Novartis Company Profile

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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 three US patents protecting NOVARTIS drugs.

There are two thousand seven hundred and forty-eight 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:	2748
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	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007	AB	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Novartis	PERCORTEN	desoxycorticosterone pivalate	INJECTABLE;INJECTION	008822-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	AB	RX	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No	10,869,869*PED	⤷ Try a Trial			Y	⤷ Try a Trial
Novartis	MAYZENT	siponimod	TABLET;ORAL	209884-001	Mar 26, 2019		RX	Yes	No	8,492,441	⤷ Try a Trial				⤷ Try a Trial
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Novartis	MELLARIL	thioridazine hydrochloride	TABLET;ORAL	011808-006	Approved Prior to Jan 1, 1982		DISCN	Yes	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	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	6,596,750	⤷ Try a Trial
Novartis	TRILEPTAL	oxcarbazepine	SUSPENSION;ORAL	021285-001	May 25, 2001	8,119,148*PED	⤷ Try a Trial
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-002	Jun 29, 1994	5,866,581*PED	⤷ Try a Trial
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015	8,580,306	⤷ Try a Trial
Novartis	LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020192-001	Dec 30, 1992	4,755,534*PED	⤷ Try a Trial
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-002	Dec 28, 1983	3,483,221	⤷ Try a Trial
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,435,567	⤷ 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	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	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg	➤ Subscribe	2004-04-21
➤ Subscribe	Tablets	250 mg	➤ Subscribe	2011-03-14
➤ Subscribe	Tablets	125 mg, 250 mg, and 500 mg	➤ Subscribe	2011-10-28
➤ 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	90 mg and 360 mg	➤ Subscribe	2015-10-19
➤ Subscribe	Tablets	100 mg and 400 mg	➤ Subscribe	2007-03-12
➤ Subscribe	Tablets	320 mg/12.5 mg and 320 mg/25 mg	➤ Subscribe	2007-02-07
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2016-04-28
➤ Subscribe	Capsules	20 mg and 40 mg	➤ Subscribe	2008-06-04
➤ 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	40 mg, 80 mg,160 mg	➤ Subscribe	2004-12-28
➤ Subscribe	Tablets	60 mg and 120 mg	➤ Subscribe	2004-12-22
➤ Subscribe	Extended-release Tablets	100 mg	➤ Subscribe	2005-12-30
➤ Subscribe	Oral Solution	2 mg/mL	➤ Subscribe	2004-11-05
➤ Subscribe	Tablets	0.25 mg, 0.5 mg, and 0.75 mg	➤ Subscribe	2013-09-30
➤ Subscribe	Tablets	10 mg	➤ Subscribe	2014-06-18
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2006-03-02
➤ Subscribe	Capsules	0.5 mg	➤ Subscribe	2014-09-22
➤ Subscribe	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg	➤ Subscribe	2005-12-02
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2015-10-23
➤ Subscribe	Capsules	400 mg	➤ Subscribe	2014-01-24
➤ Subscribe	Tablets	5 mg/160 mg	➤ Subscribe	2007-10-22
➤ Subscribe	Capsules	150 mg and 200 mg	➤ Subscribe	2013-01-29

International Patents for Novartis Drugs

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Country	Patent Number	Estimated Expiration
Mexico	2009011881	⤷ Try a Trial
China	104306350	⤷ Try a Trial
Singapore	189229	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2005025551	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2004094595	⤷ Try a Trial
Austria	397445	⤷ Try a Trial
Honduras	2011000699	⤷ 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
0564409	02C0012	France	⤷ Try a Trial	PRODUCT NAME: IMATINIB MESILATE; NAT. REGISTRATION NO/DATE: EU/1/01/198/001 20011107; FIRST REGISTRATION: LI - IKS 55 807 20010621
0771217	CA 2006 00038	Denmark	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1915993	132013902215595	Italy	⤷ Try a Trial	PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E AMLODIPINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILAMLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/686/001-056, 20110414
0443983	97C0039	Belgium	⤷ Try a Trial	PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513
2435025	CR 2019 00032	Denmark	⤷ Try a Trial	PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER SOLVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
0275821	SPC/GB01/039	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ZOLEDRONIC ACID OPTIONALLY IN THE FORM OF A SALT THEREOF; NATIONAL REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: CH 55463 20001128
2861579	301201	Netherlands	⤷ Try a Trial	PRODUCT NAME: ASCIMINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS ASCIMINIBHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1670 20220826
>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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