DrugPatentWatch Database Preview

NOVARTIS Company Profile

« Back to Dashboard

What is the competitive landscape for NOVARTIS, and when can generic versions of NOVARTIS drugs launch?

NOVARTIS has two hundred and twenty-two approved drugs.

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

There are three thousand six hundred and fifty-two patent family members on NOVARTIS drugs in seventy-seven countries and three hundred and sixty-three supplementary protection certificates in fifteen countries.

Summary for NOVARTIS

International Patents:	3652
US Patents:	178
Tradenames:	186
Ingredients:	156
NDAs:	222
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010	AB	RX	Yes	Yes	5,665,772*PED				Y
Novartis	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	CAPSULE;ORAL	074857-001	Sep 9, 1997		DISCN	No	No
Novartis	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012		RX	Yes	Yes	7,473,761		Y	Y

Expired US Patents for NOVARTIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-003	Mar 30, 2015	6,596,750
Novartis	LAMISIL	terbinafine hydrochloride	TABLET;ORAL	020539-001	May 10, 1996	4,755,534*PED
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-005	Apr 28, 2006	6,294,197*PED

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Ophthalmic Emulsion	0.05%		2014-05-01
	Capsules	20 mg and 40 mg		2008-06-04
	Tablets	320 mg/12.5 mg and 320 mg/25 mg		2007-02-07
	Extended-release Capsules	15 mg		2007-05-14
	Tablets	180 mg		2015-10-23
	Tablets	12.5 mg and 25 mg		2014-02-04
	Capsules	5 mg/40 mg and 10 mg/40 mg		2006-11-17
	Tablets	5 mg/320 mg		2007-11-26
	Extended-release Capsule	30 mg		2010-12-15
	Tablets	250 mg		2011-03-14
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	Injection	0.05 mg/mL, 100 mL vial		2008-08-29
	Tablets	10 mg/320 mg		2007-11-09
	Extended-release capsules	25 mg		2011-09-30
	Injection	4 mg/100 mg, 100 mL vial		2012-01-31
	Ophthalmic Solution	0.003%		2015-12-30
	Tablets	10 mg/12.5 mg/160 mg		2009-10-22
	Extended-release Capsules	10 mg		2007-05-21
	Oral Suspension	300 mg/5 mL		2006-12-26
	Ophthalmic Solution	0.20%		2008-09-08
	Tablets	2.5 mg		2004-07-27
	Tablets	40 mg, 80 mg,160 mg		2004-12-28
	Delayed-release Tablets	180 mg		2009-06-04
	Ophthalmic Solution	0.7%		2015-09-10
	Tablets	60 mg and 120 mg		2004-12-22
	Oral Solution	2 mg/mL		2004-11-05
	Extended-release Tablets	100 mg		2005-12-30
	Ophthalmic	0.50%		2005-12-22
	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg		2016-12-30
	Capsules	0.5 mg		2014-09-22
	Tablets	10 mg		2014-06-18
	Ophthalmic Suspension	0.3%		2015-12-21
	Tablets	2.5 mg		2006-03-02
	Capsules	400 mg		2014-01-24
	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg		2005-12-02
	Tablets	90 mg and 360 mg		2015-10-19
	Tablets	50 mg and 75 mg		2014-01-07
	Capsules	2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg		2004-06-09
	Tablets	5 mg/160 mg		2007-10-22
	Extended-release Capsules	5mg, 10mg and 20 mg		2007-03-30
	Tablets	180 mg		2016-04-28
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	Capsules	150 mg and 200 mg		2013-01-29
	Tablets	10 mg/160 mg		2007-10-01
	Extended-release Capsule	40 mg		2010-12-20
	Oral Solution	4 mg/5 mL		2004-12-20
	Injection	0.8 mg (base) /mL		2008-06-11
	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		2009-09-14
	Extended-release capsules	35 mg		2011-09-29
	Tablets	150 mg, 300 mg and 600 mg		2006-05-05
	Ophthalmic Solution	10.5%		2012-02-29
	Tablets	125 mg, 250 mg and 500 mg		2004-12-28
	Extended-release Capsules	20 mg, 30 mg and 40 mg		2006-08-21
	Delayed-release Tablets	360 mg		2009-02-02
	Ophthalmic Solution	0.10%		2006-07-17
	Tablets	5 mg and 10 mg		2004-05-27
	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg		2004-04-21
	Extended-release Tablets	80 mg		2007-03-15
	Ophthalmic Solution	0.00%		2009-02-19
	Tablets	0.25 mg, 0.5 mg, and 0.75 mg		2013-09-30
	Transdermal System Extended-release	13.3 mg/24 hr		2013-01-22
	Tablets	125 mg, 250 mg, and 500 mg		2011-10-28
	Nasal Spray	0.665 mg/ Spray		2009-06-29
	Inhalation Solution	300 mg/5 mL		2009-06-29
	Tablets	100 mg and 400 mg		2007-03-12
	Tablets	2.5 mg, 5 mg, and 7.5 mg		2014-12-10
	Otic Suspension	0.3%/0.1%		2012-07-31

Premature patent expirations for NOVARTIS

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

Non-Orange Book US Patents for NOVARTIS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,565,885	Methods of spray drying pharmaceutical compositions
7,709,012	Ophthalmic compositions containing a synergistic combination of two polymers
6,440,990	O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants

International Patents for NOVARTIS Drugs

Country	Document Number	Estimated Expiration
Iceland	2923
Canada	2413134
China	1650863

Supplementary Protection Certificates for NOVARTIS Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2008	Austria		PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
C0083	France		PRODUCT NAME: TRAMETINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL,HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/14/931 20140630
C/GB97/009	United Kingdom		PRODUCT NAME: VALSARTAN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 36983.00.00 19960513; DE 36983.01.00 19960513; UK 00001/0218 19961016; UK 00001/0219 19961016; UK 00001/0225 19961016

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Nova Labs Ltd
• Novartis
• Novartis Pharm