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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 two hundred and sixteen approved drugs.

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

There are three thousand three hundred and seventeen patent family members on NOVARTIS drugs in seventy-three countries and four hundred and ninety-six supplementary protection certificates in nineteen countries.

Summary for Novartis

International Patents:	3317
US Patents:	154
Tradenames:	180
Ingredients:	155
NDAs:	216
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	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008		RX	Yes	No	8,828,430*PED				Y
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	AB	RX	Yes	Yes	8,101,599		Y
Novartis	FORADIL CERTIHALER	formoterol fumarate	POWDER;INHALATION	021592-001	Dec 15, 2006		DISCN	No	No

Expired US Patents for Novartis

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015	8,048,451
Novartis	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-007	Jan 8, 1999	5,474,783
Novartis	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-003	Mar 3, 1995	4,572,909
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-007	Apr 21, 2011	6,228,398

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg		2004-04-21
	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
	Ophthalmic Solution	0.003%		2015-12-30
	Tablets	320 mg/12.5 mg and 320 mg/25 mg		2007-02-07
	Transdermal System Extended-release	13.3 mg/24 hr		2013-01-22
	Tablets	90 mg and 360 mg		2015-10-19
	Ophthalmic Solution	0.00%		2009-02-19
	Tablets	5 mg/320 mg		2007-11-26
	Tablets	100 mg and 400 mg		2007-03-12
	Tablets	180 mg		2016-04-28
	Nasal Spray	0.665 mg/ Spray		2009-06-29
	Tablets	10 mg/320 mg		2007-11-09
	Capsules	20 mg and 40 mg		2008-06-04
	Extended-release Capsules	15 mg		2007-05-14
	Otic Suspension	0.3%/0.1%		2012-07-31
	Tablets	10 mg/12.5 mg/160 mg		2009-10-22
	Capsules	5 mg/40 mg and 10 mg/40 mg		2006-11-17
	Extended-release Capsule	30 mg		2010-12-15
	Oral Suspension	300 mg/5 mL		2006-12-26
	Tablets	2.5 mg		2004-07-27
	Ophthalmic Emulsion	0.05%		2014-05-01
	Extended-release capsules	25 mg		2011-09-30
	Delayed-release Tablets	180 mg		2009-06-04
	Tablets	50 mg and 75 mg		2014-01-07
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	Extended-release Capsules	10 mg		2007-05-21
	Extended-release Tablets	100 mg		2005-12-30
	Tablets	60 mg and 120 mg		2004-12-22
	Injection	0.05 mg/mL, 100 mL vial		2008-08-29
	Tablets	40 mg, 80 mg,160 mg		2004-12-28
	Tablets	10 mg		2014-06-18
	Tablets	0.25 mg, 0.5 mg, and 0.75 mg		2013-09-30
	Injection	4 mg/100 mg, 100 mL vial		2012-01-31
	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg		2005-12-02
	Oral Solution	2 mg/mL		2004-11-05
	Tablets	2.5 mg		2006-03-02
	Ophthalmic Solution	10.5%		2012-02-29
	Tablets	5 mg/160 mg		2007-10-22
	Capsules	0.5 mg		2014-09-22
	Tablets	180 mg		2015-10-23
	Ophthalmic	0.50%		2005-12-22
	Tablets	10 mg/160 mg		2007-10-01
	Capsules	400 mg		2014-01-24
	Ophthalmic Suspension	0.3%		2015-12-21
	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
	Capsules	2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg		2004-06-09
	Extended-release Capsules	5mg, 10mg and 20 mg		2007-03-30
	Tablets	150 mg, 300 mg and 600 mg		2006-05-05
	Tablets	125 mg, 250 mg and 500 mg		2004-12-28
	Capsules	150 mg and 200 mg		2013-01-29
	Extended-release Capsule	40 mg		2010-12-20
	Delayed-release Tablets	360 mg		2009-02-02
	Tablets	5 mg and 10 mg		2004-05-27
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	Extended-release capsules	35 mg		2011-09-29
	Extended-release Tablets	80 mg		2007-03-15
	Tablets	12.5 mg and 25 mg		2014-02-04
	Oral Solution	4 mg/5 mL		2004-12-20
	Extended-release Capsules	20 mg, 30 mg and 40 mg		2006-08-21
	Tablets	125 mg, 250 mg, and 500 mg		2011-10-28
	Tablets	250 mg		2011-03-14
	Injection	0.8 mg (base) /mL		2008-06-11

International Patents for Novartis Drugs

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009114521
Taiwan	I498116
Canada	2410201
Austria	502666

Supplementary Protection Certificates for Novartis Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379069	132020000000076	Italy		PRODUCT NAME: SIPONIMOD(MAYZENT ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1414, 20200115
0999825	122013000085	Germany		PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
1294378	SPC/GB10/026	United Kingdom		PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE); REGISTERED: UK EU1/10/612/001 20100315; UK EU1/10/612/002 20100315; UK EU1/10/612/003 20100315; UK EU1/10/612/004 20100315; UK EU1/10/612/005 20100315; UK EU1/10/612/006 20100315
1467728	C01467728/01	Switzerland		PRODUCT NAME: SACUBRITIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015

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