Hoffmann La Roche Company Profile

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 eleven US patents protecting HOFFMANN LA ROCHE drugs.

There are two hundred and seventy-seven patent family members on HOFFMANN LA ROCHE drugs in forty-nine countries and thirty supplementary protection certificates in seventeen countries.

Summary for Hoffmann La Roche

International Patents:	277
US Patents:	11
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	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	ceftriaxone sodium	INJECTABLE;INJECTION	050624-003	Feb 11, 1987		DISCN	Yes	No
Hoffmann La Roche	INVIRASE	saquinavir mesylate	CAPSULE;ORAL	020628-001	Dec 6, 1995		DISCN	Yes	No
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005		DISCN	Yes	No	7,410,957
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes	7,504,509		Y	Y
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes	9,447,089		Y
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982		DISCN	Yes	No

Expired US Patents for Hoffmann La Roche

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005	6,294,196
Hoffmann La Roche	FORTOVASE	saquinavir	CAPSULE;ORAL	020828-001	Nov 7, 1997	6,008,228*PED
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982	4,464,394*PED
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-002	May 7, 1982	4,200,647
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005	4,927,814
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001	6,083,953*PED
Hoffmann La Roche	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998	5,472,949*PED

Paragraph IV (Patent) Challenges for HOFFMANN LA ROCHE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	For Oral Solution	50 mg/mL		2011-03-21
	Tablets	2.5 mg and 150 mg		2007-05-16
	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

Premature patent expirations for HOFFMANN LA ROCHE

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

International Patents for Hoffmann La Roche Drugs

Country	Patent Number	Estimated Expiration
Mexico	2012001463
European Patent Office	3088400
Norway	20076659
Cyprus	1116233
Poland	1696920
South Korea	20130128488
European Patent Office	2395004

Supplementary Protection Certificates for Hoffmann La Roche Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0694547	SPC/GB02/027	United Kingdom		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
0316704	2001C/021	Belgium		PRODUCT NAME: CAPECITABINE, NATL REGISTRATION NO/DATE: EU/1/00/163/001 20010205; FIRST REGISTRATION: CH 54657 19980610
1893612	132012902073472	Italy		PRODUCT NAME: VEMURAFENIB(ZELBORAF); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/751/001, 20120221
0316704	SPC/GB01/015	United Kingdom		PRODUCT NAME: CAPECITABINE AND HYDRATES AND SOLVATES THEREOF; REGISTERED: CH 54657 19980610; UK EU/1/00/163/001-002 20010202
1893612	2012C/028	Belgium		PRODUCT NAME: VERMURAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, SOUS TOUTES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/751/001 20120221
1893612	C20120016 00059	Estonia		PRODUCT NAME: ZELBORAF - VEMURAFENIIB;REG NO/DATE: C(2012)1180 FINAL 17.02.2012
1893612	28/2012	Austria		PRODUCT NAME: VEMURAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 (MITTEILUNG) 20120221

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