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Generated: September 24, 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 seven Paragraph IV challenges on NOVARTIS drugs in the past three years.

There are three thousand four hundred and seventeen patent family members on NOVARTIS drugs in seventy-nine countries.

Summary for Applicant: Novartis

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
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis Pharms Corp
KISQALI
ribociclib succinate
TABLET;ORAL209092-001Mar 13, 2017RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis
METANDREN
methyltestosterone
TABLET;BUCCAL, SUBLINGUAL003240-004Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
TOBREX
tobramycin
OINTMENT;OPHTHALMIC050555-001Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
JADENU SPRINKLE
deferasirox
GRANULE;ORAL207968-001May 18, 2017RXYesNo► Subscribe► SubscribeYY ► Subscribe
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-001Apr 30, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Novartis
AFINITOR
everolimus
TABLET;ORAL022334-001Mar 30, 2009RXYesNo► Subscribe► Subscribe► Subscribe
Novartis Pharm
AFINITOR DISPERZ
everolimus
TABLET, FOR SUSPENSION;ORAL203985-002Aug 29, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Novartis
LAMISIL
terbinafine hydrochloride
GRANULE;ORAL022071-001Sep 28, 2007DISCNYesNo► Subscribe► Subscribe► Subscribe
Novartis
RITALIN
methylphenidate hydrochloride
TABLET;ORAL010187-010Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Novartis

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 1999► Subscribe► Subscribe
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010► Subscribe► Subscribe
Novartis
RITALIN LA
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021284-004Apr 10, 2004► Subscribe► Subscribe
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-004Oct 28, 1994► Subscribe► Subscribe
Novartis Pharms Corp
XTORO
finafloxacin
SUSPENSION/DROPS;OTIC206307-001Dec 17, 2014► Subscribe► Subscribe
Novartis
TEGRETOL-XR
carbamazepine
TABLET, EXTENDED RELEASE;ORAL020234-001Mar 25, 1996► Subscribe► Subscribe
Novartis
TEGRETOL-XR
carbamazepine
TABLET, EXTENDED RELEASE;ORAL020234-002Mar 25, 1996► Subscribe► Subscribe
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-003Nov 25, 1998► Subscribe► Subscribe
Novartis Pharms Corp
HYCAMTIN
topotecan hydrochloride
CAPSULE;ORAL020981-001Oct 11, 2007► Subscribe► Subscribe
Novartis Pharms Corp
TYKERB
lapatinib ditosylate
TABLET;ORAL022059-001Mar 13, 2007► 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
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
9,040,5502,4-pyrimidinediamine compounds and their uses► Subscribe
7,572,804Macrolides► Subscribe
7,323,451Crystalline and amorphous forms of beta-L-2'-deoxythymidine► Subscribe
9,499,4932,4-pyrimidinediamine compounds and their uses► Subscribe
7,956,053Inhibitors of tyrosine kinases► Subscribe
8,088,8133'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)► Subscribe
7,326,691Compositions comprising amphotericin B, methods, and systems► Subscribe
5,719,176 2-amino-1,3-propanediol compound and immunosuppressant► Subscribe
7,485,7242,4-pyrimidinediamine compounds and their uses► Subscribe
6,486,138 Ophthalmic compositions containing galactomannan polymers and borate► 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
Argentina084309► Subscribe
Argentina047310► Subscribe
Poland372369► Subscribe
World Intellectual Property Organization (WIPO)2004073708► Subscribe
South Africa200710000► Subscribe
Germany602004025271► Subscribe
China1655819► Subscribe
Russian Federation2015126799► Subscribe
MexicoPA03000991► Subscribe
HungaryE028204► 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
0100006 00032Estonia► SubscribePRODUCT NAME: REVOLADE-ELTROMBOPAG; REG NO/DATE: C(2010)1662 11.03.2010
2011 00026Denmark► SubscribePRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
2009Austria► SubscribePRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
11/2009Austria► SubscribePRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON
2013000085Germany► SubscribePRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
8Finland► Subscribe
2016003Lithuania► SubscribePRODUCT NAME: PANOBINOSTATAS; REGISTRATION NO/DATE: EU/1/15/1023 20120828
C0036Belgium► SubscribePRODUCT NAME: FAMCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21325 19960708; FIRST REGISTRATION: GB - 10592/0035 19931210
/2009Austria► SubscribePRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028
0248Netherlands► Subscribe300248, 20170624, EXPIRES: 20210827
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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 500+ biopharmaceutical companies globally:

Deloitte
Baxter
Accenture
McKinsey
Chubb
US Department of Justice
Boehringer Ingelheim
Moodys
QuintilesIMS
Fish and Richardson

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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