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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-one approved drugs.

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

There are three thousand four hundred and forty-one patent family members on NOVARTIS drugs in seventy-seven countries and four hundred and eleven supplementary protection certificates in eighteen countries.

Summary for NOVARTIS

International Patents:	3441
US Patents:	161
Tradenames:	185
Ingredients:	156
NDAs:	221
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	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-003	Jan 14, 2000	AB	RX	Yes	Yes
Novartis	CEDILANID-D	deslanoside	INJECTABLE;INJECTION	009282-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	PBZ-SR	tripelennamine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	010533-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	LAMISIL	terbinafine hydrochloride	GRANULE;ORAL	022071-002	Sep 28, 2007		DISCN	Yes	No

Expired US Patents for NOVARTIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-001	Apr 26, 1996	5,246,937*PED
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	6,262,022
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-002	Apr 18, 2003	5,521,184*PED
Novartis	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995	4,572,909

Paragraph IV (Patent) Challenges for NOVARTIS drugs

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

International Patents for NOVARTIS Drugs

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	03026671
South Korea	101537200
European Patent Office	2269603
Mexico	2008015076

Supplementary Protection Certificates for NOVARTIS Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
2091918	C20150037 00157	Estonia		PRODUCT NAME: TSERITINIIB;REG NO/DATE: EU/1/15/999 08.05.2015
0678503	C00678503/04	Switzerland		PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
1104436	CA 2007 00038	Denmark		PRODUCT NAME: TELBIVUDINE

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