DrugPatentWatch Database Preview

Novartis Company Profile

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-seven 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:	177
Tradenames:	186
Ingredients:	156
NDAs:	222
Drug Master File Entries:	1

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 Pharms Corp	PROMACTA	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015		RX	Yes	Yes		➤ Sign Up				➤ Sign Up
Novartis	VIVELLE-DOT	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020538-009	May 3, 2002	AB1	RX	Yes	No		➤ Sign Up				➤ Sign Up
Novartis	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes	7,442,388	➤ Sign Up	Y			➤ Sign Up
Novartis	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-008	Apr 21, 2011	AB	RX	Yes	No	6,730,325	➤ 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	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	6,258,808	➤ Sign Up
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-001	Jul 28, 1988	3,652,762	➤ Sign Up
Novartis	VIVELLE-DOT	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020538-008	Jan 8, 1999	5,656,286	➤ Sign Up
Novartis	MYFORTIC	mycophenolic acid	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	6,172,107	➤ 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	Injection	4 mg/100 mg, 100 mL vial	➤ Subscribe	2012-01-31
➤ 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	Capsules	2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg	➤ Subscribe	2004-06-09
➤ Subscribe	Ophthalmic Solution	0.003%	➤ Subscribe	2015-12-30
➤ Subscribe	Transdermal System Extended-release	13.3 mg/24 hr	➤ Subscribe	2013-01-22
➤ Subscribe	Extended-release Capsules	10 mg	➤ Subscribe	2007-05-21
➤ Subscribe	Injection	0.8 mg (base) /mL	➤ Subscribe	2008-06-11
➤ Subscribe	Tablets	5 mg/160 mg	➤ Subscribe	2007-10-22
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2016-04-28
➤ Subscribe	Capsules	400 mg	➤ Subscribe	2014-01-24
➤ Subscribe	Ophthalmic	0.50%	➤ Subscribe	2005-12-22
➤ Subscribe	Nasal Spray	0.665 mg/ Spray	➤ Subscribe	2009-06-29
➤ Subscribe	Tablets	10 mg/160 mg	➤ Subscribe	2007-10-01
➤ Subscribe	Tablets	12.5 mg and 25 mg	➤ Subscribe	2014-02-04
➤ Subscribe	Tablets	60 mg and 120 mg	➤ Subscribe	2004-12-22
➤ 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	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24
➤ Subscribe	Capsules	0.5 mg	➤ Subscribe	2014-09-22
➤ Subscribe	Ophthalmic Solution	0.20%	➤ Subscribe	2008-09-08
➤ Subscribe	Extended-release Capsule	30 mg	➤ Subscribe	2010-12-15
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2004-07-27
➤ Subscribe	Capsules	150 mg and 200 mg	➤ Subscribe	2013-01-29
➤ Subscribe	Tablets	150 mg, 300 mg and 600 mg	➤ Subscribe	2006-05-05
➤ Subscribe	Tablets	250 mg	➤ Subscribe	2011-03-14
➤ Subscribe	Extended-release Capsules	15 mg	➤ Subscribe	2007-05-14
➤ Subscribe	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg	➤ Subscribe	2004-04-21
➤ Subscribe	Tablets	2.5 mg, 5 mg, and 7.5 mg	➤ Subscribe	2014-12-10
➤ Subscribe	Extended-release capsules	35 mg	➤ Subscribe	2011-09-29
➤ Subscribe	Tablets	125 mg, 250 mg and 500 mg	➤ Subscribe	2004-12-28
➤ Subscribe	Ophthalmic Solution	0.00%	➤ Subscribe	2009-02-19
➤ Subscribe	Tablets	90 mg and 360 mg	➤ Subscribe	2015-10-19
➤ Subscribe	Tablets	125 mg, 250 mg, and 500 mg	➤ Subscribe	2011-10-28
➤ Subscribe	Extended-release Tablets	80 mg	➤ Subscribe	2007-03-15
➤ Subscribe	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg	➤ Subscribe	2005-12-02
➤ Subscribe	Ophthalmic Suspension	0.3%	➤ Subscribe	2015-12-21
➤ Subscribe	Ophthalmic Solution	10.5%	➤ Subscribe	2012-02-29
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2006-03-02
➤ Subscribe	Injection	0.05 mg/mL, 100 mL vial	➤ Subscribe	2008-08-29
➤ Subscribe	Capsules	5 mg/40 mg and 10 mg/40 mg	➤ Subscribe	2006-11-17
➤ Subscribe	Tablets for Oral Suspension	2 mg, 3 mg and 5 mg	➤ Subscribe	2016-12-30
➤ Subscribe	Tablets	0.25 mg, 0.5 mg, and 0.75 mg	➤ Subscribe	2013-09-30
➤ Subscribe	Extended-release Capsules	20 mg, 30 mg and 40 mg	➤ Subscribe	2006-08-21
➤ Subscribe	Delayed-release Tablets	180 mg	➤ Subscribe	2009-06-04
➤ Subscribe	Tablets	5 mg/320 mg	➤ Subscribe	2007-11-26
➤ Subscribe	Tablets	50 mg and 75 mg	➤ Subscribe	2014-01-07
➤ Subscribe	Delayed-release Tablets	360 mg	➤ Subscribe	2009-02-02
➤ Subscribe	Inhalation Solution	300 mg/5 mL	➤ Subscribe	2009-06-29
➤ Subscribe	Tablets	10 mg/320 mg	➤ Subscribe	2007-11-09
➤ Subscribe	Tablets	10 mg	➤ Subscribe	2014-06-18
➤ Subscribe	Ophthalmic Solution	0.10%	➤ Subscribe	2006-07-17
➤ Subscribe	Tablets	10 mg/12.5 mg/160 mg	➤ Subscribe	2009-10-22
➤ Subscribe	Extended-release Tablets	100 mg	➤ Subscribe	2005-12-30
➤ Subscribe	Ophthalmic Emulsion	0.05%	➤ Subscribe	2014-05-01
➤ Subscribe	Oral Solution	4 mg/5 mL	➤ Subscribe	2004-12-20
➤ Subscribe	Extended-release Capsule	40 mg	➤ Subscribe	2010-12-20
➤ Subscribe	Tablets	5 mg and 10 mg	➤ Subscribe	2004-05-27
➤ Subscribe	Otic Suspension	0.3%/0.1%	➤ Subscribe	2012-07-31
➤ Subscribe	Oral Suspension	300 mg/5 mL	➤ Subscribe	2006-12-26
➤ Subscribe	Extended-release capsules	25 mg	➤ Subscribe	2011-09-30
➤ Subscribe	Extended-release Capsules	5mg, 10mg and 20 mg	➤ Subscribe	2007-03-30
➤ Subscribe	Oral Solution	2 mg/mL	➤ Subscribe	2004-11-05
➤ Subscribe	Ophthalmic Solution	0.7%	➤ Subscribe	2015-09-10
➤ Subscribe	Injection	1 mg/mL, 50 mL vials	➤ Subscribe	2011-12-16
➤ Subscribe	Capsules	20 mg and 40 mg	➤ Subscribe	2008-06-04
➤ Subscribe	Tablets	40 mg, 80 mg,160 mg	➤ Subscribe	2004-12-28
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2015-10-23

Premature patent expirations for NOVARTIS

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date
➤ Sign Up	➤ Sign Up
➤ Sign Up	➤ Sign Up

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.

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Patent No.	Title	Estimated Patent Expiration
8,912,205	Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors	➤ Sign Up
8,642,759	Benzene sulfonamide thiazole and oxazole compounds	➤ Sign Up
6,242,442	Brinzolamide and brimonidine for treating ocular conditions	➤ Sign Up
7,151,106	Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Patents for Novartis Drugs

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Country	Document Number	Estimated Expiration
Mexico	2008001610	➤ Sign Up
South Korea	100884711	➤ Sign Up
Germany	202009019087	➤ Sign Up
Hungary	E031791	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for Novartis Drugs

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
563	Luxembourg	➤ Sign Up	91563, EXPIRES: 20231028
2012 00018	Denmark	➤ Sign Up	PRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705
C/GB10/032	United Kingdom	➤ Sign Up	PRODUCT NAME: PAZOPANIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; REGISTERED: UK EU 1/10/628/001 20100614; UK EU 1/10/628/002 20100614; UK EU 1/10/628/003 20100614; UK EU 1/10/628/004 20100614
0564409/01	Switzerland	➤ Sign Up	PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

Similar Applicant Names

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

Summary for Novartis

Paragraph IV (Patent) Challenges for NOVARTIS drugs

Premature patent expirations for NOVARTIS

Expiration due to failure to pay maintenance fee

Similar Applicant Names

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