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Harvard Business School
Colorcon
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim
McKinsey

Last Updated: December 15, 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 PIQRAY alpelisib TABLET;ORAL 212526-003 May 24, 2019 RX Yes Yes 8,476,268   Start Trial Y Y   Start Trial
Novartis HYDERGINE ergoloid mesylates TABLET;ORAL 017993-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial
Novartis FAMVIR famciclovir TABLET;ORAL 020363-003 Dec 11, 1995 DISCN Yes No   Start Trial   Start Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes   Start Trial   Start Trial
Novartis LOPRESSOR metoprolol fumarate TABLET, EXTENDED RELEASE;ORAL 019786-004 Dec 27, 1989 DISCN No No   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 ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-001 Dec 31, 1992 5,344,658*PED   Start Trial
Novartis AREDIA pamidronate disodium INJECTABLE;INJECTION 020036-003 May 6, 1993 3,962,432   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 6,063,802*PED   Start Trial
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-001 Nov 13, 2001 6,355,656   Start Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003 4,939,130*PED   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 Tablets 12.5 mg and 25 mg ➤ Subscribe 2014-02-04
➤ Subscribe Injection 4 mg/100 mg, 100 mL vial ➤ Subscribe 2012-01-31
➤ Subscribe Tablets 125 mg, 250 mg, and 500 mg ➤ Subscribe 2011-10-28
➤ Subscribe Oral Solution 2 mg/mL ➤ Subscribe 2004-11-05
➤ Subscribe Tablets 250 mg ➤ Subscribe 2011-03-14
➤ Subscribe Ophthalmic Solution 10.5% ➤ Subscribe 2012-02-29
➤ Subscribe Tablets 2.5 mg, 5 mg, and 7.5 mg ➤ Subscribe 2014-12-10
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 2014-09-22
➤ Subscribe Tablets for Oral Suspension 2 mg, 3 mg and 5 mg ➤ Subscribe 2016-12-30
➤ Subscribe Ophthalmic Solution 0.10% ➤ Subscribe 2006-07-17
➤ Subscribe Tablets 320 mg/12.5 mg and 320 mg/25 mg ➤ Subscribe 2007-02-07
➤ Subscribe Capsules 400 mg ➤ Subscribe 2014-01-24
➤ Subscribe Tablets 90 mg and 360 mg ➤ Subscribe 2015-10-19
➤ Subscribe Ophthalmic Solution 0.00% ➤ Subscribe 2009-02-19
➤ Subscribe Tablets 5 mg/320 mg ➤ Subscribe 2007-11-26
➤ 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 180 mg ➤ Subscribe 2016-04-28
➤ Subscribe Nasal Spray 0.665 mg/ Spray ➤ Subscribe 2009-06-29
➤ Subscribe Tablets 10 mg/320 mg ➤ Subscribe 2007-11-09
➤ Subscribe Capsules 150 mg and 200 mg ➤ Subscribe 2013-01-29
➤ Subscribe Extended-release Capsule 40 mg ➤ Subscribe 2010-12-20
➤ Subscribe Otic Suspension 0.3%/0.1% ➤ Subscribe 2012-07-31
➤ Subscribe Tablets 10 mg/12.5 mg/160 mg ➤ Subscribe 2009-10-22
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Extended-release capsules 35 mg ➤ Subscribe 2011-09-29
➤ Subscribe Oral Suspension 300 mg/5 mL ➤ Subscribe 2006-12-26
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2004-07-27
➤ Subscribe Oral Solution 4 mg/5 mL ➤ Subscribe 2004-12-20
➤ Subscribe Extended-release Capsules 20 mg, 30 mg and 40 mg ➤ Subscribe 2006-08-21
➤ Subscribe Delayed-release Tablets 180 mg ➤ Subscribe 2009-06-04
➤ Subscribe Tablets 50 mg and 75 mg ➤ Subscribe 2014-01-07
➤ Subscribe Injection 0.8 mg (base) /mL ➤ Subscribe 2008-06-11
➤ Subscribe Extended-release Tablets 100 mg ➤ Subscribe 2005-12-30
➤ Subscribe Capsules 1.5 mg, 3 mg, 4.5 mg and 6 mg ➤ Subscribe 2004-04-21
➤ Subscribe Tablets 60 mg and 120 mg ➤ Subscribe 2004-12-22
➤ Subscribe Ophthalmic Solution 0.003% ➤ Subscribe 2015-12-30
➤ Subscribe Tablets 10 mg ➤ Subscribe 2014-06-18
➤ Subscribe Transdermal System Extended-release 13.3 mg/24 hr ➤ Subscribe 2013-01-22
➤ Subscribe Tablets 0.25 mg, 0.5 mg, and 0.75 mg ➤ Subscribe 2013-09-30
➤ Subscribe Ophthalmic Solution 0.20% ➤ Subscribe 2008-09-08
➤ Subscribe Tablets 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg ➤ Subscribe 2005-12-02
➤ Subscribe Tablets 100 mg and 400 mg ➤ Subscribe 2007-03-12
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2006-03-02
➤ Subscribe Ophthalmic Solution 0.7% ➤ Subscribe 2015-09-10
➤ Subscribe Tablets 5 mg/160 mg ➤ Subscribe 2007-10-22
➤ Subscribe Capsules 20 mg and 40 mg ➤ Subscribe 2008-06-04
➤ Subscribe Extended-release Capsules 15 mg ➤ Subscribe 2007-05-14
➤ Subscribe Tablets 180 mg ➤ Subscribe 2015-10-23
➤ Subscribe Ophthalmic 0.50% ➤ Subscribe 2005-12-22
➤ Subscribe Tablets 10 mg/160 mg ➤ Subscribe 2007-10-01
➤ 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 Ophthalmic Suspension 0.3% ➤ Subscribe 2015-12-21
➤ 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 Emulsion 0.05% ➤ Subscribe 2014-05-01
➤ Subscribe Extended-release capsules 25 mg ➤ Subscribe 2011-09-30
➤ Subscribe Tablets 150 mg, 300 mg and 600 mg ➤ Subscribe 2006-05-05
➤ Subscribe Tablets 125 mg, 250 mg and 500 mg ➤ Subscribe 2004-12-28
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Extended-release Capsules 10 mg ➤ Subscribe 2007-05-21
➤ Subscribe Delayed-release Tablets 360 mg ➤ Subscribe 2009-02-02
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2004-05-27
➤ Subscribe Injection 0.05 mg/mL, 100 mL vial ➤ Subscribe 2008-08-29
➤ Subscribe Tablets 40 mg, 80 mg,160 mg ➤ Subscribe 2004-12-28
➤ Subscribe Extended-release Tablets 80 mg ➤ Subscribe 2007-03-15

Supplementary Protection Certificates for NOVARTIS Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280520 300722 Netherlands   Start Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
0443983 2007C/043 Belgium   Start Trial PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0443983 97C0039 Belgium   Start Trial PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
2091918 C 2015 037 Romania   Start Trial PRODUCT NAME: CERITINIBSAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA5-CLOR-N2-{(5-METIL-4-(PIPERIDIN-4-IL)-2-[(PROPAN-2-IL)OXI]FENIL-N4-[2-(PROPAN-2-SULFONIL)FENIL}PIRIMIDIN-2,4-DIAMINA; NATIONAL AUTHORISATION NUMBER: EU/1/15/999; DATE OF NATIONAL AUTHORISATION: 20150506; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/999; DATE OF FIRST AUTHORISATION IN EEA: 20150506
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Baxter
Dow
McKinsey
Johnson and Johnson

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.