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Serving leading biopharmaceutical companies globally:

Baxter
Cantor Fitzgerald
Colorcon
Boehringer Ingelheim
Chinese Patent Office
Merck
Cipla
Fuji
Cerilliant
McKesson

Generated: October 23, 2017

DrugPatentWatch Database Preview

Vale Company Profile

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

VALE has one hundred and twenty-eight approved drugs.

There are forty-seven US patents protecting VALE drugs.

There are eight hundred and two patent family members on VALE drugs in fifty-five countries and sixty-four supplementary protection certificates in twelve countries.

Summary for Applicant: Vale

International Patents:802
US Patents:47
Tradenames:103
Ingredients:80
NDAs:128
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
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Intl
WELLBUTRIN XL
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL021515-001Aug 28, 2003AB3RXYesNo► Subscribe► Subscribe ► Subscribe
Valeant Pharms North
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL075116-004Dec 23, 1999AB3RXNoNo► Subscribe► Subscribe► Subscribe
Valeant Pharm Intl
TRISORALEN
trioxsalen
TABLET;ORAL012697-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Valeant Pharms Intl
UCERIS
budesonide
TABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Pharm Intl
MESTINON
pyridostigmine bromide
INJECTABLE;INJECTION009830-001Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe
Valeant Pharms Intl
UCERIS
budesonide
TABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Bermuda
XERESE
acyclovir; hydrocortisone
CREAM;TOPICAL022436-001Jul 31, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant
PHRENILIN WITH CAFFEINE AND CODEINE
acetaminophen; butalbital; caffeine; codeine phosphate
CAPSULE;ORAL074911-001Aug 22, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Vale

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Bermuda
RETIN-A
tretinoin
CREAM;TOPICAL019049-001Sep 16, 1988► Subscribe► Subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
CAPSULE;ORAL021055-001Dec 29, 1999► Subscribe► Subscribe
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004► Subscribe► Subscribe
Valeant Pharms North
VASOTEC
enalapril maleate
TABLET;ORAL018998-002Dec 24, 1985► Subscribe► Subscribe
Valeant Pharm Intl
PERMAX
pergolide mesylate
TABLET;ORAL019385-002Dec 30, 1988► Subscribe► Subscribe
Valeant Pharms Llc
TIMOPTIC-XE
timolol maleate
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC020330-002Nov 4, 1993► Subscribe► Subscribe
Valeant Luxembourg
TARGRETIN
bexarotene
GEL;TOPICAL021056-001Jun 28, 2000► Subscribe► Subscribe
Valeant Pharm Intl
PERMAX
pergolide mesylate
TABLET;ORAL019385-003Dec 30, 1988► Subscribe► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-005Feb 6, 2003► Subscribe► Subscribe
Valeant Pharms North
DIASTAT
diazepam
GEL;RECTAL020648-005Jul 29, 1997► Subscribe► Subscribe
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Paragraph IV activity for VALE drugs

Drugname Dosage Strength Tradename Submissiondate
ribavirin
For Inhalation Solution6 gm/vial
VIRAZOLE
5/22/2014
balsalazide disodium
Tablets1.1 g
GIAZO
11/5/2013
budesonide
Extended-release Tablets9 mg
UCERIS
3/11/2013
mesalamine
Extended-release Capsules0.375 g
APRISO
4/3/2012
fluorouracil
Cream0.5%
CARAC
7/29/2011
bexarotene
Capsules75 mg
TARGRETIN
6/6/2011
tretinoin
Gel0.04%
RETIN-A MICRO
12/20/2010
tretinoin
Gel0.1%
RETIN-A MICRO
7/8/2010
bupropion hydrobromide
Extended-release Tablets522 mg
APLENZIN
12/24/2009
bupropion hydrobromide
Extended-release Tablets174 mg
APLENZIN
9/28/2009
bupropion hydrobromide
Extended-release Tablets348 mg
APLENZIN
9/24/2009
diazepam
Rectal Gel5 mg/mL, 2mL pre-filled syringe
DIASTAT ACUDIAL
12/23/2008
diazepam
Rectal Gel5 mg/mL, 4mL pre-filled syringe
DIASTAT ACUDIAL
12/8/2008
tramadol hydrochloride
Extended-release Tablets300 mg
ULTRAM ER
9/25/2007
tramadol hydrochloride
Extended-release Tablets200 mg
ULTRAM ER
3/28/2007
tramadol hydrochloride
Extended-release Tablets100 mg
ULTRAM ER
1/8/2007
diltiazem hydrochloride
Extended-release Tablets120 mg, 180 mg, 240 mg, 300 mg and 360 mg
CARDIZEM LA
8/30/2005
diltiazem hydrochloride
Extended-release Tablets420 mg
CARDIZEM LA
4/25/2005
bupropion hydrochloride
Extended-release Tablets150 mg and 300 mg
WELLBUTRIN XL
9/21/2004
diazepam
Rectal Gel2.5 mg/0.5 mL, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL and 20 mg/4 mL
DIASTAT
3/23/2004

Premature patent expirations for VALE

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book Patents for Vale

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
5,543,293 DNA ligands of thrombin► Subscribe
6,207,816 High affinity oligonucleotide ligands to growth factors► Subscribe
6,479,463 Purine L-nucleosides, analogs and uses thereof► Subscribe
6,716,580 Method for the automated generation of nucleic acid ligands► Subscribe
6,063,772 Specific modulation of Th1/Th2 cytokine expression by ribavirin in activated T-lymphocytes► Subscribe
6,376,474 Systematic evolution of ligands by exponential enrichment: tissue SELEX► Subscribe
6,762,290 High affinity vascular endothelial growth factor (VEGF) receptor nucleic acid ligands and inhibitors► Subscribe
5,958,691 High affinity nucleic acid ligands containing modified nucleotides► Subscribe
9,592,203Controlled release and taste masking oral pharmaceutical composition► Subscribe
6,261,774 Truncation selex method► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Vale Drugs

Country Document Number Estimated Expiration
Spain2241637► Subscribe
Australia5883996► Subscribe
European Patent Office1115887► Subscribe
World Intellectual Property Organization (WIPO)9830223► Subscribe
Australia6225894► Subscribe
Poland336579► Subscribe
European Patent Office1277759► Subscribe
European Patent Office1198589► Subscribe
Spain2310695► Subscribe
Germany69637828► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Vale Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/044Ireland► SubscribePRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
C0021Belgium► SubscribePRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
2010 00009Denmark► Subscribe
C024/2006Ireland► SubscribeSPC024/2006:, EXPIRES: 20210130
252Luxembourg► Subscribe91252, EXPIRES: 20210131
C/GB11/054United Kingdom► SubscribePRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
/1999Austria► SubscribePRODUCT NAME: DORZOLAMID ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE DORZOLAMIDHYDROCHLORID, UND TIMOLOL ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE TIMOLOLMALEAT; NAT. REGISTRATION NO/DATE: 1-22701, 1-22702 19980828; FIRST REGISTRATION: DK 9794 19980306
401Luxembourg► SubscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
172Luxembourg► SubscribePRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
C/GB01/041United Kingdom► SubscribeSUPPLEMENTARY 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.
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Covington
US Army
Dow
McKinsey
Julphar
Daiichi Sankyo
Accenture
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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