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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 twenty-one approved drugs.

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

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

Summary for NOVARTIS

International Patents:	3514
US Patents:	174
Tradenames:	185
Ingredients:	156
NDAs:	221
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	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-002	Oct 21, 1988	AP	RX	Yes	Yes		Start Trial				Start Trial
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes		Start Trial				Start Trial
Novartis	INFLAMASE FORTE	prednisolone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	080751-002	Approved Prior to Jan 1, 1982		DISCN	No	No		Start Trial				Start Trial
Novartis	TREST	methixene hydrochloride	TABLET;ORAL	013420-001	Approved Prior to Jan 1, 1982		DISCN	No	No		Start Trial				Start Trial
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012		RX	Yes	No	8,617,598*PED	Start Trial			Y	Start Trial
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-002	Jun 20, 2007	AB	RX	Yes	No	6,395,728	Start Trial	Y			Start Trial
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes	9,006,224	Start Trial				Start 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	VIVELLE-DOT	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020538-006	Jan 8, 1999	5,958,446	Start Trial
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-004	Jun 20, 2007	6,395,728	Start Trial
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-002	Feb 27, 1996	4,812,313	Start Trial
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	5,399,578*PED	Start Trial
Novartis	EMBOLEX	dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride	INJECTABLE;INJECTION	018885-001	Nov 30, 1984	4,451,458	Start Trial
Novartis	RECLAST	zoledronic acid	INJECTABLE;INTRAVENOUS	021817-001	Apr 16, 2007	4,939,130*PED	Start Trial
Novartis	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	5,747,472	Start 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	Tablets	10 mg/160 mg	➤ Subscribe	2007-10-01
➤ Subscribe	Capsules	5 mg/40 mg and 10 mg/40 mg	➤ Subscribe	2006-11-17
➤ Subscribe	Ophthalmic Suspension	0.3%	➤ Subscribe	2015-12-21
➤ Subscribe	Extended-release Capsule	30 mg	➤ Subscribe	2010-12-15
➤ 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	Ophthalmic Emulsion	0.05%	➤ Subscribe	2014-05-01
➤ Subscribe	Tablets	150 mg, 300 mg and 600 mg	➤ Subscribe	2006-05-05
➤ Subscribe	Extended-release capsules	25 mg	➤ Subscribe	2011-09-30
➤ Subscribe	Tablets	125 mg, 250 mg and 500 mg	➤ Subscribe	2004-12-28
➤ Subscribe	Injection	1 mg/mL, 50 mL vials	➤ Subscribe	2011-12-16
➤ Subscribe	Delayed-release Tablets	360 mg	➤ Subscribe	2009-02-02
➤ Subscribe	Extended-release Capsules	10 mg	➤ Subscribe	2007-05-21
➤ Subscribe	Injection	0.05 mg/mL, 100 mL vial	➤ Subscribe	2008-08-29
➤ Subscribe	Tablets	5 mg and 10 mg	➤ Subscribe	2004-05-27
➤ Subscribe	Extended-release Tablets	80 mg	➤ Subscribe	2007-03-15
➤ Subscribe	Tablets	40 mg, 80 mg,160 mg	➤ Subscribe	2004-12-28
➤ Subscribe	Injection	4 mg/100 mg, 100 mL vial	➤ Subscribe	2012-01-31
➤ Subscribe	Tablets	12.5 mg and 25 mg	➤ Subscribe	2014-02-04
➤ Subscribe	Tablets	125 mg, 250 mg, and 500 mg	➤ Subscribe	2011-10-28
➤ Subscribe	Oral Solution	2 mg/mL	➤ Subscribe	2004-11-05
➤ Subscribe	Ophthalmic Solution	10.5%	➤ Subscribe	2012-02-29
➤ Subscribe	Tablets	250 mg	➤ Subscribe	2011-03-14
➤ Subscribe	Tablets	2.5 mg, 5 mg, and 7.5 mg	➤ Subscribe	2014-12-10
➤ Subscribe	Capsules	0.5 mg	➤ Subscribe	2014-09-22
➤ Subscribe	Ophthalmic Solution	0.10%	➤ Subscribe	2006-07-17
➤ Subscribe	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg	➤ Subscribe	2016-12-30
➤ Subscribe	Tablets	320 mg/12.5 mg and 320 mg/25 mg	➤ Subscribe	2007-02-07
➤ Subscribe	Capsules	400 mg	➤ Subscribe	2014-01-24
➤ Subscribe	Ophthalmic Solution	0.00%	➤ Subscribe	2009-02-19
➤ Subscribe	Tablets	90 mg and 360 mg	➤ Subscribe	2015-10-19
➤ Subscribe	Tablets	5 mg/320 mg	➤ Subscribe	2007-11-26
➤ 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	Nasal Spray	0.665 mg/ Spray	➤ Subscribe	2009-06-29
➤ Subscribe	Extended-release Capsules	5mg, 10mg and 20 mg	➤ Subscribe	2007-03-30
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2016-04-28
➤ Subscribe	Tablets	10 mg/320 mg	➤ Subscribe	2007-11-09
➤ Subscribe	Capsules	150 mg and 200 mg	➤ Subscribe	2013-01-29
➤ Subscribe	Otic Suspension	0.3%/0.1%	➤ Subscribe	2012-07-31
➤ Subscribe	Extended-release Capsule	40 mg	➤ Subscribe	2010-12-20
➤ Subscribe	Tablets	10 mg/12.5 mg/160 mg	➤ Subscribe	2009-10-22
➤ Subscribe	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24
➤ Subscribe	Oral Suspension	300 mg/5 mL	➤ Subscribe	2006-12-26
➤ Subscribe	Extended-release capsules	35 mg	➤ Subscribe	2011-09-29
➤ Subscribe	Oral Solution	4 mg/5 mL	➤ Subscribe	2004-12-20
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2004-07-27
➤ Subscribe	Delayed-release Tablets	180 mg	➤ Subscribe	2009-06-04
➤ Subscribe	Extended-release Capsules	20 mg, 30 mg and 40 mg	➤ Subscribe	2006-08-21
➤ Subscribe	Injection	0.8 mg (base) /mL	➤ Subscribe	2008-06-11
➤ Subscribe	Tablets	50 mg and 75 mg	➤ Subscribe	2014-01-07
➤ Subscribe	Extended-release Tablets	100 mg	➤ Subscribe	2005-12-30
➤ Subscribe	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg	➤ Subscribe	2004-04-21
➤ Subscribe	Ophthalmic Solution	0.003%	➤ Subscribe	2015-12-30
➤ Subscribe	Tablets	60 mg and 120 mg	➤ Subscribe	2004-12-22
➤ Subscribe	Tablets	10 mg	➤ Subscribe	2014-06-18
➤ Subscribe	Transdermal System Extended-release	13.3 mg/24 hr	➤ Subscribe	2013-01-22
➤ Subscribe	Ophthalmic Solution	0.20%	➤ Subscribe	2008-09-08
➤ Subscribe	Tablets	0.25 mg, 0.5 mg, and 0.75 mg	➤ Subscribe	2013-09-30
➤ Subscribe	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg	➤ Subscribe	2005-12-02
➤ Subscribe	Tablets	100 mg and 400 mg	➤ Subscribe	2007-03-12
➤ Subscribe	Ophthalmic Solution	0.7%	➤ Subscribe	2015-09-10
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2006-03-02
➤ Subscribe	Tablets	5 mg/160 mg	➤ Subscribe	2007-10-22
➤ Subscribe	Capsules	20 mg and 40 mg	➤ Subscribe	2008-06-04
➤ Subscribe	Ophthalmic	0.50%	➤ Subscribe	2005-12-22
➤ Subscribe	Extended-release Capsules	15 mg	➤ Subscribe	2007-05-14
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2015-10-23

International Patents for NOVARTIS Drugs

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Country	Patent Number	Estimated Expiration
Australia	1295299	Start Trial
Russian Federation	2334513	Start Trial
Germany	102004016947	Start Trial
Norway	20131547	Start Trial
European Patent Office	2586426	Start Trial
Israel	174732	Start Trial
Slovakia	7662001	Start 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
0663916	CA 2004 00020	Denmark	Start Trial	PRODUCT NAME: EVEROLIMUS
1380301	CA 2009 00017	Denmark	Start Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2091918	54/2015	Austria	Start Trial	PRODUCT NAME: CERITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/999 (MITTEILUNG) 20180508
1441735	08C0026	France	Start Trial	PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
2269604	PA2016035	Lithuania	Start Trial	PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
1613288	C 2011 005	Romania	Start Trial	PRODUCT NAME: FINGOLIMOD SI SARURILE SALE ACCEPTABILE FARMACEUTIC INSPECIAL SARE CLORHIDRAT 2-AMINO-2[2-(4-OCTILFENIL)ETIL]PROPAN-1,3 DIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/677/001, RO EU/1/11/677/002, RO EU/1/11/677/003, RO EU/1/11/677/004; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/677/001, EMEA EU/1/11/677/002, EMEA EU/1/11/677/003, EMEA EU/1/11/677/004; DATE OF FIRST AUTHORISATION IN EEA: 20110317
0443983	C00443983/03	Switzerland	Start Trial	PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
>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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