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Last Updated: March 28, 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 ISMELIN guanethidine monosulfate TABLET;ORAL 012329-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Novartis HYDERGINE ergoloid mesylates SOLUTION;ORAL 018418-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial
Novartis LIORESAL baclofen TABLET;ORAL 017851-003 Jan 20, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a 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 DIOVAN valsartan TABLET;ORAL 021283-002 Jul 18, 2001 5,972,990*PED ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-005 Apr 28, 2006 6,294,197*PED ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 7,160,870*PED ⤷  Try a Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-001 Feb 27, 1996 4,849,226 ⤷  Try a 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 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
➤ 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

Supplementary Protection Certificates for Novartis Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3351246 2019C/550 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
1602370 09C0020 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
1294378 122010000037 Germany ⤷  Try a Trial PRODUCT NAME: ELTROMBOPAG SOWIE PHARMAZEUTISCH ANNEHMBARE SALZE, HYDRATE UND SOLVATE DAVON; NAT. REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311; FIRST REGISTRATION: EU EU/1/10/612/001-/006 20100311
2379069 2020C/526 Belgium ⤷  Try a Trial PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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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.