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PF PRISM CV Company Profile

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

PF PRISM CV has fifteen approved drugs.

There are forty-two US patents protecting PF PRISM CV drugs.

There are one thousand and fourteen patent family members on PF PRISM CV drugs in seventy-seven countries and eighty supplementary protection certificates in fifteen countries.

Summary for PF PRISM CV

International Patents:	1014
US Patents:	42
Tradenames:	11
Ingredients:	11
NDAs:	15

Drugs and US Patents for PF PRISM CV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	CHANTIX	varenicline tartrate	TABLET;ORAL	021928-001	May 10, 2006		RX	Yes	No
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No	8,785,632			Y
Pf Prism Cv	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010		RX	Yes	Yes
Pf Prism Cv	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010		RX	Yes	Yes	6,197,819		Y	Y

Expired US Patents for PF PRISM CV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	VFEND	voriconazole	INJECTABLE;IV (INFUSION)	021267-001	May 24, 2002	5,116,844
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-002	May 24, 2002	5,116,844
Pf Prism Cv	VFEND	voriconazole	INJECTABLE;IV (INFUSION)	021267-001	May 24, 2002	5,364,938
Pf Prism Cv	TYGACIL	tigecycline	POWDER;IV (INFUSION)	021821-001	Jun 15, 2005	5,529,990

Paragraph IV (Patent) Challenges for PF PRISM CV drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg		2008-12-30
	Tablets	50 mg and 200 mg		2008-04-14
	Tablets	1 mg and 2 mg		2009-12-17
	Oral Solution	20 mg/mL		2010-05-19
	Oral Suspension	40 mg/mL		2010-10-08
	Tablets	100mg and 500mg		2016-09-06
	Tablets	1 mg and 5 mg		2018-02-23
	For Injection	200 mg/vial		2008-09-12
	For Injection	50 mg per vial		2009-06-15
	Tablets	0.5 mg and 1 mg		2010-05-10
	Tablets	0.5 mg		2010-08-25
	Injection	25 mg/mL, 1.8 mL vial		2011-05-25
	Tablets	5 mg		2016-11-07

Non-Orange Book US Patents for PF PRISM CV

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
5,684,189	GABA and L-glutamic acid analogs for antiseizure treatment
7,205,300	Aryl fused azapolycyclic compounds
7,144,882	Aryl fused azapolycyclic compounds
6,531,491	Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use

International Patents for PF PRISM CV Drugs

Country	Document Number	Estimated Expiration
South Korea	900006218
Taiwan	I310384
Slovenia	1553940
Croatia	P20050714

Supplementary Protection Certificates for PF PRISM CV Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0130007 00075	Estonia		PRODUCT NAME: KRISOTINIIB;REG NO/DATE: K(2012)7617 LOPLIK 23.10.2012
C0015	France		PRODUCT NAME: CRIZOTINIB ET SES SELS, HYDRATES ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/793/001 20121023
C/GB02/031	United Kingdom		PRODUCT NAME: VORICONAZOLE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/02/212/001-025 20020319
155	Luxembourg		PRODUCT NAME: CRIZOTINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE

Similar Applicant Names

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

• Pf Prism Cv