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Serving leading biopharmaceutical companies globally:

US Army
Chubb
AstraZeneca
Medtronic
Argus Health
Harvard Business School
Merck
Covington
Mallinckrodt
Boehringer Ingelheim

Generated: February 25, 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 seventy-seven 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 two hundred and forty-two patent family members on NOVARTIS drugs in seventy-six countries and three hundred and thirty-eight supplementary protection certificates in fifteen countries.

Summary for NOVARTIS
International Patents:3242
US Patents:177
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 TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-001 Aug 26, 2010 DISCN No No 5,559,111 ➤ Sign Up Y Y ➤ Sign Up
Novartis Pharms Corp CYCLOGYL cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084109-001 Approved Prior to Jan 1, 1982 AT RX No Yes ➤ Sign Up ➤ Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-003 Aug 26, 2010 DISCN No No 8,613,949 ➤ Sign Up Y ➤ Sign Up
Novartis SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677-001 Dec 14, 2012 RX Yes No 7,473,761 ➤ Sign Up Y Y ➤ Sign Up
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes 7,169,791 ➤ Sign Up Y Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes 7,795,293*PED ➤ Sign Up Y ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-001 Apr 30, 2009 AB RX Yes No 8,475,839*PED ➤ Sign Up Y ➤ Sign Up
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996 DISCN Yes No ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-001 May 29, 2013 RX Yes No 7,378,423 ➤ Sign Up Y Y ➤ Sign Up
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 ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 6,455,518*PED ➤ Sign Up
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-004 Jun 12, 1991 4,395,403 ➤ Sign Up
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 RE34990 ➤ Sign Up
Novartis FAMVIR famciclovir TABLET;ORAL 020363-002 Jun 29, 1994 5,916,893*PED ➤ Sign Up
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-007 Apr 11, 2006 6,162,802 ➤ Sign Up
Novartis Pharms Corp ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993 4,753,789*PED ➤ Sign Up
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-008 Jan 8, 1999 5,474,783 ➤ Sign Up
Novartis LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 4,680,291 ➤ Sign Up
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-002 Nov 25, 1998 4,395,403 ➤ Sign Up
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-006 Apr 21, 2000 4,948,807 ➤ Sign Up
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
➤ Sign Up ➤ Sign Up
➤ Sign Up ➤ Sign Up

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
8,343,984 Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide ➤ Sign Up
9,540,334 2,4-pyrimidinediamine compounds and their uses ➤ Sign Up
9,554,993 Pulmonary delivery particles comprising an active agent ➤ Sign Up
7,332,484 2,4-pyrimidinediamine compounds and their uses ➤ Sign Up
9,040,550 2,4-pyrimidinediamine compounds and their uses ➤ Sign Up
8,557,806 Methods of treating or preventing autoimmune diseases with 2,4-pyrimidinediamine compounds ➤ Sign Up
6,605,613 Macrolides ➤ Sign Up
9,439,862 Phospholipid-based powders for drug delivery ➤ Sign Up
6,596,750 Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators ➤ Sign Up
8,334,296 2,4-pyrimidinediamine compounds and their uses ➤ Sign Up
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
2011010,C1613288 Lithuania ➤ Sign Up PRODUCT NAME: FINGOLIMODUM; REGISTRATION NO/DATE: EU/1/11/677/001, 2011-03-17 EU/1/11/677/002, 2011-03-17 EU/1/11/677/003, 2011-03-17 EU/1/11/677/004 20110317
330 Luxembourg ➤ Sign Up CERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
0 Finland ➤ Sign Up
C/GB11/045 United Kingdom ➤ Sign Up PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
C/GB10/032 United Kingdom ➤ Sign Up PRODUCT NAME: PAZOPANIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; REGISTERED: UK EU 1/10/628/001 20100614; UK EU 1/10/628/002 20100614; UK EU 1/10/628/003 20100614; UK EU 1/10/628/004 20100614
710 Luxembourg ➤ Sign Up 91710, EXPIRES: 20250614
C017/2004 Ireland ➤ Sign Up SPC017/2004, 20060201, EXPIRES: 20171023
C0045 France ➤ Sign Up PRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EU/1/01/199/001 20011127
37/2008 Austria ➤ Sign Up PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON
00488 Netherlands ➤ Sign Up PRODUCT 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
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 hundreds of leading biopharmaceutical companies globally:

Dow
AstraZeneca
Federal Trade Commission
UBS
Teva
Cerilliant
Cantor Fitzgerald
Queensland Health
Harvard Business School

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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