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Hoffmann La Roche Company Profile

HOFFMANN LA ROCHE has thirteen approved drugs.

There are thirteen US patents protecting HOFFMANN LA ROCHE drugs.

There are three hundred and forty-three patent family members on HOFFMANN LA ROCHE drugs in fifty-one countries and twenty-six supplementary protection certificates in fifteen countries.

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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
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes	9,447,089	➤ Sign Up	Y			➤ Sign Up
Hoffmann La Roche	ROCEPHIN	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	050585-004	Dec 21, 1984		DISCN	Yes	No		➤ Sign Up				➤ Sign Up
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257-001	Aug 28, 2009	AB	RX	Yes	Yes		➤ Sign Up				➤ Sign Up
Hoffmann La Roche	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998	AB	RX	Yes	No		➤ Sign Up				➤ Sign Up
Hoffmann La Roche	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	ceftriaxone sodium	INJECTABLE;INJECTION	050624-001	Feb 11, 1987		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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257-001	Aug 28, 2009	6,083,953*PED	➤ Sign Up
Hoffmann La Roche	ROMAZICON	flumazenil	INJECTABLE;INJECTION	020073-001	Dec 20, 1991	4,316,839	➤ Sign Up
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-002	May 7, 1982	4,200,647	➤ Sign Up
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983	4,200,647	➤ Sign Up
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982	4,322,438	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	450 mg	➤ Subscribe	2005-12-27
➤ Subscribe	Injection	1 mg/mL, 3 mL Vial	➤ Subscribe	2007-08-31
➤ Subscribe	Tablets	150 mg and 500 mg	➤ Subscribe	2008-11-10
➤ Subscribe	For Oral Solution	50 mg/mL	➤ Subscribe	2011-03-21
➤ Subscribe	Tablets	2.5 mg and 150 mg	➤ Subscribe	2007-05-16

Patent Number	Expiration Date
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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012000043	Germany	➤ Sign Up	PRODUCT NAME: VEMURAFENIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
/1996	Austria	➤ Sign Up	PRODUCT NAME: SAQUINAVIR UND SEINE SAEUREADDITIONSSALZE, INSBESONDERE SAQUINAVIRMESYLAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
C/GB02/027	United Kingdom	➤ Sign Up	PRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425
2012010	Lithuania	➤ Sign Up	PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
C0003	France	➤ Sign Up	PRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

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