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Last Updated: August 7, 2020

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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 SLOW-K potassium chloride TABLET, EXTENDED RELEASE;ORAL 017476-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Novartis MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050065-002 Approved Prior to Jan 1, 1982 AT RX Yes Yes   Start Trial   Start Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-001 May 29, 2013 RX Yes No   Start Trial   Start Trial
Novartis VOLTAREN diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020037-001 Mar 28, 1991 AT RX Yes Yes   Start Trial   Start Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes 8,580,304   Start Trial Y   Start Trial
Novartis OCUPRESS carteolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019972-001 May 23, 1990 DISCN Yes No   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 RX Yes No 8,828,430*PED   Start Trial Y   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 TRILEPTAL oxcarbazepine TABLET;ORAL 021014-003 Jan 14, 2000 7,037,525*PED   Start Trial
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992 4,753,789*PED   Start Trial
Novartis LOPRESSIDONE chlorthalidone; metoprolol tartrate CAPSULE;ORAL 019451-001 Dec 31, 1987 3,998,790   Start Trial
Novartis TRASICOR oxprenolol hydrochloride CAPSULE;ORAL 018166-004 Dec 28, 1983 3,483,221   Start Trial
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003 5,521,184*PED   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 6,239,124*PED   Start Trial
Novartis SANOREX mazindol TABLET;ORAL 017247-002 Approved Prior to Jan 1, 1982 3,763,178   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 Injection 0.05 mg/mL, 100 mL vial ➤ Subscribe 2008-08-29
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe 2014-02-04
➤ Subscribe Tablets 125 mg, 250 mg, and 500 mg ➤ Subscribe 2011-10-28
➤ Subscribe Tablets 40 mg, 80 mg,160 mg ➤ Subscribe 2004-12-28
➤ Subscribe Injection 4 mg/100 mg, 100 mL vial ➤ Subscribe 2012-01-31
➤ Subscribe Tablets 250 mg ➤ Subscribe 2011-03-14
➤ Subscribe Tablets 2.5 mg, 5 mg, and 7.5 mg ➤ Subscribe 2014-12-10
➤ Subscribe Oral Solution 2 mg/mL ➤ Subscribe 2004-11-05
➤ Subscribe Tablets for Oral Suspension 2 mg, 3 mg and 5 mg ➤ Subscribe 2016-12-30
➤ Subscribe Ophthalmic Solution 10.5% ➤ Subscribe 2012-02-29
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 2014-09-22
➤ Subscribe Tablets 320 mg/12.5 mg and 320 mg/25 mg ➤ Subscribe 2007-02-07
➤ Subscribe Tablets 90 mg and 360 mg ➤ Subscribe 2015-10-19
➤ Subscribe Ophthalmic Solution 0.00% ➤ Subscribe 2009-02-19
➤ Subscribe Capsules 400 mg ➤ Subscribe 2014-01-24
➤ Subscribe Tablets 5 mg/320 mg ➤ Subscribe 2007-11-26
➤ Subscribe Tablets 180 mg ➤ Subscribe 2016-04-28
➤ Subscribe Nasal Spray 0.665 mg/ Spray ➤ Subscribe 2009-06-29
➤ 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 Tablets 10 mg/320 mg ➤ Subscribe 2007-11-09
➤ Subscribe Otic Suspension 0.3%/0.1% ➤ Subscribe 2012-07-31
➤ Subscribe Extended-release Capsules 5mg, 10mg and 20 mg ➤ Subscribe 2007-03-30
➤ Subscribe Capsules 150 mg and 200 mg ➤ Subscribe 2013-01-29
➤ Subscribe Tablets 10 mg/12.5 mg/160 mg ➤ Subscribe 2009-10-22
➤ Subscribe Oral Suspension 300 mg/5 mL ➤ Subscribe 2006-12-26
➤ Subscribe Extended-release Capsule 40 mg ➤ Subscribe 2010-12-20
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2004-07-27
➤ Subscribe Delayed-release Tablets 180 mg ➤ Subscribe 2009-06-04
➤ Subscribe Extended-release capsules 35 mg ➤ Subscribe 2011-09-29
➤ Subscribe Oral Solution 4 mg/5 mL ➤ Subscribe 2004-12-20
➤ Subscribe Tablets 50 mg and 75 mg ➤ Subscribe 2014-01-07
➤ Subscribe Extended-release Tablets 100 mg ➤ Subscribe 2005-12-30
➤ Subscribe Extended-release Capsules 20 mg, 30 mg and 40 mg ➤ Subscribe 2006-08-21
➤ Subscribe Injection 0.8 mg (base) /mL ➤ Subscribe 2008-06-11
➤ Subscribe Tablets 60 mg and 120 mg ➤ Subscribe 2004-12-22
➤ Subscribe Tablets 10 mg ➤ Subscribe 2014-06-18
➤ Subscribe Capsules 1.5 mg, 3 mg, 4.5 mg and 6 mg ➤ Subscribe 2004-04-21
➤ Subscribe Ophthalmic Solution 0.003% ➤ Subscribe 2015-12-30
➤ Subscribe Tablets 0.25 mg, 0.5 mg, and 0.75 mg ➤ Subscribe 2013-09-30
➤ Subscribe Tablets 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg ➤ Subscribe 2005-12-02
➤ Subscribe Transdermal System Extended-release 13.3 mg/24 hr ➤ Subscribe 2013-01-22
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2006-03-02
➤ Subscribe Ophthalmic Solution 0.7% ➤ Subscribe 2015-09-10
➤ Subscribe Tablets 100 mg and 400 mg ➤ Subscribe 2007-03-12
➤ Subscribe Tablets 5 mg/160 mg ➤ Subscribe 2007-10-22
➤ Subscribe Tablets 180 mg ➤ Subscribe 2015-10-23
➤ Subscribe Ophthalmic 0.50% ➤ Subscribe 2005-12-22
➤ Subscribe Capsules 20 mg and 40 mg ➤ Subscribe 2008-06-04
➤ Subscribe Tablets 10 mg/160 mg ➤ Subscribe 2007-10-01
➤ Subscribe Ophthalmic Suspension 0.3% ➤ Subscribe 2015-12-21
➤ Subscribe Extended-release Capsules 15 mg ➤ Subscribe 2007-05-14
➤ Subscribe Capsules 5 mg/40 mg and 10 mg/40 mg ➤ Subscribe 2006-11-17
➤ 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 Tablets 150 mg, 300 mg and 600 mg ➤ Subscribe 2006-05-05
➤ Subscribe Extended-release Capsule 30 mg ➤ Subscribe 2010-12-15
➤ Subscribe Ophthalmic Emulsion 0.05% ➤ Subscribe 2014-05-01
➤ Subscribe Tablets 125 mg, 250 mg and 500 mg ➤ Subscribe 2004-12-28
➤ Subscribe Delayed-release Tablets 360 mg ➤ Subscribe 2009-02-02
➤ Subscribe Extended-release capsules 25 mg ➤ Subscribe 2011-09-30
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2004-05-27
➤ Subscribe Extended-release Tablets 80 mg ➤ Subscribe 2007-03-15
➤ Subscribe Extended-release Capsules 10 mg ➤ Subscribe 2007-05-21

Supplementary Protection Certificates for NOVARTIS Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3342411 122020000008 Germany   Start Trial PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20110824
1948158 1690020-1 Sweden   Start Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
2331547 PA2017039,C2331547 Lithuania   Start Trial PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
1761528 C01761528/01 Switzerland   Start Trial PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016
0443983 SPC/GB97/009 United Kingdom   Start Trial PRODUCT NAME: VALSARTAN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 36983.00.00 19960513; DE 36983.01.00 19960513; UK 00001/0218 19961016; UK 00001/0219 19961016; UK 00001/0225 19961016
1272477 15C0064 France   Start Trial PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/999 20150508
3143995 300992 Netherlands   Start Trial PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/538/001,003,004,006-010 (C(2016)3286) 20160530
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
McKesson
Express Scripts
Baxter
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 verification 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.