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Hoffmann La Roche Company Profile

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What is the competitive landscape for HOFFMANN LA ROCHE, and when can generic versions of HOFFMANN LA ROCHE drugs launch?

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.

Summary for Hoffmann La Roche

International Patents:	343
US Patents:	13
Tradenames:	11
Ingredients:	10
NDAs:	13

Drugs and US Patents for Hoffmann La Roche

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	8,741,920		Y	Y
Hoffmann La Roche	ROCEPHIN	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	050585-002	Dec 21, 1984		DISCN	Yes	No
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes
Hoffmann La Roche	ROCEPHIN	ceftriaxone sodium	INJECTABLE;INJECTION	063239-001	Aug 13, 1993		DISCN	No	No

Expired US Patents for Hoffmann La Roche

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982	4,322,438
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983	4,464,394*PED
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-002	May 7, 1982	4,464,394*PED
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001	6,083,953*PED

Paragraph IV (Patent) Challenges for HOFFMANN LA ROCHE drugs

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

Premature patent expirations for HOFFMANN LA ROCHE

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

Non-Orange Book US Patents for Hoffmann La Roche

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
8,329,724	Process for the manufacture of pharmaceutically active compounds
7,846,941	Compounds modulating c-kit and c-fms activity and uses therefor
8,415,469	Compounds and methods for kinase modulation, and indications therefor
6,627,221	Pharmaceutical composition containing diphosphonic acid or salt thereof

International Patents for Hoffmann La Roche Drugs

Country	Document Number	Estimated Expiration
Brazil	PI0611863
South Korea	101739994
Serbia	52457
Taiwan	I432193

Supplementary Protection Certificates for Hoffmann La Roche Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012010	Lithuania		PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
2, 5012-2012	Slovakia		PRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217
C/GB12/021	United Kingdom		PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221
00534	Netherlands		PRODUCT NAME: VEMURAFENIB ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/751/001 20120217

Similar Applicant Names

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

• Hoffmann La Roche
• Hoffmann-la Roche