TARGRETIN Drug Patent Profile

Which patents cover Targretin, and when can generic versions of Targretin launch?

Targretin is a drug marketed by Valeant Luxembourg and Bausch and is included in two NDAs.

The generic ingredient in TARGRETIN is bexarotene. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bexarotene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Targretin

A generic version of TARGRETIN was approved as bexarotene by BIONPHARMA on August 12^th, 2014.

Summary for TARGRETIN

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	30
Patent Applications:	5,189
Drug Prices:	Drug price information for TARGRETIN
What excipients (inactive ingredients) are in TARGRETIN?	TARGRETIN excipients list
DailyMed Link:	TARGRETIN at DailyMed

See drug prices for TARGRETIN

Recent Clinical Trials for TARGRETIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Centre, Singapore	Phase 1
National Medical Research Council (NMRC), Singapore	Phase 1
The Cleveland Clinic	Phase 2

See all TARGRETIN clinical trials

Pharmacology for TARGRETIN

Drug Class

Retinoid

US Patents and Regulatory Information for TARGRETIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Luxembourg	TARGRETIN	bexarotene	CAPSULE;ORAL	021055-001	Dec 29, 1999	AB	RX	Yes	Yes
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000	AB	RX	Yes	Yes

Expired US Patents for TARGRETIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Luxembourg	TARGRETIN	bexarotene	CAPSULE;ORAL	021055-001	Dec 29, 1999
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000
Valeant Luxembourg	TARGRETIN	bexarotene	CAPSULE;ORAL	021055-001	Dec 29, 1999
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056-001	Jun 28, 2000

EU/EMA Drug Approvals for TARGRETIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eisai GmbH	Targretin	bexarotene	EMEA/H/C/000326 Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.	Authorised	no	no	no	2001-03-29

International Patents for TARGRETIN

See the table below for patents covering TARGRETIN around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	678086
Austria	187434
Austria	256653
Germany	69324043
Germany	69329278

Supplementary Protection Certificates for TARGRETIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0637297	SPC013/2001	Ireland		SPC013/2001: 20031205, EXPIRES: 20160328
0637297	CA 2001 00032	Denmark
0637297	01C0027	France		PRODUCT NAME: BEXAROTENE; REGISTRATION NO/DATE: EU/1/01/178/001 20010329
0637297	SPC/GB01/041	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB01/041 GRANTED TO EISAI R + D MANAGEMENT., LTD. IN RESPECT OF THE PRODUCT BEXAROTENE (4-(1-(3, 5, 5, 8, 8-PENTAMETHYL-5, 6, 7, 8-TETRAHYDRO-2-NAPHTHALENYL)VINYL)BENZOIC ACID), WHICH WAS ADVERTISED AS COMING INTO FORCE IN JOURNAL NO 6469 DATED 15/05/2013 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, IT WILL EXPIRE ON 01/04/2016.
0637297	C300054	Netherlands		PRODUCT NAME: BEXAROTENE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVER- BINDING MET DE FORMULE R9OH, WAARIN R9 EEN; NAT. REGISTRATION NO/DATE: EU/1/01/178/001 20010329; FIRST REGISTRATION: EU/1/01/178/001 20010329