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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Chubb
Healthtrust
Federal Trade Commission
Baxter
Covington
Citi
Deloitte
Julphar
UBS

Generated: October 23, 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 thirty-two patent family members on NOVARTIS drugs in seventy-nine countries and three hundred and twenty-nine supplementary protection certificates in fifteen countries.

Summary for Applicant: Novartis

International Patents:3432
US Patents:193
Tradenames:194
Ingredients:163
NDAs:234
Drug Master File Entries: (click here to view)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
SIGNIFOR LAR
pasireotide pamoate
POWDER;INTRAMUSCULAR203255-002Dec 15, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Novartis
TEGRETOL-XR
carbamazepine
TABLET, EXTENDED RELEASE;ORAL020234-001Mar 25, 1996ABRXYesNo► Subscribe► Subscribe► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-001Oct 29, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
ALCAINE
proparacaine hydrochloride
SOLUTION/DROPS;OPHTHALMIC080027-001Approved Prior to Jan 1, 1982ATRXNoYes► Subscribe► Subscribe► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-001Oct 29, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis Pharms Corp
MAXIDEX
dexamethasone
SUSPENSION/DROPS;OPHTHALMIC013422-001Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-002May 29, 2013DISCNYesNo► Subscribe► Subscribe► Subscribe
Novartis
LAMISIL
terbinafine hydrochloride
GRANULE;ORAL022071-002Sep 28, 2007DISCNYesNo► Subscribe► Subscribe► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-002Nov 2, 2005ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Novartis

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
LOPRESSOR
metoprolol fumarate
TABLET, EXTENDED RELEASE;ORAL019786-003Dec 27, 1989► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
SOLUTION;ORAL050716-001Jul 14, 1995► Subscribe► Subscribe
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-005Apr 21, 2000► Subscribe► Subscribe
Novartis
LAMISIL
terbinafine hydrochloride
TABLET;ORAL020539-001May 10, 1996► Subscribe► Subscribe
Novartis
LAMISIL AT
terbinafine hydrochloride
SPRAY;TOPICAL021124-002Mar 17, 2000► Subscribe► Subscribe
Novartis Pharms Corp
EMADINE
emedastine difumarate
SOLUTION/DROPS;OPHTHALMIC020706-001Dec 29, 1997► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-009May 3, 2002► Subscribe► Subscribe
Novartis Pharms Corp
XTORO
finafloxacin
SUSPENSION/DROPS;OTIC206307-001Dec 17, 2014► Subscribe► Subscribe
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-003Nov 25, 1998► 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
famciclovir
Tablets125 mg, 250 mg and 500 mg
FAMVIR
12/28/2004
valsartan
Tablets40 mg, 80 mg,160 mg
DIOVAN
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
9,399,021Pharmaceutical composition► Subscribe
7,306,787Engineered particles and methods of use► Subscribe
8,580,806Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide► Subscribe
7,557,2102,4-pyrimidinediamine compounds and their uses► Subscribe
6,413,952 Agonizing dimeric cell-surface receptors with a receptor binding moiety and chelating metal► Subscribe
9,023,894Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► Subscribe
7,109,333Heterocyclic compounds► Subscribe
8,513,204Compositions comprising amphotericin B, mehods and systems► Subscribe
7,580,712Wireless high-speed data network planning tool► Subscribe
7,803,9392,4-pyrimidinediamine compounds and their uses► 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
Japan2014012747► Subscribe
Russian Federation2494727► Subscribe
Germany3430852► Subscribe
Japan4463380► Subscribe
Japan4012819► Subscribe
Japan5043308► Subscribe
World Intellectual Property Organization (WIPO)2009032694► Subscribe
China1158994► Subscribe
Japan2000351781► Subscribe
Slovenia2586426► 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
C/GB07/060United Kingdom► SubscribePRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822
C0036Belgium► SubscribePRODUCT NAME: FAMCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21325 19960708; FIRST REGISTRATION: GB - 10592/0035 19931210
C0030France► SubscribePRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
C/GB12/038United Kingdom► SubscribePRODUCT NAME: TRAVOPROST; REGISTERED: UK EU/1/01/199/001-002 20011129
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
90018-9Sweden► SubscribePRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
C0009Belgium► SubscribePRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
7Finland► Subscribe
2012 00018Denmark► SubscribePRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705
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
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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:

Covington
Johnson and Johnson
AstraZeneca
Novartis
Fish and Richardson
UBS
Mallinckrodt
Argus Health
Merck
McKesson

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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