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Last Updated: December 22, 2024

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 Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-002 May 6, 2020 RX Yes Yes 8,420,645 ⤷  Subscribe Y Y ⤷  Subscribe
Novartis Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-002 May 6, 2020 RX Yes Yes 7,767,675 ⤷  Subscribe Y Y ⤷  Subscribe
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 AB RX Yes No 9,006,224 ⤷  Subscribe ⤷  Subscribe
Novartis Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-002 May 6, 2020 RX Yes Yes 8,461,330 ⤷  Subscribe Y Y ⤷  Subscribe
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 RX Yes No 8,828,430*PED ⤷  Subscribe Y ⤷  Subscribe
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes 8,703,787 ⤷  Subscribe ⤷  Subscribe
Novartis FORADIL CERTIHALER formoterol fumarate POWDER;INHALATION 021592-001 Dec 15, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe
>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 TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 6,444,652 ⤷  Subscribe
Novartis ESTRADERM estradiol SYSTEM;TRANSDERMAL 019081-003 Sep 10, 1986 3,948,262 ⤷  Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996 4,954,344 ⤷  Subscribe
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 6,004,973*PED ⤷  Subscribe
Novartis SEEBRI glycopyrrolate POWDER;INHALATION 207923-001 Oct 29, 2015 6,582,678 ⤷  Subscribe
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 8,617,598*PED ⤷  Subscribe
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 7,795,238 ⤷  Subscribe
>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 180 mg ➤ Subscribe 2016-04-28
➤ Subscribe Capsules 20 mg and 40 mg ➤ Subscribe 2008-06-04
➤ Subscribe Tablets 5 mg/320 mg ➤ Subscribe 2007-11-26
➤ Subscribe Injection 0.8 mg (base) /mL ➤ Subscribe 2008-06-11
➤ Subscribe Tablets 10 mg/320 mg ➤ Subscribe 2007-11-09
➤ Subscribe Ophthalmic Solution 0.003% ➤ Subscribe 2015-12-30
➤ Subscribe Tablets 10 mg/12.5 mg/160 mg ➤ Subscribe 2009-10-22
➤ Subscribe Tablets 150 mg, 300 mg and 600 mg ➤ Subscribe 2006-05-05
➤ Subscribe Tablets 50 mg and 75 mg ➤ Subscribe 2014-01-07
➤ Subscribe Delayed-release Tablets 360 mg ➤ Subscribe 2009-02-02
➤ Subscribe Tablets 60 mg and 120 mg ➤ Subscribe 2004-12-22
➤ Subscribe Tablets 40 mg, 80 mg,160 mg ➤ Subscribe 2004-12-28
➤ Subscribe Extended-release Tablets 100 mg ➤ Subscribe 2005-12-30
➤ Subscribe Tablets 0.25 mg, 0.5 mg, and 0.75 mg ➤ Subscribe 2013-09-30
➤ Subscribe Oral Solution 2 mg/mL ➤ Subscribe 2004-11-05
➤ Subscribe Tablets 10 mg ➤ Subscribe 2014-06-18
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2006-03-02
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 2014-09-22
➤ Subscribe Tablets 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg ➤ Subscribe 2005-12-02
➤ Subscribe Tablets 180 mg ➤ Subscribe 2015-10-23
➤ Subscribe Capsules 400 mg ➤ Subscribe 2014-01-24
➤ Subscribe Tablets 5 mg/160 mg ➤ Subscribe 2007-10-22
➤ Subscribe Capsules 150 mg and 200 mg ➤ Subscribe 2013-01-29
➤ Subscribe Tablets 10 mg/160 mg ➤ Subscribe 2007-10-01
➤ Subscribe Injection 4 mg/100 mg, 100 mL vial ➤ Subscribe 2012-01-31
➤ 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 Nasal Spray 0.665 mg/ Spray ➤ Subscribe 2009-06-29
➤ Subscribe Tablets 125 mg, 250 mg and 500 mg ➤ Subscribe 2004-12-28
➤ Subscribe Oral Suspension 300 mg/5 mL ➤ Subscribe 2006-12-26
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe 2014-02-04
➤ Subscribe Delayed-release Tablets 180 mg ➤ Subscribe 2009-06-04
➤ Subscribe Tablets 250 mg ➤ Subscribe 2011-03-14
➤ Subscribe Capsules 1.5 mg, 3 mg, 4.5 mg and 6 mg ➤ Subscribe 2004-04-21
➤ Subscribe Tablets 125 mg, 250 mg, and 500 mg ➤ Subscribe 2011-10-28
➤ Subscribe Tablets for Oral Suspension 2 mg, 3 mg and 5 mg ➤ Subscribe 2016-12-30
➤ Subscribe Transdermal System Extended-release 13.3 mg/24 hr ➤ Subscribe 2013-01-22
➤ Subscribe Tablets 2.5 mg, 5 mg, and 7.5 mg ➤ Subscribe 2014-12-10
➤ Subscribe Tablets 90 mg and 360 mg ➤ Subscribe 2015-10-19
➤ Subscribe Tablets 100 mg and 400 mg ➤ Subscribe 2007-03-12
➤ Subscribe Tablets 320 mg/12.5 mg and 320 mg/25 mg ➤ Subscribe 2007-02-07

Supplementary Protection Certificates for NOVARTIS Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331537 2020C/547 Belgium ⤷  Subscribe PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728
3143995 2019C/528 Belgium ⤷  Subscribe DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
1948158 PA2016017 Lithuania ⤷  Subscribe PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1948158 132016000051118 Italy ⤷  Subscribe PRODUCT NAME: SACUBITRIL/VALSARTAN, COME SACUBITRIL VALSARTAN COMPLESSO DI SALE SODICO (TRISODIO (3-((1S,3R)-1-BIFENIL-4-ILMETIL-3-ETOSSICARBONIL-1-BUTILCARBAMMOIL)PROPIONATO-(S)-3'-METIL-2'-(PENTANOIL(2"-(TETRAZOL-5-ILATO)BIFENIL-4'-ILMETIL)AMMINO)BUTIRRATO) EMIPENTAIDRATO)(ENTRESTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1058, 20151123
0678503 C300386 Netherlands ⤷  Subscribe PRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028
3143995 C03143995/01 Switzerland ⤷  Subscribe PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 14.11.2016
2331547 C20170039 00245 Estonia ⤷  Subscribe PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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