NOVARTIS Company Profile

What is the competitive landscape for NOVARTIS, and when can generic versions of NOVARTIS drugs launch?

NOVARTIS has one hundred and eighty-seven approved drugs.

There are one hundred and thirteen US patents protecting NOVARTIS drugs.

There are two thousand eight hundred and seventy-one patent family members on NOVARTIS drugs in sixty-nine countries and five hundred and thirty supplementary protection certificates in nineteen countries.

Summary for NOVARTIS

International Patents:	2871
US Patents:	113
Tradenames:	155
Ingredients:	139
NDAs:	187
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	TAFINLAR	dabrafenib mesylate	TABLET, FOR SUSPENSION;ORAL	217514-001	Mar 16, 2023		RX	Yes	Yes	8,415,345*PED				Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-005	Feb 27, 1996		DISCN	Yes	No
Novartis	VISKAZIDE	hydrochlorothiazide; pindolol	TABLET;ORAL	018872-001	Jul 22, 1987		DISCN	No	No
Novartis	PLUVICTO	lutetium lu-177 vipivotide tetraxetan	SOLUTION;INTRAVENOUS	215833-001	Mar 23, 2022		RX	Yes	Yes	10,406,240		Y	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	6,007,840
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008	7,790,704*PED
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	6,007,840
Novartis	AREDIA	pamidronate disodium	INJECTABLE;INJECTION	020036-004	May 6, 1993	4,711,880
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011	8,067,437

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	250 mg		2011-03-14
	Tablets	125 mg, 250 mg, and 500 mg		2011-10-28
	Transdermal System Extended-release	13.3 mg/24 hr		2013-01-22
	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg		2016-12-30
	Tablets	2.5 mg, 5 mg, and 7.5 mg		2014-12-10
	Tablets	100 mg and 400 mg		2007-03-12
	Tablets	90 mg and 360 mg		2015-10-19
	Tablets	320 mg/12.5 mg and 320 mg/25 mg		2007-02-07
	Capsules	20 mg and 40 mg		2008-06-04
	Tablets	180 mg		2016-04-28
	Tablets	5 mg/320 mg		2007-11-26
	Injection	0.8 mg (base) /mL		2008-06-11
	Tablets	10 mg/320 mg		2007-11-09
	Ophthalmic Solution	0.003%		2015-12-30
	Tablets	10 mg/12.5 mg/160 mg		2009-10-22
	Tablets	150 mg, 300 mg and 600 mg		2006-05-05
	Tablets	50 mg and 75 mg		2014-01-07
	Delayed-release Tablets	360 mg		2009-02-02
	Tablets	40 mg, 80 mg,160 mg		2004-12-28
	Tablets	60 mg and 120 mg		2004-12-22
	Extended-release Tablets	100 mg		2005-12-30
	Oral Solution	2 mg/mL		2004-11-05
	Tablets	0.25 mg, 0.5 mg, and 0.75 mg		2013-09-30
	Tablets	10 mg		2014-06-18
	Capsules	0.5 mg		2014-09-22
	Tablets	2.5 mg		2006-03-02
	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg		2005-12-02
	Capsules	400 mg		2014-01-24
	Tablets	180 mg		2015-10-23
	Tablets	5 mg/160 mg		2007-10-22
	Capsules	150 mg and 200 mg		2013-01-29
	Tablets	10 mg/160 mg		2007-10-01
	Injection	4 mg/100 mg, 100 mL vial		2012-01-31
	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
	Nasal Spray	0.665 mg/ Spray		2009-06-29
	Tablets	125 mg, 250 mg and 500 mg		2004-12-28
	Oral Suspension	300 mg/5 mL		2006-12-26
	Tablets	12.5 mg and 25 mg		2014-02-04
	Delayed-release Tablets	180 mg		2009-06-04

International Patents for NOVARTIS Drugs

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	035686
Israel	294658
Croatia	P20170021
Japan	6105653
South Korea	20140012218

Supplementary Protection Certificates for NOVARTIS Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638574	2017/061	Ireland		PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
1613288	SPC/GB11/045	United Kingdom		PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
1272477	2015/049	Ireland		PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/999 20150506
1294378	2010C/018	Belgium		PRODUCT NAME: ELTROMBOPAG, OPTIONNELLEMENT SOUS FORME DE SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS UN HYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/10/612/001 20100315

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
• Novartis Pharms