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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	8,143,271		Y	Y
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001	AB	RX	Yes	Yes
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005	AB	RX	Yes	Yes	7,718,634
Hoffmann La Roche	ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER	ceftriaxone sodium	INJECTABLE;INJECTION	050624-001	Feb 11, 1987		DISCN	Yes	No
Hoffmann La Roche	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998	AB	RX	Yes	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	4,464,394*PED
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001	6,083,953*PED
Hoffmann La Roche	VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257-001	Aug 28, 2009	6,083,953*PED
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983	4,322,438
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982	4,322,438

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

International Patents for Hoffmann La Roche Drugs

Country	Document Number	Estimated Expiration
Poland	371346
Peru	15782008
Ukraine	108842
World Intellectual Property Organization (WIPO)	03095029
South Africa	200102276

Supplementary Protection Certificates for Hoffmann La Roche Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/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
2	Finland
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
C/GB12/021	United Kingdom		PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221
2012000043	Germany		PRODUCT NAME: VEMURAFENIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; 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