Novartis Company Profile

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

NOVARTIS has one hundred and eighty-five approved drugs.

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

There are two thousand seven hundred and forty-seven patent family members on NOVARTIS drugs in sixty-nine countries and five hundred and twenty supplementary protection certificates in nineteen countries.

Summary for Novartis

International Patents:	2747
US Patents:	103
Tradenames:	154
Ingredients:	139
NDAs:	185
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-003	Aug 24, 2021		RX	Yes	No
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes	9,309,229		Y	Y
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-003	Mar 30, 2015	AB	RX	Yes	Yes	9,283,209		Y	Y
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015		RX	Yes	No	11,058,667
Novartis	APRESAZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	084735-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes	9,416,136

Expired US Patents for Novartis

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000	6,641,841
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010	5,559,111
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	7,332,481*PED
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-002	Sep 10, 1986	4,379,454
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-003	Jan 20, 1982	3,471,548
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	5,342,625

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	5 mg/160 mg		2007-10-22
	Capsules	150 mg and 200 mg		2013-01-29
	Tablets	10 mg/160 mg		2007-10-01
	Injection	4 mg/100 mg, 100 mL vial		2012-01-31
	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		2009-09-14
	Nasal Spray	0.665 mg/ Spray		2009-06-29
	Tablets	125 mg, 250 mg and 500 mg		2004-12-28
	Oral Suspension	300 mg/5 mL		2006-12-26
	Tablets	12.5 mg and 25 mg		2014-02-04
	Delayed-release Tablets	180 mg		2009-06-04
	Tablets	250 mg		2011-03-14
	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg		2004-04-21
	Tablets	125 mg, 250 mg, and 500 mg		2011-10-28
	Transdermal System Extended-release	13.3 mg/24 hr		2013-01-22
	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg		2016-12-30
	Tablets	2.5 mg, 5 mg, and 7.5 mg		2014-12-10
	Tablets	100 mg and 400 mg		2007-03-12
	Tablets	90 mg and 360 mg		2015-10-19
	Tablets	320 mg/12.5 mg and 320 mg/25 mg		2007-02-07
	Capsules	20 mg and 40 mg		2008-06-04
	Tablets	180 mg		2016-04-28
	Tablets	5 mg/320 mg		2007-11-26
	Injection	0.8 mg (base) /mL		2008-06-11
	Tablets	10 mg/320 mg		2007-11-09
	Ophthalmic Solution	0.003%		2015-12-30
	Tablets	10 mg/12.5 mg/160 mg		2009-10-22
	Tablets	150 mg, 300 mg and 600 mg		2006-05-05
	Tablets	50 mg and 75 mg		2014-01-07
	Delayed-release Tablets	360 mg		2009-02-02
	Tablets	60 mg and 120 mg		2004-12-22
	Tablets	40 mg, 80 mg,160 mg		2004-12-28
	Extended-release Tablets	100 mg		2005-12-30
	Tablets	0.25 mg, 0.5 mg, and 0.75 mg		2013-09-30
	Oral Solution	2 mg/mL		2004-11-05
	Tablets	10 mg		2014-06-18
	Capsules	0.5 mg		2014-09-22
	Tablets	2.5 mg		2006-03-02
	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg		2005-12-02
	Capsules	400 mg		2014-01-24
	Tablets	180 mg		2015-10-23

International Patents for Novartis Drugs

Country	Patent Number	Estimated Expiration
San Marino	P200800069
China	1615134
European Patent Office	2021507
European Patent Office	2152237
Japan	7407508
Hong Kong	1197723

Supplementary Protection Certificates for Novartis Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	LUC00195	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
2379069	LUC00160	Luxembourg		PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115
1273292	C01273292/01	Switzerland		PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
2929031	C20210012 00398	Estonia		PRODUCT NAME: INKLISIRAAN;REG NO/DATE: EU/1/20/1494 10.12.2020
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Nova Labs Ltd
• Novadaq Tech
• Novartis
• Novartis Pharm
• Novartis Pharms
• Novartis Pharms Corp