Hoffmann La Roche Company Profile

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HOFFMANN LA ROCHE has ten approved drugs.

There are six US patents protecting HOFFMANN LA ROCHE drugs.

There are one hundred and eighty patent family members on HOFFMANN LA ROCHE drugs in forty-six countries and twenty-three supplementary protection certificates in seventeen 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	ROCEPHIN	ceftriaxone sodium	INJECTABLE;INJECTION	062654-001	Apr 30, 1987		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes	7,863,288	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Hoffmann La Roche	ROCEPHIN	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	050585-002	Dec 21, 1984		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes	8,741,920	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>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	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-002	May 7, 1982	4,464,394*PED	⤷ Try a Trial
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983	4,200,647	⤷ Try a Trial
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-001	May 16, 2003	6,294,196	⤷ Try a Trial
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983	4,322,438	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	2.5 mg and 150 mg	➤ Subscribe	2007-05-16
➤ Subscribe	Injection	1 mg/mL, 3 mL Vial	➤ Subscribe	2007-08-31

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Country	Patent Number	Estimated Expiration
Poland	2414356	⤷ Try a Trial
Malaysia	160737	⤷ Try a Trial
Spain	2371397	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007002433	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893612	122, 5012-2012	Slovakia	⤷ Try a Trial	PRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217
1893612	C 2012 020	Romania	⤷ Try a Trial	PRODUCT NAME: VEMURAFENIB SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1212; DATE OF NATIONAL AUTHORISATION: 20120217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1212; DATE OF FIRST AUTHORISATION IN EEA: 20120217
1893612	132012902073472	Italy	⤷ Try a Trial	PRODUCT NAME: VEMURAFENIB(ZELBORAF); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/751/001, 20120221
0432695	32/1996	Austria	⤷ Try a Trial	PRODUCT NAME: SAQUINAVIR UND SEINE SAEUREADDITIONSSALZE, INSBESONDERE SAQUINAVIRMESYLAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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