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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 eighty-five 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:	185
Tradenames:	186
Ingredients:	156
NDAs:	222
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 Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012		RX	Yes	Yes
Novartis Pharms Corp	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No	8,178,582		Y
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008		RX	Yes	No
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003	AB	RX	Yes	No

Expired US Patents for Novartis

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	ARRANON	nelarabine	INJECTABLE;IV (INFUSION)	021877-001	Oct 28, 2005	5,747,472
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	Jul 14, 1995	6,007,840
Novartis	TEGRETOL	carbamazepine	TABLET;ORAL	016608-001	Approved Prior to Jan 1, 1982	4,409,212
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-001	May 26, 2005	5,908,850

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	4 mg/100 mg, 100 mL vial		2012-01-31
	Tablets	100 mg and 400 mg		2007-03-12
	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
	Transdermal System Extended-release	13.3 mg/24 hr		2013-01-22
	Extended-release Capsules	10 mg		2007-05-21
	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
	Ophthalmic Solution	0.00%		2009-02-19
	Tablets	90 mg and 360 mg		2015-10-19
	Tablets	125 mg, 250 mg, and 500 mg		2011-10-28
	Extended-release Tablets	80 mg		2007-03-15
	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg		2005-12-02
	Ophthalmic Suspension	0.3%		2015-12-21
	Ophthalmic Solution	10.5%		2012-02-29
	Tablets	2.5 mg		2006-03-02
	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	40 mg, 80 mg,160 mg		2004-12-28
	Tablets	180 mg		2015-10-23

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
9,290,533	.beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B
8,877,771	Treatment of solid tumors with rapamycin derivatives
6,638,495	Stabilized preparation for use in metered dose inhalers
6,596,750	Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators

International Patents for Novartis Drugs

Country	Document Number	Estimated Expiration
Hong Kong	1150746
Brazil	PI0720264
Japan	4824754
Morocco	28179

Supplementary Protection Certificates for Novartis Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
2009 00010	Denmark		PRODUCT NAME: ALISKIREN, SOM DETS FRIE BASE ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, SAMT HYDROCHLORTHIAZID ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, HERUNDER ALISKIREN HEMIFUMARAT OG HYDROCHLORTHIAZID; NAT. REG. NO/DATE: EU/1/08/491/001-080 20090116; FIRST REG. NO/DATE: CH 58935 01-04 20081028
00221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
00445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016

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