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Serving leading biopharmaceutical companies globally:

Citi
Moodys
McKinsey
Daiichi Sankyo
US Army
Covington
Medtronic
Federal Trade Commission
Farmers Insurance
Express Scripts

Generated: December 13, 2017

DrugPatentWatch Database Preview

Novartis Company Profile

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What is the competitive landscape for NOVARTIS, and when can generic versions of NOVARTIS drugs launch?

NOVARTIS has two hundred and thirty-four approved drugs.

There are one hundred and ninety-four US patents protecting NOVARTIS drugs and there have been seven Paragraph IV challenges on NOVARTIS drugs in the past three years.

There are three thousand four hundred and eighty-five patent family members on NOVARTIS drugs in eighty countries and three hundred and thirty-five supplementary protection certificates in fifteen countries.

Summary for Novartis

International Patents:3485
US Patents:194
Tradenames:194
Ingredients:163
NDAs:234
Drug Master File Entries: 1
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
NovartisSERPASILreserpineTABLET;ORAL009115-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-001Jun 5, 2002AB1RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisFOCALINdexmethylphenidate hydrochlorideTABLET;ORAL021278-003Nov 13, 2001ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Novartis PharmAFINITOR DISPERZeverolimusTABLET, FOR SUSPENSION;ORAL203985-002Aug 29, 2012RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpENTRESTOsacubitril; valsartanTABLET;ORAL207620-002Jul 7, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisEXFORGEamlodipine besylate; valsartanTABLET;ORAL021990-002Jun 20, 2007ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisREGITINEphentolamine mesylateINJECTABLE;INJECTION008278-003Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpRYDAPTmidostaurinCAPSULE;ORAL207997-001Apr 28, 2017RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-003Jul 9, 2010RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpPROMACTAeltrombopag olamineTABLET;ORAL022291-005Nov 16, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Novartis

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms CorpZOFRAN ODTondansetronTABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 1999► Subscribe► Subscribe
NovartisFOCALIN XRdexmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005► Subscribe► Subscribe
NovartisFOCALIN XRdexmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005► Subscribe► Subscribe
NovartisCYTADRENaminoglutethimideTABLET;ORAL018202-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Novartis Pharms CorpZOFRANondansetron hydrochlorideTABLET;ORAL020103-002Dec 31, 1992► Subscribe► Subscribe
NovartisLAMISIL ATterbinafineGEL;TOPICAL021958-001Jul 24, 2006► Subscribe► Subscribe
Novartis Pharms CorpCIPRO HCciprofloxacin hydrochloride; hydrocortisoneSUSPENSION/DROPS;OTIC020805-001Feb 10, 1998► Subscribe► Subscribe
NovartisTEGRETOLcarbamazepineTABLET;ORAL016608-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Novartis Pharms CorpCILOXANciprofloxacin hydrochlorideSOLUTION/DROPS;OPHTHALMIC019992-001Dec 31, 1990► Subscribe► Subscribe
NovartisFOCALINdexmethylphenidate hydrochlorideTABLET;ORAL021278-003Nov 13, 2001► Subscribe► Subscribe
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Paragraph IV activity for NOVARTIS drugs

Drugname Dosage Strength Tradename Submissiondate
everolimusTablets for Oral Suspension2 mg, 3 mg and 5 mgAFINITOR DISPERZ12/30/2016
deferasiroxTablets180 mgJADENU4/28/2016
travoprostOphthalmic Solution0.003%IZBA12/30/2015
nepafenacOphthalmic Suspension0.3%ILEVRO12/21/2015
deferasiroxTablets180 mgJADENU10/23/2015
deferasiroxTablets90 mg and 360 mgJADENU10/19/2015
olopatadine hydrochlorideOphthalmic Solution0.7%PAZEO9/10/2015
everolimusTablets2.5 mg, 5 mg, and 7.5 mgAFINITOR12/10/2014
fingolimodCapsules0.5 mgGILENYA9/22/2014
everolimusTablets10 mgAFINITOR6/18/2014
difluprednateOphthalmic Emulsion0.05%DUREZOL5/1/2014
eltrombopag olamineTablets12.5 mg and 25 mgPROMACTA2/4/2014
imatinib mesylateCapsules400 mgGLEEVEC1/24/2014
eltrombopag olamineTablets50 mg and 75 mgPROMACTA1/7/2014
everolimusTablets0.25 mg, 0.5 mg, and 0.75 mgZORTRESS9/30/2013
nilotinibCapsules150 mg and 200 mgTASIGNA1/29/2013
rivastigmineTransdermal System Extended-release13.3 mg/24 hrEXELON1/22/2013
ciprofloxacin and dexamethasoneOtic Suspension0.3%/0.1%CIPRODEX7/31/2012
moxifloxacin hydrochlorideOphthalmic Solution10.5%MOXEZA2/29/2012
zoledronic acidInjection4 mg/100 mg, 100 mL vialZOMETA1/31/2012
argatroban in sodium chlorideInjection1 mg/mL, 50 mL vialsARGATROBAN12/16/2011
deferasiroxTablets125 mg, 250 mg, and 500 mgEXJADE10/28/2011
dexmethylphenidateExtended-release capsules25 mgFOCALIN XR9/30/2011
dexmethylphenidateExtended-release capsules35 mgFOCALIN XR9/29/2011
lapatinib ditosylateTablets250 mgTYKERB3/14/2011
dexmethyphenidate hydrochlorideExtended-release Capsule40 mgFOCALIN XR12/20/2010
dexmethylphenidate hydrochlorideExtended-release Capsule30 mgFOCALIN XR12/15/2010
amlodipine, hydrochlorothiazide and valsartanTablets10 mg/12.5 mg/160 mgEXFORGE HCT10/22/2009
amlodipine, hydrochlorothiazide and valsartanTablets5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mEXFORGE HCT9/14/2009
olopatadine hydrochlorideNasal Spray0.665 mg/ SprayPATANASE6/29/2009
tobramycinInhalation Solution300 mg/5 mLTOBI6/29/2009
mycophenolic acidDelayed-release Tablets180 mgMYFORTIC6/4/2009
travoprost (preserved)Ophthalmic Solution0.00%TRAVATAN Z2/19/2009
mycophenolic acidDelayed-release Tablets360 mgMYFORTIC2/2/2009
olopatadine hydrochlorideOphthalmic Solution0.20%PATADAY9/8/2008
zoledronic acidInjection0.05 mg/mL, 100 mL vialRECLAST8/29/2008
zoledronic acidInjection0.8 mg (base) /mLZOMETA6/11/2008
fluvastatinCapsules20 mg and 40 mgLESCOL6/4/2008
amlodipine besylate and valsartanTablets5 mg/320 mgEXFORGE11/26/2007
amlodipine besylate and valsartanTablets10 mg/320 mgEXFORGE11/9/2007
amlodipine besylate and valsartanTablets5 mg/160 mgEXFORGE10/22/2007
amlodipine besylate and valsartanTablets10 mg/160 mgEXFORGE10/1/2007
argatrobanInjection100 mg/mL, 2.5 mL vialsARGATROBAN9/24/2007
metformin hydrochlorideExtended-release Capsules10 mgRITALIN LA5/21/2007
dexmethylphenidate hydrochlorideExtended-release Capsules15 mgFOCALIN XR5/14/2007
dexmethylphenidate hydrochlorideExtended-release Capsules5mg, 10mg and 20 mgFOCALIN XR3/30/2007
fluvastatin sodiumExtended-release Tablets80 mgLESCOL XL3/15/2007
imatinib mesylateTablets100 mg and 400 mgGLEEVEC3/12/2007
valsartan and hydrochlorothiazideTablets320 mg/12.5 mg and 320 mg/25 mgDIOVAN HCT2/7/2007
oxcarbazepineOral Suspension300 mg/5 mLTRILEPTAL12/26/2006
amlodipine besylate and benazepril hydrochlorideCapsules5 mg/40 mg and 10 mg/40 mgLOTREL11/17/2006
metformin hydrochlorideExtended-release Capsules20 mg, 30 mg and 40 mgRITALIN LA8/21/2006
olopatadine hydrochlorideOphthalmic Solution0.10%PATANOL7/17/2006
oxcarbazepineTablets150 mg, 300 mg and 600 mgTRILEPTAL5/5/2006
letrozoleTablets2.5 mgFEMARA3/2/2006
carbamazepineExtended-release Tablets100 mgTEGRETOL-XR12/30/2005
moxifloxacin hydrochlorideOphthalmic0.50%VIGAMOX12/22/2005
valsartan and hydrochlorothiazideTablets80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mgDIOVAN HCT12/2/2005
valsartanTablets40 mg, 80 mg,160 mgDIOVAN12/28/2004
famciclovirTablets125 mg, 250 mg and 500 mgFAMVIR12/28/2004
nateglinideTablets60 mg and 120 mgSTARLIX12/22/2004
ondansetron hydrochlorideOral Solution4 mg/5 mLZOFRAN12/20/2004
rivastigmine tartrateOral Solution2 mg/mLEXELON11/5/2004
dexmethylphenidate hydrochlorideTablets2.5 mgFOCALIN7/27/2004
amlodipine besylate and benazepril hydrochlorideCapsules2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mgLOTREL6/9/2004
dexmethylphenidate hydrochlorideTablets5 mg and 10 mgFOCALIN5/27/2004
rivastigmine tartrateCapsules1.5 mg, 3 mg, 4.5 mg and 6 mgEXELON4/21/2004

Premature patent expirations for NOVARTIS

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book Patents for Novartis

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
7,326,691Compositions comprising amphotericin B, methods, and systems► Subscribe
7,473,433Pulmonary delivery of polyene antifungal agents► Subscribe
6,793,936 Multiparticulate modified release composition► Subscribe
8,440,6812-biphenylamino-4-aminopyrimidine derivatives as kinase inhibitors► Subscribe
9,162,9892,4-Pyrimidinediamine compounds and their uses► Subscribe
8,957,081Compounds and compositions as protein kinase inhibitors► Subscribe
6,296,872 Tablet composition of N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine► Subscribe
7,498,4352,4-pyrimidinediamine compounds and their uses► Subscribe
7,205,343Stabilized bioactive preparations and method of use► Subscribe
8,567,893Print signal generation system► 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 Novartis Drugs

Country Document Number Estimated Expiration
Canada2671744► Subscribe
BrazilPI0717093► Subscribe
Portugal2670401► Subscribe
European Patent Office2275413► Subscribe
Slovakia7432002► Subscribe
World Intellectual Property Organization (WIPO)2010020675► Subscribe
Germany69740161► Subscribe
South Korea20160144507► Subscribe
Georgia, Republic ofP20135785► Subscribe
Russian Federation2352572► 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 Novartis Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012017Lithuania► SubscribePRODUCT NAME: TRAVOPROSTUM; NAT. REGISTRATION NO/DATE: LT 02/7821/3 20020402; FIRST REGISTRATION: EU/1/01/199/001 - EU/1/01/199/002 20011127
02/005Ireland► SubscribePRODUCT NAME: IMATINIB OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; NAT REGISTRATION NO/DATE: EU/1/01/198/001-006 20011107; FIRST REGISTRATION NO/DATE: CH 55807 55807 01 55807 02 20010621; PAEDIATRIC INVESTIGATION PLAN: P/0028/2012
678Luxembourg► SubscribePRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
C0030France► SubscribePRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
00445Netherlands► SubscribePRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
49/2008Austria► SubscribePRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
C0063France► SubscribePRODUCT NAME: COMBINAISON COMPRENANT DE L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET DE L'ALMODIPINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/686/001 20110414
00488Netherlands► SubscribePRODUCT NAME: FINGOLIMOD, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
C/GB11/010United Kingdom► SubscribePRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
C/GB12/030United Kingdom► SubscribePRODUCT NAME: CYCLO((4R)-4-(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-)), PASIREOTIDE, OR SALTS THEREOF; REGISTERED: UK EU/1/12/753/001-012 20120424
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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:

Federal Trade Commission
Harvard Business School
Queensland Health
Healthtrust
Farmers Insurance
McKinsey
QuintilesIMS
UBS
Chubb
Argus Health

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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