Novartis Company Profile

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What is the competitive landscape for NOVARTIS, and when can generic versions of NOVARTIS drugs launch?

NOVARTIS has one hundred and eighty-seven approved drugs.

There are one hundred and thirteen US patents protecting NOVARTIS drugs.

There are two thousand eight hundred and seventy-one patent family members on NOVARTIS drugs in sixty-nine countries and five hundred and thirty supplementary protection certificates in nineteen countries.

Summary for Novartis

International Patents:	2871
US Patents:	113
Tradenames:	155
Ingredients:	139
NDAs:	187
Drug Master File Entries:	1
Patent Litigation for Novartis:	See patent lawsuits for Novartis
PTAB Cases with Novartis as patent owner:	See PTAB cases with Novartis as patent owner

Drugs and US Patents for Novartis

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TRILEPTAL	oxcarbazepine	SUSPENSION;ORAL	021285-001	May 25, 2001	AB	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-001	Dec 22, 2000		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	10,669,544	⤷ Sign Up		Y		⤷ Sign Up
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	8,835,443*PED	⤷ Sign Up			Y	⤷ Sign Up
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015	AB	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Novartis	TAFINLAR	dabrafenib mesylate	TABLET, FOR SUSPENSION;ORAL	217514-001	Mar 16, 2023		RX	Yes	Yes	11,504,333*PED	⤷ Sign Up			Y	⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-004	Apr 21, 2000	4,948,807	⤷ Sign Up
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,283,362	⤷ Sign Up
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006	7,795,238	⤷ Sign Up
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-001	Nov 25, 1998	5,538,739*PED	⤷ Sign Up
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998	5,922,682*PED	⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	5,399,578*PED	⤷ Sign Up
>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	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
➤ 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

International Patents for Novartis Drugs

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Country	Patent Number	Estimated Expiration
Japan	7194161	⤷ Sign Up
European Patent Office	4159205	⤷ Sign Up
Uruguay	33818	⤷ Sign Up
European Patent Office	3268337	⤷ Sign Up
Guatemala	200900147	⤷ Sign Up
South Korea	20200136493	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for Novartis Drugs

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	C01761528/01	Switzerland	⤷ Sign Up	PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016
2269604	62/2016	Austria	⤷ Sign Up	PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805
2782584	C202130068	Spain	⤷ Sign Up	PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406
1638574	C20170046 00256	Estonia	⤷ Sign Up	PRODUCT NAME: MIDOSTAURIIN;REG NO/DATE: EU/1/17/1218 20.09.2017
1638574	300917	Netherlands	⤷ Sign Up	PRODUCT NAME: MIDOSTAURINE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1507558	18/2012	Austria	⤷ Sign Up	PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - 060 20111122; FIRST REGISTRATION: LI 61678 01-61678 05 20110705
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Similar Applicant Names

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Here is a list of applicants with similar names.

Summary for Novartis

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Similar Applicant Names

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