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Serving 500+ biopharmaceutical companies globally:

Novartis
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Federal Trade Commission
Julphar
Teva
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Generated: August 16, 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-four patent family members on SANTARUS INC drugs in twenty-six countries.

Summary for Applicant: Santarus Inc

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 Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 2006ABRXYesYes► Subscribe► Subscribe ► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005AB3RXYesNo► Subscribe► SubscribeYY ► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004ABRXYesYes► Subscribe► Subscribe ► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004ABRXYesYes► Subscribe► Subscribe ► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005AB3RXYesNo► 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 Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 2006► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
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Paragraph IV activity for SANTARUS INC drugs

Drugname Dosage Strength Tradename Submissiondate
fenofibrate
Tablets40 mg and 120 mg
FENOGLIDE
3/17/2010
metformin hydrochloride
Extended-release Tablets500 mg and 1000 mg
GLUMETZA
7/27/2009
omeprazole and sodium bicarbonate
Powder for Oral Suspension20mg/1680mg per packet
ZEGERID
11/13/2007
omeprazole and sodium bicarbonate
Powder for Oral Suspension40 mg/1680 mg per packet
ZEGERID
8/24/2007
omeprazole and sodium bicarbonate
Capsules20 mg/1100 mg and 40 mg/1100 mg
ZEGERID
4/30/2007

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
8,128,957Modified release compositions of at least one form of tramadol► Subscribe
2,005,182,056► Subscribe
8,158,147Modified release formulations of at least one form of tramadol► 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
Japan2007508248► Subscribe
European Patent Office1927354► Subscribe
Russian Federation2343905► Subscribe
European Patent Office1246622► Subscribe
TaiwanI325326► 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
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
9 5017-2014Slovakia► SubscribePRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
2008000046Germany► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
/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
0677Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
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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 500+ biopharmaceutical companies globally:

Healthtrust
Argus Health
Federal Trade Commission
Cantor Fitzgerald
Harvard Business School
McKesson
Moodys
Accenture
QuintilesIMS
Farmers Insurance

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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