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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-two approved drugs.

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

There are three thousand six hundred and fifty-two patent family members on NOVARTIS drugs in seventy-seven countries and three hundred and sixty-three supplementary protection certificates in fifteen countries.

Summary for NOVARTIS

International Patents:	3652
US Patents:	177
Tradenames:	186
Ingredients:	156
NDAs:	222
Drug Master File Entries:	1

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	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-001	Apr 30, 2009	AB	RX	Yes	No	8,475,839*PED				Y
Novartis Pharms Corp	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013		RX	Yes	Yes	6,316,441
Novartis	VASOCON-A	antazoline phosphate; naphazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	018746-002	Jul 11, 1994		DISCN	No	No
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000	AB	RX	Yes	Yes	6,559,188		Y

Expired US Patents for NOVARTIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	6,258,808
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-001	Jul 28, 1988	3,652,762
Novartis	VIVELLE-DOT	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020538-008	Jan 8, 1999	5,656,286
Novartis	MYFORTIC	mycophenolic acid	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	6,172,107

Paragraph IV (Patent) Challenges for NOVARTIS drugs

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

Premature patent expirations for NOVARTIS

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

Non-Orange Book US Patents for NOVARTIS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,912,205	Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors
8,642,759	Benzene sulfonamide thiazole and oxazole compounds
6,242,442	Brinzolamide and brimonidine for treating ocular conditions
7,151,106	Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use

International Patents for NOVARTIS Drugs

Country	Document Number	Estimated Expiration
Slovenia	1318980
Austria	361916
Japan	2013542257
Spain	2270948

Supplementary Protection Certificates for NOVARTIS Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015041	Lithuania		PRODUCT NAME: EVEROLIMUSUM; REGISTRATION NO/DATE: EU/1/09/538/001, EU/1/09/538/003, EU/1/09/538/004, EU/1/09/538/006-010 20120723
2009	Austria		PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
2009 00009	Denmark
710	Luxembourg		91710, EXPIRES: 20250614

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
• Novartis Pharms