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Novartis Pharms Company Profile

What is the competitive landscape for NOVARTIS PHARMS, and what generic alternatives to NOVARTIS PHARMS drugs are available?

NOVARTIS PHARMS has sixty-two approved drugs.

There are one hundred and fifteen US patents protecting NOVARTIS PHARMS drugs.

There are one thousand eight hundred and thirty-two patent family members on NOVARTIS PHARMS drugs in sixty-eight countries and one hundred and seventy-one supplementary protection certificates in fifteen countries.

Summary for Novartis Pharms

International Patents:	1832
US Patents:	115
Tradenames:	54
Ingredients:	44
NDAs:	62

Drugs and US Patents for Novartis Pharms

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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	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		RX	Yes	Yes	7,153,964	➤ Sign Up	Y	Y		➤ Sign Up
Novartis Pharms Corp	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014		RX	Yes	No	7,473,761	➤ Sign Up	Y	Y		➤ Sign Up
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008		RX	Yes	No	6,280,959*PED	➤ Sign Up			Y	➤ Sign Up
Novartis Pharms Corp	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009		RX	Yes	Yes	7,105,530	➤ Sign Up	Y	Y		➤ Sign Up
Novartis Pharms Corp	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017		RX	Yes	No	6,465,504	➤ Sign Up	Y	Y		➤ Sign Up
Novartis Pharms Corp	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-002	May 29, 2013		DISCN	Yes	No		➤ Sign Up				➤ 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 Pharms

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	ZOFRAN	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-001	Jan 4, 1991	5,578,628*PED	➤ Sign Up
Novartis Pharms Corp	TOBRADEX	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050592-001	Aug 18, 1988	5,149,694	➤ Sign Up
Novartis Pharms Corp	ARRANON	nelarabine	INJECTABLE;IV (INFUSION)	021877-001	Oct 28, 2005	5,747,472	➤ Sign Up
Novartis Pharms Corp	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-001	Jan 27, 1999	5,955,488*PED	➤ Sign Up
Novartis Pharms Corp	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014	6,432,948	➤ Sign Up
Novartis Pharms Corp	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014	6,133,260	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Paragraph IV (Patent) Challenges for NOVARTIS PHARMS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Nasal Spray	0.665 mg/ Spray	➤ Subscribe	2009-06-29
➤ Subscribe	Inhalation Solution	300 mg/5 mL	➤ Subscribe	2009-06-29
➤ Subscribe	Otic Suspension	0.3%/0.1%	➤ Subscribe	2012-07-31
➤ Subscribe	Ophthalmic Emulsion	0.05%	➤ Subscribe	2014-05-01
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2015-10-23
➤ Subscribe	Tablets	12.5 mg and 25 mg	➤ Subscribe	2014-02-04
➤ Subscribe	Tablets	250 mg	➤ Subscribe	2011-03-14
➤ Subscribe	Injection	1 mg/mL, 50 mL vials	➤ Subscribe	2011-12-16
➤ Subscribe	Ophthalmic Solution	0.003%	➤ Subscribe	2015-12-30
➤ Subscribe	Ophthalmic Solution	0.20%	➤ Subscribe	2008-09-08
➤ Subscribe	Ophthalmic Solution	0.7%	➤ Subscribe	2015-09-10
➤ Subscribe	Ophthalmic	0.50%	➤ Subscribe	2005-12-22
➤ Subscribe	Ophthalmic Suspension	0.3%	➤ Subscribe	2015-12-21
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2006-03-02
➤ Subscribe	Tablets	90 mg and 360 mg	➤ Subscribe	2015-10-19
➤ Subscribe	Tablets	50 mg and 75 mg	➤ Subscribe	2014-01-07
➤ Subscribe	Tablets	180 mg	➤ Subscribe	2016-04-28
➤ Subscribe	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24
➤ Subscribe	Oral Solution	4 mg/5 mL	➤ Subscribe	2004-12-20
➤ Subscribe	Ophthalmic Solution	10.5%	➤ Subscribe	2012-02-29
➤ Subscribe	Ophthalmic Solution	0.10%	➤ Subscribe	2006-07-17
➤ Subscribe	Ophthalmic Solution	0.00%	➤ Subscribe	2009-02-19

Non-Orange Book US Patents for Novartis Pharms

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
8,188,037	Microparticles comprising somatostatin analogues	➤ Sign Up
7,674,887	Thrombopoietin mimetics	➤ Sign Up
6,838,449	Ophthalmic compositions containing galactomannan polymers and borate	➤ Sign Up
9,499,493	2,4-pyrimidinediamine compounds and their uses	➤ Sign Up
9,399,021	Pharmaceutical composition	➤ Sign Up
7,754,733	Crystalline topotecan hydrochloride product and process for making the same	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Patents for Novartis Pharms Drugs

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Country	Document Number	Estimated Expiration
South Korea	20030060773	➤ Sign Up
China	1762381	➤ Sign Up
Netherlands	300701	➤ Sign Up
Japan	2007197461	➤ Sign Up
Denmark	1117401	➤ Sign Up
Australia	7493801	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for Novartis Pharms Drugs

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015 00068	Denmark	➤ Sign Up	PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK SALT ELLER DERIVAT DERAF; REG. NO/DATE: EU/1/15/1023 20150901
C/GB12/030	United Kingdom	➤ Sign Up	PRODUCT NAME: CYCLO((4R)-4-(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-)), PASIREOTIDE, OR SALTS THEREOF; REGISTERED: UK EU/1/12/753/001-012 20120424
2015034,C2091918	Lithuania	➤ Sign Up	PRODUCT NAME: CERITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/999 20150506
0248	Netherlands	➤ Sign Up	300248, 20170624, EXPIRES: 20210827
2016000037	Germany	➤ Sign Up	PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
C/GB12/058	United Kingdom	➤ Sign Up	PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
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 Pharms

Paragraph IV (Patent) Challenges for NOVARTIS PHARMS drugs

Similar Applicant Names

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