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 fifteen approved drugs.

There are one hundred and fifty-four US patents protecting NOVARTIS drugs.

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

Summary for Novartis

International Patents:	3904
US Patents:	154
Tradenames:	181
Ingredients:	156
NDAs:	215
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	SERENTIL	mesoridazine besylate	TABLET;ORAL	016774-003	Approved Prior to Jan 1, 1982		DISCN	No	No		See Plans and Pricing				See Plans and Pricing
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-002	May 24, 2019		RX	Yes	No	8,227,462	See Plans and Pricing	Y	Y		See Plans and Pricing
Novartis	EGATEN	triclabendazole	TABLET;ORAL	208711-001	Feb 13, 2019		RX	Yes	Yes		See Plans and Pricing				See Plans and Pricing
Novartis	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007	AB	RX	Yes	Yes		See Plans and Pricing				See Plans and Pricing
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010		DISCN	No	No	8,613,949	See Plans and Pricing	Y			See Plans and Pricing
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	AB	RX	Yes	No	9,006,224	See Plans and Pricing				See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for Novartis

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-008	Apr 21, 2011	6,730,325	See Plans and Pricing
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,796,307	See Plans and Pricing
Novartis	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999	4,695,578*PED	See Plans and Pricing
Novartis Pharms	FEMARA	letrozole	TABLET;ORAL	020726-001	Jul 25, 1997	4,978,672	See Plans and Pricing
Novartis	LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020192-001	Dec 30, 1992	4,755,534*PED	See Plans and Pricing
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-003	Dec 28, 1983	3,483,221	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Extended-release Tablets	100 mg	➤ Subscribe	2005-12-30
➤ Subscribe	Extended-release capsules	35 mg	➤ Subscribe	2011-09-29
➤ Subscribe	Tablets	60 mg and 120 mg	➤ Subscribe	2004-12-22
➤ Subscribe	Oral Solution	4 mg/5 mL	➤ Subscribe	2004-12-20
➤ Subscribe	Tablets	10 mg	➤ Subscribe	2014-06-18
➤ Subscribe	Extended-release Capsules	20 mg, 30 mg and 40 mg	➤ Subscribe	2006-08-21
➤ Subscribe	Tablets	0.25 mg, 0.5 mg, and 0.75 mg	➤ Subscribe	2013-09-30
➤ Subscribe	Injection	0.8 mg (base) /mL	➤ Subscribe	2008-06-11
➤ Subscribe	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg	➤ Subscribe	2005-12-02
➤ Subscribe	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg	➤ Subscribe	2004-04-21
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2006-03-02
➤ Subscribe	Ophthalmic Solution	0.003%	➤ Subscribe	2015-12-30
➤ Subscribe	Tablets	5 mg/160 mg	➤ Subscribe	2007-10-22
➤ Subscribe	Transdermal System Extended-release	13.3 mg/24 hr	➤ Subscribe	2013-01-22
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2015-10-23
➤ Subscribe	Ophthalmic	0.50%	➤ Subscribe	2005-12-22
➤ Subscribe	Tablets	10 mg/160 mg	➤ Subscribe	2007-10-01
➤ Subscribe	Tablets	100 mg and 400 mg	➤ Subscribe	2007-03-12
➤ Subscribe	Ophthalmic Suspension	0.3%	➤ Subscribe	2015-12-21
➤ Subscribe	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	➤ Subscribe	2009-09-14
➤ Subscribe	Capsules	20 mg and 40 mg	➤ Subscribe	2008-06-04
➤ Subscribe	Tablets	150 mg, 300 mg and 600 mg	➤ Subscribe	2006-05-05
➤ Subscribe	Extended-release Capsules	15 mg	➤ Subscribe	2007-05-14
➤ Subscribe	Tablets	125 mg, 250 mg and 500 mg	➤ Subscribe	2004-12-28
➤ Subscribe	Capsules	5 mg/40 mg and 10 mg/40 mg	➤ Subscribe	2006-11-17
➤ Subscribe	Delayed-release Tablets	360 mg	➤ Subscribe	2009-02-02
➤ Subscribe	Extended-release Capsule	30 mg	➤ Subscribe	2010-12-15
➤ Subscribe	Tablets	5 mg and 10 mg	➤ Subscribe	2004-05-27
➤ Subscribe	Ophthalmic Emulsion	0.05%	➤ Subscribe	2014-05-01
➤ Subscribe	Extended-release Tablets	80 mg	➤ Subscribe	2007-03-15
➤ Subscribe	Extended-release capsules	25 mg	➤ Subscribe	2011-09-30
➤ Subscribe	Tablets	12.5 mg and 25 mg	➤ Subscribe	2014-02-04
➤ Subscribe	Injection	1 mg/mL, 50 mL vials	➤ Subscribe	2011-12-16
➤ Subscribe	Tablets	125 mg, 250 mg, and 500 mg	➤ Subscribe	2011-10-28
➤ Subscribe	Extended-release Capsules	10 mg	➤ Subscribe	2007-05-21
➤ Subscribe	Tablets	250 mg	➤ Subscribe	2011-03-14
➤ Subscribe	Injection	0.05 mg/mL, 100 mL vial	➤ Subscribe	2008-08-29
➤ Subscribe	Tablets	2.5 mg, 5 mg, and 7.5 mg	➤ Subscribe	2014-12-10
➤ Subscribe	Tablets	40 mg, 80 mg,160 mg	➤ Subscribe	2004-12-28
➤ Subscribe	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg	➤ Subscribe	2016-12-30
➤ Subscribe	Injection	4 mg/100 mg, 100 mL vial	➤ Subscribe	2012-01-31
➤ Subscribe	Tablets	320 mg/12.5 mg and 320 mg/25 mg	➤ Subscribe	2007-02-07
➤ Subscribe	Oral Solution	2 mg/mL	➤ Subscribe	2004-11-05
➤ Subscribe	Tablets	90 mg and 360 mg	➤ Subscribe	2015-10-19
➤ Subscribe	Ophthalmic Solution	0.00%	➤ Subscribe	2009-02-19
➤ Subscribe	Tablets	5 mg/320 mg	➤ Subscribe	2007-11-26
➤ Subscribe	Capsules	0.5 mg	➤ Subscribe	2014-09-22
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2016-04-28
➤ Subscribe	Nasal Spray	0.665 mg/ Spray	➤ Subscribe	2009-06-29
➤ Subscribe	Tablets	10 mg/320 mg	➤ Subscribe	2007-11-09
➤ Subscribe	Capsules	400 mg	➤ Subscribe	2014-01-24
➤ Subscribe	Otic Suspension	0.3%/0.1%	➤ Subscribe	2012-07-31
➤ Subscribe	Tablets	10 mg/12.5 mg/160 mg	➤ Subscribe	2009-10-22
➤ Subscribe	Capsules	2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg	➤ Subscribe	2004-06-09
➤ Subscribe	Oral Suspension	300 mg/5 mL	➤ Subscribe	2006-12-26
➤ Subscribe	Extended-release Capsules	5mg, 10mg and 20 mg	➤ Subscribe	2007-03-30
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2004-07-27
➤ Subscribe	Capsules	150 mg and 200 mg	➤ Subscribe	2013-01-29
➤ Subscribe	Delayed-release Tablets	180 mg	➤ Subscribe	2009-06-04
➤ Subscribe	Extended-release Capsule	40 mg	➤ Subscribe	2010-12-20
➤ Subscribe	Tablets	50 mg and 75 mg	➤ Subscribe	2014-01-07
➤ Subscribe	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24

International Patents for Novartis Drugs

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Country	Patent Number	Estimated Expiration
South Korea	101809484	See Plans and Pricing
South Korea	102134585	See Plans and Pricing
Eurasian Patent Organization	020840	See Plans and Pricing
Australia	2008340354	See Plans and Pricing
Japan	2010538004	See Plans and Pricing
South Korea	20170137101	See Plans and Pricing
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for Novartis Drugs

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	15/2021	Austria	See Plans and Pricing	PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
0999825	CA 2013 00055	Denmark	See Plans and Pricing	PRODUCT NAME: NEPAFENAC (3 MG/ML), HERUNDER NEPAFENAC I KOMBINATION MED GLACTOMANNANPOLYMERER, ISAER 3 MG/ML NEPAFENAC I KOMBINATION MED GALACTOMANNANPOLYMERER, SAMT OFTALMISKE SAMMENSAETNINGER DERAF; REG. NO/DATE: EU1/07/433/002 20130503
2379069	301046	Netherlands	See Plans and Pricing	PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200115
3143995	300992	Netherlands	See Plans and Pricing	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
1294378	C300451	Netherlands	See Plans and Pricing	PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
3342411	2020C/504	Belgium	See Plans and Pricing	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description