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Tolmar Company Profile

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

TOLMAR has thirty-one approved drugs.

There are ten US patents protecting TOLMAR drugs.

Summary for Tolmar

US Patents:	10
Tradenames:	22
Ingredients:	22
NDAs:	31
Patent Litigation for Tolmar:	See patent lawsuits for Tolmar

Drugs and US Patents for Tolmar

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tolmar	METRONIDAZOLE	metronidazole	GEL;VAGINAL	077264-001	Oct 31, 2006	AB	RX	No	No
Tolmar	DICLOFENAC SODIUM	diclofenac sodium	GEL;TOPICAL	200936-001	Oct 28, 2013	AB	RX	No	No
Tolmar	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	206164-001	May 23, 2018	AB	RX	No	No

Expired US Patents for Tolmar

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tolmar Therap	ELIGARD	leuprolide acetate	INJECTABLE;SUBCUTANEOUS	021731-001	Dec 14, 2004	5,278,201
Tolmar Therap	ELIGARD	leuprolide acetate	INJECTABLE;SUBCUTANEOUS	021731-001	Dec 14, 2004	5,739,176
Tolmar Therap	ELIGARD	leuprolide acetate	INJECTABLE;SUBCUTANEOUS	021379-001	Jul 24, 2002	5,733,950

Non-Orange Book US Patents for Tolmar

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
6,143,314	Controlled release liquid delivery compositions with low initial drug burst
6,630,155	Controlled release liquid delivery compositions with low initial drug burst

International Patents for Tolmar Drugs

Country	Document Number	Estimated Expiration
Austria	285261
European Patent Office	1267965
Brazil	PI0114069

Supplementary Protection Certificates for Tolmar Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB05/030	United Kingdom		PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
C0024	France		PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
C0038	France		PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026

Similar Applicant Names

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

• Tolmar
• Tolmar Therap