Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Moodys
Baxter
Boehringer Ingelheim
Express Scripts

Last Updated: November 13, 2019

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NOVARTIS Company Profile

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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 APRESOLINE hydralazine hydrochloride INJECTABLE;INJECTION 008303-003 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-003 Mar 22, 2018 RX Yes No   Start Trial   Start Trial
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-001 Oct 21, 1988 AP RX Yes Yes   Start Trial   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015 RX Yes No   Start Trial   Start Trial
Novartis SULF-10 sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 080025-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Novartis Pharms Corp ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes 8,039,479   Start Trial Y Y   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 RX Yes Yes   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 021802-001 May 26, 2005 6,528,530   Start Trial
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 5,578,628*PED   Start Trial
Novartis VIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020323-002 Oct 28, 1994 4,994,267   Start Trial
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 6,403,609   Start Trial
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-002 Jun 20, 2007 6,294,197*PED   Start Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995 5,985,321   Start Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-002 Jul 14, 1995 6,024,978   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for NOVARTIS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Ophthalmic Solution 0.10% ➤ Subscribe 2006-07-17
➤ Subscribe Injection 4 mg/100 mg, 100 mL vial ➤ Subscribe 2012-01-31
➤ Subscribe Extended-release Capsules 10 mg ➤ Subscribe 2007-05-21
➤ Subscribe Tablets 10 mg/12.5 mg/160 mg ➤ Subscribe 2009-10-22
➤ Subscribe Ophthalmic Solution 0.00% ➤ Subscribe 2009-02-19
➤ Subscribe Oral Suspension 300 mg/5 mL ➤ Subscribe 2006-12-26
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2004-07-27
➤ Subscribe Tablets 40 mg, 80 mg,160 mg ➤ Subscribe 2004-12-28
➤ Subscribe Nasal Spray 0.665 mg/ Spray ➤ Subscribe 2009-06-29
➤ Subscribe Delayed-release Tablets 180 mg ➤ Subscribe 2009-06-04
➤ Subscribe Tablets 60 mg and 120 mg ➤ Subscribe 2004-12-22
➤ Subscribe Oral Solution 2 mg/mL ➤ Subscribe 2004-11-05
➤ Subscribe Otic Suspension 0.3%/0.1% ➤ Subscribe 2012-07-31
➤ Subscribe Extended-release Tablets 100 mg ➤ Subscribe 2005-12-30
➤ Subscribe Tablets for Oral Suspension 2 mg, 3 mg and 5 mg ➤ Subscribe 2016-12-30
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 2014-09-22
➤ Subscribe Tablets 180 mg ➤ Subscribe 2015-10-23
➤ Subscribe Tablets 10 mg ➤ Subscribe 2014-06-18
➤ Subscribe Ophthalmic Emulsion 0.05% ➤ Subscribe 2014-05-01
➤ Subscribe Capsules 400 mg ➤ Subscribe 2014-01-24
➤ Subscribe Tablets 50 mg and 75 mg ➤ Subscribe 2014-01-07
➤ Subscribe Tablets 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg ➤ Subscribe 2005-12-02
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Capsules 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg ➤ Subscribe 2004-06-09
➤ Subscribe Extended-release Capsules 5mg, 10mg and 20 mg ➤ Subscribe 2007-03-30
➤ Subscribe Tablets 250 mg ➤ Subscribe 2011-03-14
➤ Subscribe Tablets 5 mg/160 mg ➤ Subscribe 2007-10-22
➤ Subscribe Ophthalmic Solution 0.003% ➤ Subscribe 2015-12-30
➤ Subscribe Capsules 150 mg and 200 mg ➤ Subscribe 2013-01-29
➤ Subscribe Extended-release Capsule 40 mg ➤ Subscribe 2010-12-20
➤ Subscribe Tablets 10 mg/160 mg ➤ Subscribe 2007-10-01
➤ Subscribe Ophthalmic Solution 0.20% ➤ Subscribe 2008-09-08
➤ Subscribe Injection 0.8 mg (base) /mL ➤ Subscribe 2008-06-11
➤ Subscribe Extended-release capsules 35 mg ➤ Subscribe 2011-09-29
➤ 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 2009-09-14
➤ Subscribe Ophthalmic Solution 0.7% ➤ Subscribe 2015-09-10
➤ Subscribe Tablets 150 mg, 300 mg and 600 mg ➤ Subscribe 2006-05-05
➤ Subscribe Extended-release Capsules 20 mg, 30 mg and 40 mg ➤ Subscribe 2006-08-21
➤ Subscribe Tablets 125 mg, 250 mg and 500 mg ➤ Subscribe 2004-12-28
➤ Subscribe Ophthalmic 0.50% ➤ Subscribe 2005-12-22
➤ Subscribe Delayed-release Tablets 360 mg ➤ Subscribe 2009-02-02
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2004-05-27
➤ Subscribe Capsules 1.5 mg, 3 mg, 4.5 mg and 6 mg ➤ Subscribe 2004-04-21
➤ Subscribe Ophthalmic Suspension 0.3% ➤ Subscribe 2015-12-21
➤ Subscribe Extended-release Tablets 80 mg ➤ Subscribe 2007-03-15
➤ Subscribe Tablets 0.25 mg, 0.5 mg, and 0.75 mg ➤ Subscribe 2013-09-30
➤ Subscribe Transdermal System Extended-release 13.3 mg/24 hr ➤ Subscribe 2013-01-22
➤ Subscribe Tablets 90 mg and 360 mg ➤ Subscribe 2015-10-19
➤ Subscribe Tablets 125 mg, 250 mg, and 500 mg ➤ Subscribe 2011-10-28
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2006-03-02
➤ Subscribe Tablets 100 mg and 400 mg ➤ Subscribe 2007-03-12
➤ Subscribe Tablets 180 mg ➤ Subscribe 2016-04-28
➤ Subscribe Tablets 2.5 mg, 5 mg, and 7.5 mg ➤ Subscribe 2014-12-10
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Capsules 20 mg and 40 mg ➤ Subscribe 2008-06-04
➤ Subscribe Extended-release Capsules 15 mg ➤ Subscribe 2007-05-14
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe 2014-02-04
➤ Subscribe Tablets 320 mg/12.5 mg and 320 mg/25 mg ➤ Subscribe 2007-02-07
➤ Subscribe Oral Solution 4 mg/5 mL ➤ Subscribe 2004-12-20
➤ Subscribe Capsules 5 mg/40 mg and 10 mg/40 mg ➤ Subscribe 2006-11-17
➤ Subscribe Extended-release Capsule 30 mg ➤ Subscribe 2010-12-15
➤ Subscribe Tablets 5 mg/320 mg ➤ Subscribe 2007-11-26
➤ Subscribe Ophthalmic Solution 10.5% ➤ Subscribe 2012-02-29
➤ Subscribe Injection 0.05 mg/mL, 100 mL vial ➤ Subscribe 2008-08-29
➤ Subscribe Extended-release capsules 25 mg ➤ Subscribe 2011-09-30
➤ Subscribe Tablets 10 mg/320 mg ➤ Subscribe 2007-11-09

Supplementary Protection Certificates for NOVARTIS Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 CA 2012 00018 Denmark   Start Trial
1104436 C01104436/01 Switzerland   Start Trial FORMER OWNER: CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, FR
0770388 PA2009004 Lithuania   Start Trial PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0321122 2/1997 Austria   Start Trial PRODUCT NAME: TOPOTECAN; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 EU/1/96/027/002 19961112; FIRST REGISTRATION: LI 53857 01 19961016
1467728 1690021-9 Sweden   Start Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123
2269603 PA2015041 Lithuania   Start Trial PRODUCT NAME: EVEROLIMUSUM; REGISTRATION NO/DATE: EU/1/09/538/001, EU/1/09/538/003, EU/1/09/538/004, EU/1/09/538/006-010 20120723
0294114 07C0058 France   Start Trial PRODUCT NAME: NELARABINE, OU L?UN DE SES DERIVES PHYSIOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/403/001 DU 20070822; REGISTRATION NO/DATE AT EEC: EU/1/07/403/001 DU 20070822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
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Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Medtronic
Harvard Business School
Express Scripts
Merck

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