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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	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001	AB	RX	Yes	Yes
Hoffmann La Roche	ROMAZICON	flumazenil	INJECTABLE;INJECTION	020073-001	Dec 20, 1991		DISCN	Yes	No
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	7,504,509		Y	Y

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	018662-004	Mar 28, 1983	4,335,125
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-001	May 16, 2003	4,927,814
Hoffmann La Roche	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998	4,966,891
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-002	May 7, 1982	4,200,647

Paragraph IV (Patent) Challenges for HOFFMANN LA ROCHE drugs

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

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
6,627,221	Pharmaceutical composition containing diphosphonic acid or salt thereof
9,663,517	Compositions and uses thereof
7,846,941	Compounds modulating c-kit and c-fms activity and uses therefor
8,329,724	Process for the manufacture of pharmaceutically active compounds

International Patents for Hoffmann La Roche Drugs

Country	Document Number	Estimated Expiration
China	1646193
Australia	2015238857
Croatia	P20151156
Brazil	9915444

Supplementary Protection Certificates for Hoffmann La Roche Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
02/028	Ireland		PRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013
2012010,C1893612	Lithuania		PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
01C/021	Belgium		PRODUCT NAME: CAPECITABINE, NATL REGISTRATION NO/DATE: EU/1/00/163/001 20010205; FIRST REGISTRATION: CH 54657 19980610
C0003	France		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

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