METVIXIA Drug Patent Profile

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

Metvixia is a drug marketed by Galderma Labs Lp and is included in one NDA.

The generic ingredient in METVIXIA is methyl aminolevulinate hydrochloride. There are four hundred and ninety-one drug master file entries for this compound. Additional details are available on the methyl aminolevulinate hydrochloride profile page.

Summary for METVIXIA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	4
Patent Applications:	44
Formulation / Manufacturing:	see details
DailyMed Link:	METVIXIA at DailyMed

Recent Clinical Trials for METVIXIA

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

Sponsor	Phase
Institut de Cancérologie de Lorraine	Phase 2
Centre Hospitalier Universitaire de Nīmes	N/A
Galderma R&D	Phase 1

See all METVIXIA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for METVIXIA

L01XD	Sensitizers used in photodynamic/radiation therapy
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for METVIXIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	METVIXIA	methyl aminolevulinate hydrochloride	CREAM;TOPICAL	021415-001	Jul 27, 2004		DISCN	No	No

Expired US Patents for METVIXIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	METVIXIA	methyl aminolevulinate hydrochloride	CREAM;TOPICAL	021415-001	Jul 27, 2004

International Patents for METVIXIA

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

Country	Patent Number	Title	Estimated Expiration
Germany	69613365
Japan	3955093
China	1178521
Hungary	225148	ESTERS OF 5-AMINOLEVULINIC ACID AS PHOTOSENSITIZING AGENTS IN PHOTOCHEMOTHERAPY OR DIAGNOSIS, PRODUCTS AND KITS COMPRISING THEREOF AND METHOD OF IN VITRO DIAGNOSIS BY THEIR USING
South Korea	100444007
Czech Republic	9702848
United Kingdom	9504948

Supplementary Protection Certificates for METVIXIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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.
0820432	05C0042	France		PRODUCT NAME: HEXYL AMINOLEVULINATE; NAT. REGISTRATION NO/DATE: NL 30979 20050812; FIRST REGISTRATION: SE - 19 227 20040917
0230742	2001C/040	Belgium		PRODUCT NAME: MONOHYDRATE DU CHLORHYDRATE DE N,N-DIMETHYL-1-4-CHLOROPHENYL)CYCLOBUTYL-3-METHYLBUTYLAMINE ET COMPOSITIONS PHARMACEUTIQUES LE CONTENANT; NAT. REGISTRTION NO/DATE: 479 IS 52 F 5 20010425; FIRST REGISTRATION: CH 54770 19990113
1532149	8/2012	Austria		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830
1948158	16C0018	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
2137537	CA 2014 00035	Denmark		PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
0284288	SPC/GB98/002	United Kingdom		PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730