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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Moodys
Covington
Baxter
Fuji
Dow
Fish and Richardson
Cipla
US Department of Justice
Merck

Generated: November 20, 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-three US patents protecting NOVARTIS drugs and there have been eight Paragraph IV challenges on NOVARTIS drugs in the past three years.

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

Summary for Novartis

International Patents:3444
US Patents:193
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 Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
JADENU
deferasirox
TABLET;ORAL206910-003Mar 30, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Novartis
LUDIOMIL
maprotiline hydrochloride
TABLET;ORAL017543-003Sep 30, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-001Oct 29, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
ENTRESTO
sacubitril; valsartan
TABLET;ORAL207620-003Jul 7, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Novartis Pharms Corp
ENTRESTO
sacubitril; valsartan
TABLET;ORAL207620-001Jul 7, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-005Jun 20, 2007ABRXYesYes► Subscribe► SubscribeY► Subscribe
Novartis
AFINITOR
everolimus
TABLET;ORAL022334-002Mar 30, 2009RXYesYes► Subscribe► SubscribeY► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-006Aug 11, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Novartis Pharms Corp
KISQALI
ribociclib succinate
TABLET;ORAL209092-001Mar 13, 2017RXYesYes► Subscribe► Subscribe ► Subscribe
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Novartis

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-008Jan 8, 1999► Subscribe► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 2000► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-008Apr 21, 2011► Subscribe► Subscribe
Novartis
AFINITOR
everolimus
TABLET;ORAL022334-002Mar 30, 2009► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-001Jul 14, 1995► Subscribe► Subscribe
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-004Apr 21, 2000► Subscribe► Subscribe
Novartis
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL020364-005Jun 20, 2002► Subscribe► Subscribe
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 2013► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-001Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
SOLUTION;ORAL050716-001Jul 14, 1995► Subscribe► Subscribe
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Paragraph IV activity for NOVARTIS drugs

Drugname Dosage Strength Tradename Submissiondate
everolimus
Tablets for Oral Suspension2 mg, 3 mg and 5 mg
AFINITOR DISPERZ
12/30/2016
deferasirox
Tablets180 mg
JADENU
4/28/2016
travoprost
Ophthalmic Solution0.003%
IZBA
12/30/2015
nepafenac
Ophthalmic Suspension0.3%
ILEVRO
12/21/2015
deferasirox
Tablets180 mg
JADENU
10/23/2015
deferasirox
Tablets90 mg and 360 mg
JADENU
10/19/2015
olopatadine hydrochloride
Ophthalmic Solution0.7%
PAZEO
9/10/2015
everolimus
Tablets2.5 mg, 5 mg, and 7.5 mg
AFINITOR
12/10/2014
fingolimod
Capsules0.5 mg
GILENYA
9/22/2014
everolimus
Tablets10 mg
AFINITOR
6/18/2014
difluprednate
Ophthalmic Emulsion0.05%
DUREZOL
5/1/2014
eltrombopag olamine
Tablets12.5 mg and 25 mg
PROMACTA
2/4/2014
imatinib mesylate
Capsules400 mg
GLEEVEC
1/24/2014
eltrombopag olamine
Tablets50 mg and 75 mg
PROMACTA
1/7/2014
everolimus
Tablets0.25 mg, 0.5 mg, and 0.75 mg
ZORTRESS
9/30/2013
nilotinib
Capsules150 mg and 200 mg
TASIGNA
1/29/2013
rivastigmine
Transdermal System Extended-release13.3 mg/24 hr
EXELON
1/22/2013
ciprofloxacin and dexamethasone
Otic Suspension0.3%/0.1%
CIPRODEX
7/31/2012
moxifloxacin hydrochloride
Ophthalmic Solution10.5%
MOXEZA
2/29/2012
zoledronic acid
Injection4 mg/100 mg, 100 mL vial
ZOMETA
1/31/2012
argatroban in sodium chloride
Injection1 mg/mL, 50 mL vials
ARGATROBAN
12/16/2011
deferasirox
Tablets125 mg, 250 mg, and 500 mg
EXJADE
10/28/2011
dexmethylphenidate
Extended-release capsules25 mg
FOCALIN XR
9/30/2011
dexmethylphenidate
Extended-release capsules35 mg
FOCALIN XR
9/29/2011
lapatinib ditosylate
Tablets250 mg
TYKERB
3/14/2011
dexmethyphenidate hydrochloride
Extended-release Capsule40 mg
FOCALIN XR
12/20/2010
dexmethylphenidate hydrochloride
Extended-release Capsule30 mg
FOCALIN XR
12/15/2010
amlodipine, hydrochlorothiazide and valsartan
Tablets10 mg/12.5 mg/160 mg
EXFORGE HCT
10/22/2009
amlodipine, hydrochlorothiazide and valsartan
Tablets5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 m
EXFORGE HCT
9/14/2009
olopatadine hydrochloride
Nasal Spray0.665 mg/ Spray
PATANASE
6/29/2009
tobramycin
Inhalation Solution300 mg/5 mL
TOBI
6/29/2009
mycophenolic acid
Delayed-release Tablets180 mg
MYFORTIC
6/4/2009
travoprost (preserved)
Ophthalmic Solution0.00%
TRAVATAN Z
2/19/2009
mycophenolic acid
Delayed-release Tablets360 mg
MYFORTIC
2/2/2009
olopatadine hydrochloride
Ophthalmic Solution0.20%
PATADAY
9/8/2008
zoledronic acid
Injection0.05 mg/mL, 100 mL vial
RECLAST
8/29/2008
zoledronic acid
Injection0.8 mg (base) /mL
ZOMETA
6/11/2008
fluvastatin
Capsules20 mg and 40 mg
LESCOL
6/4/2008
amlodipine besylate and valsartan
Tablets5 mg/320 mg
EXFORGE
11/26/2007
amlodipine besylate and valsartan
Tablets10 mg/320 mg
EXFORGE
11/9/2007
amlodipine besylate and valsartan
Tablets5 mg/160 mg
EXFORGE
10/22/2007
amlodipine besylate and valsartan
Tablets10 mg/160 mg
EXFORGE
10/1/2007
argatroban
Injection100 mg/mL, 2.5 mL vials
ARGATROBAN
9/24/2007
metformin hydrochloride
Extended-release Capsules10 mg
RITALIN LA
5/21/2007
dexmethylphenidate hydrochloride
Extended-release Capsules15 mg
FOCALIN XR
5/14/2007
dexmethylphenidate hydrochloride
Extended-release Capsules5mg, 10mg and 20 mg
FOCALIN XR
3/30/2007
fluvastatin sodium
Extended-release Tablets80 mg
LESCOL XL
3/15/2007
imatinib mesylate
Tablets100 mg and 400 mg
GLEEVEC
3/12/2007
valsartan and hydrochlorothiazide
Tablets320 mg/12.5 mg and 320 mg/25 mg
DIOVAN HCT
2/7/2007
oxcarbazepine
Oral Suspension300 mg/5 mL
TRILEPTAL
12/26/2006
amlodipine besylate and benazepril hydrochloride
Capsules5 mg/40 mg and 10 mg/40 mg
LOTREL
11/17/2006
metformin hydrochloride
Extended-release Capsules20 mg, 30 mg and 40 mg
RITALIN LA
8/21/2006
olopatadine hydrochloride
Ophthalmic Solution0.10%
PATANOL
7/17/2006
oxcarbazepine
Tablets150 mg, 300 mg and 600 mg
TRILEPTAL
5/5/2006
letrozole
Tablets2.5 mg
FEMARA
3/2/2006
carbamazepine
Extended-release Tablets100 mg
TEGRETOL-XR
12/30/2005
moxifloxacin hydrochloride
Ophthalmic0.50%
VIGAMOX
12/22/2005
valsartan and hydrochlorothiazide
Tablets80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg
DIOVAN HCT
12/2/2005
valsartan
Tablets40 mg, 80 mg,160 mg
DIOVAN
12/28/2004
famciclovir
Tablets125 mg, 250 mg and 500 mg
FAMVIR
12/28/2004
nateglinide
Tablets60 mg and 120 mg
STARLIX
12/22/2004
ondansetron hydrochloride
Oral Solution4 mg/5 mL
ZOFRAN
12/20/2004
rivastigmine tartrate
Oral Solution2 mg/mL
EXELON
11/5/2004
dexmethylphenidate hydrochloride
Tablets2.5 mg
FOCALIN
7/27/2004
amlodipine besylate and benazepril hydrochloride
Capsules2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg
LOTREL
6/9/2004
dexmethylphenidate hydrochloride
Tablets5 mg and 10 mg
FOCALIN
5/27/2004
rivastigmine tartrate
Capsules1.5 mg, 3 mg, 4.5 mg and 6 mg
EXELON
4/21/2004

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
5,539,098 5'-O-propionyl and 5'-O-butyryl esters of 2-amino-6-methoxy-9-(.beta.-D-arabinofuranosyl)-9H-purine► Subscribe
9,023,893Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► Subscribe
7,655,797Intermediates for making 2,4-pyrimidinediamine compounds► Subscribe
9,035,021Somatostatin analogues► Subscribe
8,741,963S1P receptor modulators for treating multiple sclerosis► Subscribe
8,829,015Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide► Subscribe
5,719,176 2-amino-1,3-propanediol compound and immunosuppressant► Subscribe
7,803,9392,4-pyrimidinediamine compounds and their uses► Subscribe
7,628,978Stabilized preparations for use in metered dose inhalers► Subscribe
7,905,230Metered dose inhaler with lockout► 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
Portugal1471915► Subscribe
Tunisia2009000225► Subscribe
Russian Federation2358739► Subscribe
Norway20090119► Subscribe
European Patent Office2488033► Subscribe
Canada2662571► Subscribe
Australia2017203897► Subscribe
San MarinoT201500300► Subscribe
South Africa9801205► Subscribe
Japan5718929► 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
174Luxembourg► SubscribePRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI
C/GB96/057United Kingdom► SubscribePRODUCT NAME: TOPOTECAN; REGISTERED: CH IKS-NR:53857 19961016; UK EU/1/96/027/001 19961112; UK EU/1/96/027/002 19961112
2012017,C1920764Lithuania► 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
90015-6Sweden► SubscribePRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
00716Netherlands► SubscribePRODUCT NAME: PASIREOTIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/753 20141119
C/GB03/004United Kingdom► SubscribePRODUCT NAME: BRINZOLAMIDE; REGISTERED: CH IKS 55236 19991217; UK EU/1/00/129/01 20000309; UK EU/1/00/129/02 20000309
12/033Ireland► SubscribePRODUCT NAME: TRAVOPROST (ALSO CALLED FLUPROSTENOL ISOPROPYL ESTER); NAT REGISTRATION NO/DATE: EU/1/01/199/001-002 20011129; FIRST REGISTRATION NO/DATE: EU/1/01/199/001-002 20011129; PAEDIATRIC INVESTIGATION PLAN: P/0298/2013 PROCEEDINGS UNDER SECTION 37 OF THE PATENTS ACT, 1992 RESTORATION ORDER DATED 12TH JANUARY 2016, WAS MADE RESTORING THE PATENT MENTIONED BELOW S85583 PAUL DOYLE A RE-USABLE BAG SYSTEM RESTORATION ORDERS DATED 16TH FEBRUARY 2016, WERE MADE RESTORING THE PATENTS MENTIONED BELOW S86133 MERVYN GREENE MULTI PURPOSE TANK STAND WITH COMPLEX LOCKING MECHANISM 86119 MPC GREEN LIMITED ANEW BIN
90022-1Sweden► SubscribePRODUCT NAME: PASIREOTID; REG. NO/DATE: EU/1/12/753/001 20120424
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
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
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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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
Baxter
Fish and Richardson
Cipla
Healthtrust
Chinese Patent Office
Queensland Health
Dow
Boehringer Ingelheim
Accenture

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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ISSN: 2162-2639

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