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 one hundred and eighty-five approved drugs.

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

There are two thousand seven hundred and forty-seven patent family members on NOVARTIS drugs in sixty-nine countries and five hundred and twenty supplementary protection certificates in nineteen countries.

Summary for Novartis

International Patents:	2747
US Patents:	103
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

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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	DIAPID	lypressin	SOLUTION;NASAL	016755-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Novartis	SANOREX	mazindol	TABLET;ORAL	017247-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Novartis	LIVOSTIN	levocabastine hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	020219-001	Nov 10, 1993		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	AB	RX	Yes	No	8,410,131*PED	⤷ Try a Trial			Y	⤷ Try a Trial
Novartis	TRIAMINIC-12	chlorpheniramine maleate; phenylpropanolamine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	018115-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
>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	STARLIX	nateglinide	TABLET;ORAL	021204-002	Dec 22, 2000	6,641,841	⤷ Try a Trial
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010	5,559,111	⤷ Try a Trial
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	7,332,481*PED	⤷ Try a Trial
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-002	Sep 10, 1986	4,379,454	⤷ Try a Trial
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-003	Jan 20, 1982	3,471,548	⤷ Try a Trial
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	5,342,625	⤷ Try a Trial
>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	Transdermal System Extended-release	13.3 mg/24 hr	➤ Subscribe	2013-01-22
➤ Subscribe	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg	➤ Subscribe	2016-12-30
➤ Subscribe	Tablets	2.5 mg, 5 mg, and 7.5 mg	➤ Subscribe	2014-12-10
➤ Subscribe	Tablets	100 mg and 400 mg	➤ Subscribe	2007-03-12
➤ Subscribe	Tablets	90 mg and 360 mg	➤ Subscribe	2015-10-19
➤ Subscribe	Tablets	320 mg/12.5 mg and 320 mg/25 mg	➤ Subscribe	2007-02-07
➤ Subscribe	Capsules	20 mg and 40 mg	➤ Subscribe	2008-06-04
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2016-04-28
➤ Subscribe	Tablets	5 mg/320 mg	➤ Subscribe	2007-11-26
➤ Subscribe	Injection	0.8 mg (base) /mL	➤ Subscribe	2008-06-11
➤ Subscribe	Tablets	10 mg/320 mg	➤ Subscribe	2007-11-09
➤ Subscribe	Ophthalmic Solution	0.003%	➤ Subscribe	2015-12-30
➤ Subscribe	Tablets	10 mg/12.5 mg/160 mg	➤ Subscribe	2009-10-22
➤ Subscribe	Tablets	150 mg, 300 mg and 600 mg	➤ Subscribe	2006-05-05
➤ Subscribe	Tablets	50 mg and 75 mg	➤ Subscribe	2014-01-07
➤ Subscribe	Delayed-release Tablets	360 mg	➤ Subscribe	2009-02-02
➤ Subscribe	Tablets	60 mg and 120 mg	➤ Subscribe	2004-12-22
➤ Subscribe	Tablets	40 mg, 80 mg,160 mg	➤ Subscribe	2004-12-28
➤ Subscribe	Extended-release Tablets	100 mg	➤ Subscribe	2005-12-30
➤ Subscribe	Tablets	0.25 mg, 0.5 mg, and 0.75 mg	➤ Subscribe	2013-09-30
➤ Subscribe	Oral Solution	2 mg/mL	➤ Subscribe	2004-11-05
➤ Subscribe	Tablets	10 mg	➤ Subscribe	2014-06-18
➤ Subscribe	Capsules	0.5 mg	➤ Subscribe	2014-09-22
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2006-03-02
➤ Subscribe	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg	➤ Subscribe	2005-12-02
➤ Subscribe	Capsules	400 mg	➤ Subscribe	2014-01-24
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2015-10-23
➤ Subscribe	Tablets	5 mg/160 mg	➤ Subscribe	2007-10-22
➤ Subscribe	Capsules	150 mg and 200 mg	➤ Subscribe	2013-01-29
➤ Subscribe	Tablets	10 mg/160 mg	➤ Subscribe	2007-10-01
➤ Subscribe	Injection	4 mg/100 mg, 100 mL vial	➤ Subscribe	2012-01-31
➤ 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	Nasal Spray	0.665 mg/ Spray	➤ Subscribe	2009-06-29
➤ Subscribe	Tablets	125 mg, 250 mg and 500 mg	➤ Subscribe	2004-12-28
➤ Subscribe	Oral Suspension	300 mg/5 mL	➤ Subscribe	2006-12-26
➤ Subscribe	Tablets	12.5 mg and 25 mg	➤ Subscribe	2014-02-04
➤ Subscribe	Delayed-release Tablets	180 mg	➤ Subscribe	2009-06-04
➤ Subscribe	Tablets	250 mg	➤ Subscribe	2011-03-14
➤ Subscribe	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg	➤ Subscribe	2004-04-21
➤ Subscribe	Tablets	125 mg, 250 mg, and 500 mg	➤ Subscribe	2011-10-28

International Patents for Novartis Drugs

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Country	Patent Number	Estimated Expiration
Japan	5570806	⤷ Try a Trial
European Patent Office	3124018	⤷ Try a Trial
New Zealand	718812	⤷ Try a Trial
European Patent Office	1441737	⤷ Try a Trial
Russian Federation	2599785	⤷ Try a Trial
Croatia	P20170631	⤷ Try a Trial
>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
1429780	SPC/GB12/058	United Kingdom	⤷ Try a Trial	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
2269603	122015000094	Germany	⤷ Try a Trial	PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723
2435024	PA2021511,C2435024	Lithuania	⤷ Try a Trial	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
1638574	2017/061	Ireland	⤷ Try a Trial	PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1507558	18/2012	Austria	⤷ Try a Trial	PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - 060 20111122; FIRST REGISTRATION: LI 61678 01-61678 05 20110705
0398460	04C0022	France	⤷ Try a Trial	PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Similar Applicant Names

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Summary for Novartis

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Similar Applicant Names

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