NOVARTIS Company Profile

What is the competitive landscape for NOVARTIS, and what generic alternatives to NOVARTIS drugs are available?

NOVARTIS has one hundred and eighty-five approved drugs.

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

There are three thousand six hundred and one patent family members on NOVARTIS drugs in seventy-four countries and five hundred and twenty-eight supplementary protection certificates in nineteen countries.

Summary for NOVARTIS

International Patents:	3601
US Patents:	138
Tradenames:	154
Ingredients:	139
NDAs:	185
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	IZBA	travoprost	SOLUTION/DROPS;OPHTHALMIC	204822-001	May 15, 2014		DISCN	Yes	No	8,722,735		Y
Novartis	SANOREX	mazindol	TABLET;ORAL	017247-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	8,580,304*PED				Y
Novartis	VISKAZIDE	hydrochlorothiazide; pindolol	TABLET;ORAL	018872-002	Jul 22, 1987		DISCN	No	No
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-001	May 29, 2013		RX	Yes	No	8,580,304*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	SOLUTION;ORAL	217513-001	Mar 16, 2023		RX	Yes	Yes	8,835,443
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008		RX	Yes	No	8,052,993*PED				Y

Expired US Patents for NOVARTIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-002	Oct 21, 1988	5,753,618*PED
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993	5,354,772*PED
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	8,475,839*PED
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-001	Aug 20, 2001	4,939,130*PED
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-004	Aug 14, 2002	5,972,990*PED
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998	5,922,338*PED
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	7,790,704*PED

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Transdermal System Extended-release	13.3 mg/24 hr		2013-01-22
	Tablets	0.25 mg, 0.5 mg, and 0.75 mg		2013-09-30
	Tablets	10 mg		2014-06-18
	Tablets	100 mg and 400 mg		2007-03-12
	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	20 mg and 40 mg		2008-06-04
	Tablets	180 mg		2015-10-23
	Tablets	5 mg/160 mg		2007-10-22
	Injection	0.8 mg (base) /mL		2008-06-11
	Tablets	10 mg/160 mg		2007-10-01
	Ophthalmic Solution	0.003%		2015-12-30
	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	40 mg, 80 mg,160 mg		2004-12-28
	Tablets	12.5 mg and 25 mg		2014-02-04
	Delayed-release Tablets	180 mg		2009-06-04
	Oral Solution	2 mg/mL		2004-11-05
	Tablets	250 mg		2011-03-14
	Tablets	125 mg, 250 mg, and 500 mg		2011-10-28
	Capsules	0.5 mg		2014-09-22
	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
	Capsules	400 mg		2014-01-24
	Tablets	90 mg and 360 mg		2015-10-19
	Tablets	320 mg/12.5 mg and 320 mg/25 mg		2007-02-07
	Capsules	150 mg and 200 mg		2013-01-29
	Tablets	180 mg		2016-04-28
	Tablets	5 mg/320 mg		2007-11-26
	Injection	4 mg/100 mg, 100 mL vial		2012-01-31
	Tablets	10 mg/320 mg		2007-11-09
	Ophthalmic	0.50%		2005-12-22
	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
	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg		2004-04-21
	Tablets	60 mg and 120 mg		2004-12-22
	Extended-release Tablets	100 mg		2005-12-30

International Patents for NOVARTIS Drugs

Country	Patent Number	Estimated Expiration
Japan	2004147666
European Patent Office	2332915
Denmark	2287156
Czech Republic	20014301
European Patent Office	1663155
Taiwan	200403060
European Patent Office	2957568

Supplementary Protection Certificates for NOVARTIS Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2091918	217 5020-2015	Slovakia		PRODUCT NAME: CERITINIB; REGISTRATION NO/DATE: EU/1/15/999 20150508
2435024	PA2021511,C2435024	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209
2340828	2021C/502	Belgium		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3 . X H2O, WAARBIJ X 0 TOT 3 IS; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 (C(2015) 8288) 20151123
1429780	SPC/GB12/058	United Kingdom		PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
1183240	C300437	Netherlands		PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1104436	C300286	Netherlands		PRODUCT NAME: TELBIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
2435024	CA 2021 00014	Denmark		PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210

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
• Novartis Pharms Corp
• Novast Labs