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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-three 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:	43
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	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-001	Sep 4, 2012		RX	Yes	Yes
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012		RX	Yes	No	6,002,008		Y	Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017		RX	Yes	No	7,417,148
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004		RX	Yes	Yes	6,197,819		Y	Y
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004		RX	Yes	No	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	TABLET;ORAL	021266-002	May 24, 2002	5,567,817
Pf Prism Cv	VFEND	voriconazole	TABLET;ORAL	021266-001	May 24, 2002	5,773,443
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010	5,145,684*PED
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-002	Aug 22, 2002	5,308,847*PED
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999	5,403,833*PED
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012	6,002,008

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

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
7,141,587	Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use
6,262,120	GABA and L-glutamic acid analogs for antiseizure treatment
6,414,024	GABA and L-glutamic acid analogs for antiseizure treatment
6,117,906	GABA and L-glutamic acid analogs for antiseizure treatment
6,140,366	GABA and L-glutamic acid analogs for antiseizure treatment
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
Norway	2008018
South Africa	200804374
Norway	20080051
Serbia	20050708
Dominican Republic	P2004000994
Argentina	053827

Supplementary Protection Certificates for PF PRISM CV Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0037	France		PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001-005 20010313; FIRST REGISTRATION: IKS55243 20000926
C0039	France		PRODUCT NAME: VARENICLINE OU L?UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE TARTRATE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/360/001 DU 20060926; REGISTRATION NO/DATE AT EEC: EU/1/06/360/001 DU 20060926
2013003,C1218348	Lithuania		PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
00348	Netherlands		PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
2008000038	Germany		PRODUCT NAME: VARENICLIN GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES UNTER EINSCHLUSS VON TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001-010 20060926
04C/022	Belgium		PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708

Similar Applicant Names

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

• Pf Prism Cv