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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 twenty approved drugs.

There are one hundred and seventy-five US patents protecting NOVARTIS drugs.

Summary for NOVARTIS

US Patents:	175
Tradenames:	185
Ingredients:	154
NDAs:	220
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 Pharms Corp	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-001	Dec 31, 1992	AB	RX	Yes	No
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-002	Jul 7, 2015		RX	Yes	No	8,796,331
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012		RX	Yes	No	5,665,772*PED				Y

Expired US Patents for NOVARTIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	PATADAY	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	5,116,863*PED
Novartis Pharms Corp	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	5,607,942*PED
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-004	Feb 27, 1996	4,849,226

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Capsule	40 mg		2010-12-20
	Tablets	10 mg/160 mg		2007-10-01
	Ophthalmic Solution	10.5%		2012-02-29
	Injection	0.8 mg (base) /mL		2008-06-11
	Extended-release capsules	35 mg		2011-09-29
	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
	Ophthalmic Solution	0.10%		2006-07-17
	Tablets	150 mg, 300 mg and 600 mg		2006-05-05
	Extended-release Capsules	20 mg, 30 mg and 40 mg		2006-08-21
	Tablets	125 mg, 250 mg and 500 mg		2004-12-28
	Ophthalmic Solution	0.00%		2009-02-19
	Delayed-release Tablets	360 mg		2009-02-02
	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg		2004-04-21
	Tablets	5 mg and 10 mg		2004-05-27
	Nasal Spray	0.665 mg/ Spray		2009-06-29
	Extended-release Tablets	80 mg		2007-03-15
	Transdermal System Extended-release	13.3 mg/24 hr		2013-01-22
	Tablets	0.25 mg, 0.5 mg, and 0.75 mg		2013-09-30
	Otic Suspension	0.3%/0.1%		2012-07-31
	Tablets	125 mg, 250 mg, and 500 mg		2011-10-28
	Inhalation Solution	300 mg/5 mL		2009-06-29
	Tablets	100 mg and 400 mg		2007-03-12
	Tablets	180 mg		2015-10-23
	Tablets	2.5 mg, 5 mg, and 7.5 mg		2014-12-10
	Ophthalmic Emulsion	0.05%		2014-05-01
	Capsules	20 mg and 40 mg		2008-06-04
	Extended-release Capsules	15 mg		2007-05-14
	Tablets	50 mg and 75 mg		2014-01-07
	Tablets	320 mg/12.5 mg and 320 mg/25 mg		2007-02-07
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	Capsules	5 mg/40 mg and 10 mg/40 mg		2006-11-17
	Extended-release Capsule	30 mg		2010-12-15
	Tablets	250 mg		2011-03-14
	Tablets	5 mg/320 mg		2007-11-26
	Ophthalmic Solution	0.003%		2015-12-30
	Injection	0.05 mg/mL, 100 mL vial		2008-08-29
	Extended-release capsules	25 mg		2011-09-30
	Tablets	10 mg/320 mg		2007-11-09
	Ophthalmic Solution	0.20%		2008-09-08
	Injection	4 mg/100 mg, 100 mL vial		2012-01-31
	Extended-release Capsules	10 mg		2007-05-21
	Tablets	10 mg/12.5 mg/160 mg		2009-10-22
	Ophthalmic Solution	0.7%		2015-09-10
	Oral Suspension	300 mg/5 mL		2006-12-26
	Tablets	40 mg, 80 mg,160 mg		2004-12-28
	Tablets	2.5 mg		2004-07-27
	Ophthalmic	0.50%		2005-12-22
	Delayed-release Tablets	180 mg		2009-06-04
	Oral Solution	2 mg/mL		2004-11-05
	Tablets	60 mg and 120 mg		2004-12-22
	Ophthalmic Suspension	0.3%		2015-12-21
	Extended-release Tablets	100 mg		2005-12-30
	Capsules	0.5 mg		2014-09-22
	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg		2016-12-30
	Tablets	90 mg and 360 mg		2015-10-19
	Tablets	10 mg		2014-06-18
	Tablets	2.5 mg		2006-03-02
	Capsules	400 mg		2014-01-24
	Tablets	180 mg		2016-04-28
	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg		2005-12-02
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	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	12.5 mg and 25 mg		2014-02-04
	Tablets	5 mg/160 mg		2007-10-22
	Oral Solution	4 mg/5 mL		2004-12-20
	Capsules	150 mg and 200 mg		2013-01-29

Premature patent expirations for NOVARTIS

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

International Patents for NOVARTIS Drugs

Country	Document Number	Estimated Expiration
China	1650863
Taiwan	I498116
Hungary	0400691

Supplementary Protection Certificates for NOVARTIS Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/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 20100311; UK EU1/10/612/002 20100311; UK EU1/10/612/003 20100311; UK EU1/10/612/004 20100311; UK EU1/10/612/005 20100311; UK EU1/10/612/006 20100311
00385	Netherlands		PRODUCT NAME: ALISKIREN, DESGEWENST IN DE VORM; REGISTRATION NO/DATE: 58935 01-04 20081028
2008012, C1047694	Lithuania		PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610

Similar Applicant Names

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

• Nova Labs Ltd
• Novartis
• Novartis Pharm