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 ten patent family members on NOVARTIS drugs in seventy-four countries and five hundred and thirty-five supplementary protection certificates in nineteen countries.

Summary for Novartis

International Patents:	3910
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	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes	8,168,655	⤷ Sign Up				⤷ Sign Up
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-002	Jul 7, 2015		RX	Yes	No		⤷ Sign Up				⤷ Sign Up
Novartis	HEAVY SOLUTION NUPERCAINE	dibucaine hydrochloride	INJECTABLE;INJECTION	006203-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017		RX	Yes	Yes	8,222,244	⤷ Sign Up				⤷ Sign Up
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015		RX	Yes	Yes	8,101,659*PED	⤷ Sign Up			Y	⤷ Sign Up
>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	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	7,332,481*PED	⤷ Sign Up
Novartis	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	7,671,070*PED	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012	7,452,874*PED	⤷ Sign Up
Novartis	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003	9,149,486	⤷ Sign Up
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	5,665,772*PED	⤷ Sign Up
>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	➤ Subscribe	2014-06-18
➤ 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	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	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	2.5 mg	➤ Subscribe	2006-03-02
➤ 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	Ophthalmic	0.50%	➤ Subscribe	2005-12-22
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2015-10-23
➤ 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	Injection	0.05 mg/mL, 100 mL vial	➤ Subscribe	2008-08-29
➤ Subscribe	Tablets	250 mg	➤ Subscribe	2011-03-14
➤ Subscribe	Tablets	2.5 mg, 5 mg, and 7.5 mg	➤ Subscribe	2014-12-10
➤ Subscribe	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 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	Oral Solution	2 mg/mL	➤ Subscribe	2004-11-05
➤ 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	0.5 mg	➤ Subscribe	2014-09-22
➤ Subscribe	Nasal Spray	0.665 mg/ Spray	➤ Subscribe	2009-06-29
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2016-04-28
➤ 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
➤ 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

International Patents for Novartis Drugs

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Country	Patent Number	Estimated Expiration
Ukraine	82196	⤷ Sign Up
Peru	20190374	⤷ Sign Up
Japan	2004512810	⤷ Sign Up
China	102065694	⤷ Sign Up
Norway	20151656	⤷ Sign Up
>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	C300154	Netherlands	⤷ Sign Up	PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
1507558	122012000031	Germany	⤷ Sign Up	PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 1), AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 2) UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 3); NAT. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: SCHWEIZ 61678 01 - 05 20110705
0584952	99C0004	Belgium	⤷ Sign Up	PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
2305232	C201930070	Spain	⤷ Sign Up	PRODUCT NAME: ALISKIREN HEMIFUMARATO + HIDROCLOROTIAZIDA; NATIONAL AUTHORISATION NUMBER: EU/1/08/491/001-080; DATE OF AUTHORISATION: 20090116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/08/491/001-080; DATE OF FIRST AUTHORISATION IN EEA: 20090116
0350733	2001C/030	Belgium	⤷ Sign Up	PRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Similar Applicant Names

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Here is a list of applicants with similar names.

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