
Austria256455► Subscribe
Japan2014133775► Subscribe
Australia2004279661► Subscribe
Germany69831335► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Santarus Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131/02Switzerland► SubscribePRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
C/GB11/015United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
C0028France► SubscribePRODUCT 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
/2012Austria► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
2012022Lithuania► SubscribePRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
2013 00001Denmark► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
00357Netherlands► SubscribePRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
/2008Austria► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Teva
Mallinckrodt
Healthtrust
Deloitte
US Department of Justice
Fuji
Federal Trade Commission
Cipla

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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