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Serving leading biopharmaceutical companies globally:

Argus Health
Express Scripts
Colorcon
Mallinckrodt
US Army
Cerilliant
Healthtrust
UBS
AstraZeneca
Merck

Generated: October 24, 2017

DrugPatentWatch Database Preview

Sandoz Company Profile

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

SANDOZ has six hundred and ninety approved drugs.

There are two US patents protecting SANDOZ drugs on SANDOZ drugs in the past three years. There are twenty-eight tentative approvals on SANDOZ drugs.

There are twenty patent family members on SANDOZ drugs in eighteen countries and three hundred and twenty-five supplementary protection certificates in thirteen countries.

Summary for Applicant: Sandoz

International Patents:20
US Patents:2
Tradenames:385
Ingredients:358
NDAs:690
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
METHYCLOTHIAZIDE
methyclothiazide
TABLET;ORAL089837-001Aug 18, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz
IDARUBICIN HYDROCHLORIDE
idarubicin hydrochloride
INJECTABLE;INJECTION091293-001Mar 29, 2011DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
clindamycin phosphate
INJECTABLE;INJECTION201692-002May 31, 2012APRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochloride
TABLET;ORAL089586-002Oct 16, 1987ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
CEFPROZIL
cefprozil
TABLET;ORAL065235-002Nov 14, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
CITALOPRAM HYDROBROMIDE
citalopram hydrobromide
TABLET;ORAL077035-003Oct 28, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz
BETHANECHOL CHLORIDE
bethanechol chloride
TABLET;ORAL084384-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz
HYDROXYZINE PAMOATE
hydroxyzine pamoate
CAPSULE;ORAL086183-001Approved Prior to Jan 1, 1982ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
TERAZOSIN HYDROCHLORIDE
terazosin hydrochloride
CAPSULE;ORAL074823-004Mar 30, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
nitrofurantoin; nitrofurantoin, macrocrystalline
CAPSULE;ORAL077066-001Apr 5, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
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Paragraph IV activity for SANDOZ drugs

Drugname Dosage Strength Tradename Submissiondate
omeprazole
Delayed-release Tablets20 mg
OMEPRAZOLE
6/3/2015

Non-Orange Book Patents for Sandoz

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
6,261,547 Gelling ophthalmic compositions containing xanthan gum► 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 Sandoz Drugs

Country Document Number Estimated Expiration
Spain2203103► Subscribe
Australia740586► Subscribe
European Patent Office1069913► Subscribe
World Intellectual Property Organization (WIPO)9951273► Subscribe
Brazil9910113► Subscribe
TaiwanI262797► Subscribe
Denmark1069913► Subscribe
New Zealand506921► Subscribe
Hong Kong1031335► Subscribe
Germany69909768► 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 Sandoz Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
275Luxembourg► SubscribeCERTIFICATE TITLE: ENTECAVIR ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BARACLUDE); FIRST REGISTRATION: 20060626
2009004,C0770388Lithuania► SubscribePRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
C/GB08/005United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
C0012Belgium► SubscribePRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927
C/GB05/032United Kingdom► SubscribePRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322
70044Netherlands► SubscribePRODUCT NAME: CANDESARTAN, DESGENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF VAN DE 1-(CYCLOHEXYLOXYCARBONYLOXY) ETHYLESTE R, IN HET BIJZONDER CILEXETILI CANDESARTANAS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: RVG 21703 - RVG 21706 19971013; FIRST REGISTRATION: GB PL 15661/0001 - PL 15661/0004 19970429
2004002,C0734381Lithuania► SubscribePRODUCT NAME: 5-(((2R,3S)-2-((1R)-1-(3,5-BIS(TRIFLUORMETIL)FENIL)ETOKSI)-3-(4-FLUORFENIL)-4-MORFOLINIL)METIL)-1,2-DIHIDRO-3H-1,2,4-TRIAZOL-3-ONAS (APREPITANTAS); REGISTRATION NO/DATE: EU/1/03/262/001, 2003 11 11, EU/1/03/262/002, 2003 11 11, EU/1/03/262/003, 2003 11 11, EU/1/03/262/004, 2003 11 11, EU/1/03/262/005, 2003 11 11, EU/1/03/262/006 20031111
90022Netherlands► SubscribePRODUCT NAME: NEVIRAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION: CH 54393 19971223
41/2009Austria► SubscribePRODUCT NAME: PACLITAXEL ALBUMIN
90041Netherlands► SubscribePRODUCT NAME: DORZOLAMIDE, DESGEWENST IN DE VORM VAN EEN OFTALMOLOGISCH AAN- VAARDBAAR ZOUT, EN TIMOLOL, DESGEWENST IN DE VORM VAN EEN OFTAL -MOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER DORZOLLAMIDEHY- DROCHLORIDE EN TIMOLOLMALEAAT, EEN EN ANDER ZODANIG DAT 0,05; NATL REGISTRATION NO/DATE: VG 22871 19980805; FIRST REGISTRATION: DK 19045 19980306
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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:

US Department of Justice
Farmers Insurance
Argus Health
QuintilesIMS
Queensland Health
Accenture
Cantor Fitzgerald
UBS
Mallinckrodt
Medtronic

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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