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Novartis Pharms Company Profile

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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

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	TABLET;ORAL	022291-003	Sep 8, 2009		RX	Yes	Yes	7,332,481*PED				Y
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015		RX	Yes	Yes
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009		RX	Yes	Yes	8,052,993*PED				Y
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015		RX	Yes	Yes	7,547,719*PED				Y

Expired US Patents for Novartis Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-002	Oct 11, 2007	5,004,758*PED
Novartis Pharms Corp	PATANOL	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	4,923,892
Novartis Pharms Corp	ZOFRAN ODT	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	020781-002	Jan 27, 1999	4,695,578*PED
Novartis Pharms Corp	ZOFRAN	ondansetron hydrochloride	TABLET;ORAL	020103-002	Dec 31, 1992	4,753,789*PED

Paragraph IV (Patent) Challenges for NOVARTIS PHARMS drugs

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

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.

Patent No.	Title	Estimated Patent Expiration
6,486,138	Ophthalmic compositions containing galactomannan polymers and borate
7,709,012	Ophthalmic compositions containing a synergistic combination of two polymers
7,858,626	Pyrimidineamines as angiogenesis modulators
7,812,029	Methods of treating or preventing autoimmune diseases with 2,4-pyrimidinediamine compounds

International Patents for Novartis Pharms Drugs

Country	Document Number	Estimated Expiration
Portugal	1871347
South Korea	20130132433
Japan	2013139476
Hungary	0400691

Supplementary Protection Certificates for Novartis Pharms Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014039,C1761528	Lithuania		PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
/2010	Austria		PRODUCT NAME: PAZOPANIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/628/001 - EU/1/10/628/004 20100614
C0058	France		PRODUCT NAME: NELARABINE, OU L?UN DE SES DERIVES PHYSIOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/403/001 DU 20070822; REGISTRATION NO/DATE AT EEC: EU/1/07/403/001 DU 20070822
1	Finland

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
• Novartis Pharms