Roche Company Profile

What is the competitive landscape for ROCHE, and what generic and branded alternatives to ROCHE drugs are available?

ROCHE has sixty-one approved drugs.

Summary for Roche

US Patents:	0
Tradenames:	49
Ingredients:	45
NDAs:	61
Patent Litigation for Roche:	See patent lawsuits for Roche

Drugs and US Patents for Roche

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	VALIUM	diazepam	INJECTABLE;INJECTION	016087-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Roche	COACTIN	amdinocillin	INJECTABLE;INJECTION	050565-003	Dec 21, 1984		DISCN	No	No
Roche	TAMIFLU	oseltamivir phosphate	FOR SUSPENSION;ORAL	021246-002	Mar 21, 2011	AB	RX	Yes	Yes
Roche	RIMADYL	carprofen	TABLET;ORAL	018550-002	Dec 31, 1987		DISCN	No	No
Roche	TEGISON	etretinate	CAPSULE;ORAL	019369-002	Sep 30, 1986		DISCN	No	No
Roche Palo	TORADOL	ketorolac tromethamine	INJECTABLE;INJECTION	019698-002	Nov 30, 1989		DISCN	Yes	No
Roche Palo	TICLID	ticlopidine hydrochloride	TABLET;ORAL	019979-002	Oct 31, 1991		DISCN	No	No

Expired US Patents for Roche

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	RIMADYL	carprofen	TABLET;ORAL	018550-002	Dec 31, 1987	3,896,145
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-001	Dec 23, 1997	4,758,598
Roche Palo	TICLID	ticlopidine hydrochloride	TABLET;ORAL	019979-002	Oct 31, 1991	4,051,141
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-004	Dec 23, 1997	4,371,516
Roche	FUZEON	enfuvirtide	INJECTABLE;SUBCUTANEOUS	021481-001	Mar 13, 2003	5,464,933
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-004	Dec 23, 1997	4,758,598
Roche	DEMADEX	torsemide	INJECTABLE;INJECTION	020137-002	Aug 23, 1993	RE30633

Paragraph IV (Patent) Challenges for ROCHE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	1 mg/mL, 4 mL multi-dose vials		2004-07-19
	Tablets	2.5 mg and 150 mg		2007-05-16
	Capsule	75 mg		2010-11-15
	Oral Suspension	6 mg/mL		2015-06-18
	Injection	1 mg/mL, 1 mL vials		2004-06-01
	Injection	1 mg/mL, 3 mL Vial		2007-08-31
	For Oral Suspension	200 mg/mL		2011-03-25
	Capsules	30 mg and 45 mg		2011-08-02
	Injection	0.1 mg/mL, 1 mL single dose vial		2007-03-08

Similar Applicant Names

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

• Roche
• Roche Palo