NOVARTIS Company Profile

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

NOVARTIS has two hundred and fifteen approved drugs.

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

There are three thousand eight hundred and eighty-three patent family members on NOVARTIS drugs in seventy-three countries and five hundred and fifteen supplementary protection certificates in nineteen countries.

Summary for NOVARTIS

International Patents:	3883
US Patents:	153
Tradenames:	181
Ingredients:	156
NDAs:	215
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	SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625-003	Nov 23, 1992	BX	RX	Yes	No
Novartis	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-003	Nov 13, 2001	AB	RX	Yes	Yes
Novartis	SANSERT	methysergide maleate	TABLET;ORAL	012516-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015		RX	Yes	Yes	7,160,870*PED				Y

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	5,463,116
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	Jul 14, 1995	6,007,840
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-002	Apr 20, 2010	6,440,990*PED
Novartis	SANOREX	mazindol	TABLET;ORAL	017247-002	Approved Prior to Jan 1, 1982	3,763,178

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	180 mg		2016-04-28
	Nasal Spray	0.665 mg/ Spray		2009-06-29
	Capsules	400 mg		2014-01-24
	Tablets	10 mg/320 mg		2007-11-09
	Otic Suspension	0.3%/0.1%		2012-07-31
	Capsules	2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg		2004-06-09
	Tablets	10 mg/12.5 mg/160 mg		2009-10-22
	Oral Suspension	300 mg/5 mL		2006-12-26
	Extended-release Capsules	5mg, 10mg and 20 mg		2007-03-30
	Tablets	2.5 mg		2004-07-27
	Capsules	150 mg and 200 mg		2013-01-29
	Extended-release Capsule	40 mg		2010-12-20
	Delayed-release Tablets	180 mg		2009-06-04
	Tablets	50 mg and 75 mg		2014-01-07
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	Extended-release capsules	35 mg		2011-09-29
	Extended-release Tablets	100 mg		2005-12-30
	Tablets	60 mg and 120 mg		2004-12-22
	Oral Solution	4 mg/5 mL		2004-12-20
	Extended-release Capsules	20 mg, 30 mg and 40 mg		2006-08-21
	Tablets	10 mg		2014-06-18
	Tablets	0.25 mg, 0.5 mg, and 0.75 mg		2013-09-30
	Injection	0.8 mg (base) /mL		2008-06-11
	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg		2004-04-21
	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg		2005-12-02
	Tablets	2.5 mg		2006-03-02
	Ophthalmic Solution	0.003%		2015-12-30
	Transdermal System Extended-release	13.3 mg/24 hr		2013-01-22
	Tablets	5 mg/160 mg		2007-10-22
	Tablets	180 mg		2015-10-23
	Ophthalmic	0.50%		2005-12-22
	Tablets	100 mg and 400 mg		2007-03-12
	Tablets	10 mg/160 mg		2007-10-01
	Ophthalmic Suspension	0.3%		2015-12-21
	Capsules	20 mg and 40 mg		2008-06-04
	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
	Tablets	150 mg, 300 mg and 600 mg		2006-05-05
	Extended-release Capsules	15 mg		2007-05-14
	Capsules	5 mg/40 mg and 10 mg/40 mg		2006-11-17
	Tablets	125 mg, 250 mg and 500 mg		2004-12-28
	Delayed-release Tablets	360 mg		2009-02-02
	Extended-release Capsule	30 mg		2010-12-15
	Tablets	5 mg and 10 mg		2004-05-27
	Ophthalmic Emulsion	0.05%		2014-05-01
	Extended-release capsules	25 mg		2011-09-30
	Extended-release Tablets	80 mg		2007-03-15
	Tablets	12.5 mg and 25 mg		2014-02-04
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	Extended-release Capsules	10 mg		2007-05-21
	Tablets	125 mg, 250 mg, and 500 mg		2011-10-28
	Tablets	250 mg		2011-03-14
	Injection	0.05 mg/mL, 100 mL vial		2008-08-29
	Tablets	40 mg, 80 mg,160 mg		2004-12-28
	Tablets	2.5 mg, 5 mg, and 7.5 mg		2014-12-10
	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg		2016-12-30
	Injection	4 mg/100 mg, 100 mL vial		2012-01-31
	Oral Solution	2 mg/mL		2004-11-05
	Tablets	320 mg/12.5 mg and 320 mg/25 mg		2007-02-07
	Tablets	90 mg and 360 mg		2015-10-19
	Ophthalmic Solution	0.00%		2009-02-19
	Capsules	0.5 mg		2014-09-22
	Tablets	5 mg/320 mg		2007-11-26

International Patents for NOVARTIS Drugs

Country	Patent Number	Estimated Expiration
New Zealand	590754
Croatia	P20180126
Japan	5560496
China	103998041

Supplementary Protection Certificates for NOVARTIS Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
2929031	LUC00209	Luxembourg		PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
2379069	2020C/526	Belgium		PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115

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