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	PIQRAY	alpelisib	TABLET;ORAL	212526-001	May 24, 2019		RX	Yes	No
Novartis	CEDILANID-D	deslanoside	INJECTABLE;INJECTION	009282-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010		RX	Yes	No	8,501,760*PED				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

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for Novartis Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	1605978
Lithuania	C2331547
San Marino	T201500017

Supplementary Protection Certificates for Novartis Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4095130	122024000038	Germany		PRODUCT NAME: (177LU)LUTETIUMVIPIVOTIDTETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703 20221209
1761528	CA 2014 00055	Denmark		PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140630
1280520	CA 2015 00017	Denmark		PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720

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