BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Merck
Farmers Insurance
Fuji
Covington
Boehringer Ingelheim
Federal Trade Commission
Accenture
US Army
Dow
QuintilesIMS

Generated: January 23, 2018

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-seven patent family members on NOVARTIS drugs in eighty countries and three hundred and forty supplementary protection certificates in fifteen countries.

Summary for Novartis
International Patents:3487
US Patents:194
Tradenames:194
Ingredients:163
NDAs:234
Drug Master File Entries: 1

Drugs and US Patents for Novartis

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis Pharms Corp ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-003 Apr 30, 2009 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis Pharms Corp MYDRIACYL tropicamide SOLUTION/DROPS;OPHTHALMIC 084306-001 Approved Prior to Jan 1, 1982 AT RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis Pharms Corp DUREZOL difluprednate EMULSION;OPHTHALMIC 022212-001 Jun 23, 2008 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis BUTAZOLIDIN phenylbutazone TABLET;ORAL 008319-008 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis FAMVIR famciclovir TABLET;ORAL 020363-001 Apr 26, 1996 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-003 Jun 20, 2007 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Novartis

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 ➤ Subscribe ➤ Subscribe
Novartis LIVOSTIN levocabastine hydrochloride SUSPENSION/DROPS;OPHTHALMIC 020219-001 Nov 10, 1993 ➤ Subscribe ➤ Subscribe
Novartis TRASICOR oxprenolol hydrochloride CAPSULE;ORAL 018166-002 Dec 28, 1983 ➤ Subscribe ➤ Subscribe
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-002 Jul 14, 1995 ➤ Subscribe ➤ Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-004 Feb 27, 1996 ➤ Subscribe ➤ Subscribe
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 ➤ Subscribe ➤ Subscribe
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-002 Nov 13, 2001 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp CILOXAN ciprofloxacin hydrochloride OINTMENT;OPHTHALMIC 020369-001 Mar 30, 1998 ➤ Subscribe ➤ Subscribe
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-001 Oct 21, 1988 ➤ Subscribe ➤ Subscribe
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-003 Nov 25, 1998 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for NOVARTIS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets for Oral Suspension 2 mg, 3 mg and 5 mg ➤ Subscribe 12/30/2016
➤ Subscribe Tablets 180 mg ➤ Subscribe 4/28/2016
➤ Subscribe Ophthalmic Solution 0.003% ➤ Subscribe 12/30/2015
➤ Subscribe Ophthalmic Suspension 0.3% ➤ Subscribe 12/21/2015
➤ Subscribe Tablets 180 mg ➤ Subscribe 10/23/2015
➤ Subscribe Tablets 90 mg and 360 mg ➤ Subscribe 10/19/2015
➤ Subscribe Ophthalmic Solution 0.7% ➤ Subscribe 9/10/2015
➤ Subscribe Tablets 2.5 mg, 5 mg, and 7.5 mg ➤ Subscribe 12/10/2014
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 9/22/2014
➤ Subscribe Tablets 10 mg ➤ Subscribe 6/18/2014
➤ Subscribe Ophthalmic Emulsion 0.05% ➤ Subscribe 5/1/2014
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe 2/4/2014
➤ Subscribe Capsules 400 mg ➤ Subscribe 1/24/2014
➤ Subscribe Tablets 50 mg and 75 mg ➤ Subscribe 1/7/2014
➤ Subscribe Tablets 0.25 mg, 0.5 mg, and 0.75 mg ➤ Subscribe 9/30/2013
➤ Subscribe Capsules 150 mg and 200 mg ➤ Subscribe 1/29/2013
➤ Subscribe Transdermal System Extended-release 13.3 mg/24 hr ➤ Subscribe 1/22/2013
➤ Subscribe Otic Suspension 0.3%/0.1% ➤ Subscribe 7/31/2012
➤ Subscribe Ophthalmic Solution 10.5% ➤ Subscribe 2/29/2012
➤ Subscribe Injection 4 mg/100 mg, 100 mL vial ➤ Subscribe 1/31/2012
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 12/16/2011
➤ Subscribe Tablets 125 mg, 250 mg, and 500 mg ➤ Subscribe 10/28/2011
➤ Subscribe Extended-release capsules 25 mg ➤ Subscribe 9/30/2011
➤ Subscribe Extended-release capsules 35 mg ➤ Subscribe 9/29/2011
➤ Subscribe Tablets 250 mg ➤ Subscribe 3/14/2011
➤ Subscribe Extended-release Capsule 40 mg ➤ Subscribe 12/20/2010
➤ Subscribe Extended-release Capsule 30 mg ➤ Subscribe 12/15/2010
➤ Subscribe Tablets 10 mg/12.5 mg/160 mg ➤ Subscribe 10/22/2009
➤ Subscribe Tablets 5 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 ➤ Subscribe 9/14/2009
➤ Subscribe Nasal Spray 0.665 mg/ Spray ➤ Subscribe 6/29/2009
➤ Subscribe Inhalation Solution 300 mg/5 mL ➤ Subscribe 6/29/2009
➤ Subscribe Delayed-release Tablets 180 mg ➤ Subscribe 6/4/2009
➤ Subscribe Ophthalmic Solution 0.00% ➤ Subscribe 2/19/2009
➤ Subscribe Delayed-release Tablets 360 mg ➤ Subscribe 2/2/2009
➤ Subscribe Ophthalmic Solution 0.20% ➤ Subscribe 9/8/2008
➤ Subscribe Injection 0.05 mg/mL, 100 mL vial ➤ Subscribe 8/29/2008
➤ Subscribe Injection 0.8 mg (base) /mL ➤ Subscribe 6/11/2008
➤ Subscribe Capsules 20 mg and 40 mg ➤ Subscribe 6/4/2008
➤ Subscribe Tablets 5 mg/320 mg ➤ Subscribe 11/26/2007
➤ Subscribe Tablets 10 mg/320 mg ➤ Subscribe 11/9/2007
➤ Subscribe Tablets 5 mg/160 mg ➤ Subscribe 10/22/2007
➤ Subscribe Tablets 10 mg/160 mg ➤ Subscribe 10/1/2007
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 9/24/2007
➤ Subscribe Extended-release Capsules 10 mg ➤ Subscribe 5/21/2007
➤ Subscribe Extended-release Capsules 15 mg ➤ Subscribe 5/14/2007
➤ Subscribe Extended-release Capsules 5mg, 10mg and 20 mg ➤ Subscribe 3/30/2007
➤ Subscribe Extended-release Tablets 80 mg ➤ Subscribe 3/15/2007
➤ Subscribe Tablets 100 mg and 400 mg ➤ Subscribe 3/12/2007
➤ Subscribe Tablets 320 mg/12.5 mg and 320 mg/25 mg ➤ Subscribe 2/7/2007
➤ Subscribe Oral Suspension 300 mg/5 mL ➤ Subscribe 12/26/2006
➤ Subscribe Capsules 5 mg/40 mg and 10 mg/40 mg ➤ Subscribe 11/17/2006
➤ Subscribe Extended-release Capsules 20 mg, 30 mg and 40 mg ➤ Subscribe 8/21/2006
➤ Subscribe Ophthalmic Solution 0.10% ➤ Subscribe 7/17/2006
➤ Subscribe Tablets 150 mg, 300 mg and 600 mg ➤ Subscribe 5/5/2006
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 3/2/2006
➤ Subscribe Extended-release Tablets 100 mg ➤ Subscribe 12/30/2005
➤ Subscribe Ophthalmic 0.50% ➤ Subscribe 12/22/2005
➤ Subscribe Tablets 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg ➤ Subscribe 12/2/2005
➤ Subscribe Tablets 40 mg, 80 mg,160 mg ➤ Subscribe 12/28/2004
➤ Subscribe Tablets 125 mg, 250 mg and 500 mg ➤ Subscribe 12/28/2004
➤ Subscribe Tablets 60 mg and 120 mg ➤ Subscribe 12/22/2004
➤ Subscribe Oral Solution 4 mg/5 mL ➤ Subscribe 12/20/2004
➤ Subscribe Oral Solution 2 mg/mL ➤ Subscribe 11/5/2004
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 7/27/2004
➤ Subscribe Capsules 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg ➤ Subscribe 6/9/2004
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 5/27/2004
➤ Subscribe Capsules 1.5 mg, 3 mg, 4.5 mg and 6 mg ➤ Subscribe 4/21/2004
Premature patent expirations for NOVARTIS

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
➤ Subscribe ➤ Subscribe
➤ Subscribe ➤ Subscribe

Non-Orange Book US 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
7,439,342 Thrombopoietin mimetics ➤ Subscribe
5,977,160 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims ➤ Subscribe
8,168,223 Engineered particles and methods of use ➤ Subscribe
7,905,230 Metered dose inhaler with lockout ➤ Subscribe
7,517,886 Methods of treating or preventing autoimmune diseases with 2,4-pyrimidinediamine compounds ➤ Subscribe
7,329,672 2,4-pyrimidinediamine compounds and their uses ➤ Subscribe
7,569,566 Inhibitors of tyrosine kinases ➤ Subscribe
9,035,021 Somatostatin analogues ➤ Subscribe
7,473,433 Pulmonary delivery of polyene antifungal agents ➤ Subscribe
8,513,204 Compositions comprising amphotericin B, mehods and systems ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for Novartis Drugs

Supplementary Protection Certificates for Novartis Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90054-1 Sweden ➤ Subscribe PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/15/999 20150508
90048-3 Sweden ➤ Subscribe PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/999 20150508
0716600/01 Switzerland ➤ Subscribe PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
C0064 France ➤ Subscribe PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/999 20150508
C/GB10/026 United Kingdom ➤ Subscribe PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE); REGISTERED: UK EU1/10/612/001 20100311; UK EU1/10/612/002 20100311; UK EU1/10/612/003 20100311; UK EU1/10/612/004 20100311; UK EU1/10/612/005 20100311; UK EU1/10/612/006 20100311
C0044 France ➤ Subscribe PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 20000928
90055-0 Sweden ➤ Subscribe PRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414
90025-5 Sweden ➤ Subscribe PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-003 20110317
70017 Netherlands ➤ Subscribe PRODUCT NAME: TOPOTECAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZOUT, HYDRAAT OF SOLVAAT, IN HET BIJZONDER HET HYDROCHLORI DE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 - EU/1/96/027/002 19961112; FIRST REGISTRATION: CH IKS 53857 19961016
2010007 Lithuania ➤ Subscribe PRODUCT NAME: ELTROMBOPAGUM OLAMINUM; REGISTRATION NO/DATE: EU/1/10/612/001, 2010 03 11 EU/1/10/612/002, 2010 03 11 EU/1/10/612/003, 2010 03 11 EU/1/10/612/004, 2010 03 11 EU/1/10/612/005, 2010 03 11 EU/1/10/612/006 20100311
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Medtronic
QuintilesIMS
Johnson and Johnson
Cipla
Accenture
Fuji
US Army
US Department of Justice
Federal Trade Commission

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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