Vale Company Profile

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What is the competitive landscape for VALE

VALE has seventy approved drugs.

There are six US patents protecting VALE drugs.

Summary for Vale

US Patents:	6
Tradenames:	56
Ingredients:	45
NDAs:	70
Patent Litigation for Vale:	See patent lawsuits for Vale

Drugs and US Patents for Vale

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms Intl	CUPRIMINE	penicillamine	CAPSULE;ORAL	019853-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Valeant Pharm Intl	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	080596-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Pharm Intl	TRISORALEN	trioxsalen	TABLET;ORAL	012697-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Pharm Intl	LIBRITABS	chlordiazepoxide	TABLET;ORAL	085488-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Pharm Intl	MEPROBAMATE	meprobamate	TABLET;ORAL	015139-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Pharm Intl	FOLIC ACID	folic acid	TABLET;ORAL	080903-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for Vale

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-001	Approved Prior to Jan 1, 1982	4,316,897
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012	7,452,872
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005	6,254,887
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-002	Sep 8, 2005	6,254,887
Valeant Pharm Intl	PERMAX	pergolide mesylate	TABLET;ORAL	019385-002	Dec 30, 1988	5,114,948
Valeant Pharms North	RENOVA	tretinoin	CREAM;TOPICAL	019963-001	Dec 29, 1995	RE36068

Paragraph IV (Patent) Challenges for VALE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	100 mg		2007-01-08
	Extended-release Tablets	300 mg		2007-09-25
	Extended-release Tablets	200 mg		2007-03-28
	Tablets	1.1 g		2013-11-05

International Patents for Vale Drugs

Country	Patent Number	Estimated Expiration
Japan	2013032395
Japan	2012246322
Canada	2816276
Japan	2018145202
Canada	2668441
South Korea	20090118906

Supplementary Protection Certificates for Vale Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1586316	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1539166	2013/055	Ireland		PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624
0186118	SPC/GB05/029	United Kingdom		PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	CR 2013 00053	Denmark		PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322

Similar Applicant Names

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

• Vale
• Valeant
• Valeant Bermuda
• Valeant Intl
• Valeant Luxembourg
• Valeant Pharm Intl