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Serving 500+ biopharmaceutical companies globally:

UBS
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Queensland Health
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Moodys
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Generated: August 21, 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.

Summary for Applicant: Vale

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 Intl
RETIN-A
tretinoin
GEL;TOPICAL017579-002Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Valeant Pharms North
PEPCID
famotidine
TABLET;ORAL019462-001Oct 15, 1986ABRXYesNo► Subscribe► Subscribe► Subscribe
Valeant Pharms North
PEPCID
famotidine
TABLET;ORAL019462-002Oct 15, 1986ABRXYesYes► Subscribe► Subscribe► Subscribe
Valeant Intl
HYTONE
hydrocortisone
CREAM;TOPICAL080472-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Valeant Pharms Intl
UCERIS
budesonide
TABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Vale

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-004Dec 8, 1986► Subscribe► Subscribe
Valeant Pharms Llc
MACUGEN
pegaptanib sodium
INJECTABLE;INTRAVITREAL021756-001Dec 17, 2004► Subscribe► Subscribe
Valeant Pharms North
VASOTEC
enalapril maleate
TABLET;ORAL018998-003Dec 24, 1985► Subscribe► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-003Feb 6, 2003► Subscribe► Subscribe
Valeant Pharms Llc
TIMOPTIC-XE
timolol maleate
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC020330-001Nov 4, 1993► 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
5,629,155 High-affinity oligonucleotide ligands to immunoglobulin E (IgE)► Subscribe
6,423,695 Cytokine related treatments of disease► Subscribe
5,853,984 Use of nucleic acid ligands in flow cytometry► Subscribe
6,300,074 Systematic evolution of ligands by exponential enrichment: Chemi-SELEX► Subscribe
6,143,327 Delayed release coated tablet of bupropion hydrochloride► 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
Malaysia119365► Subscribe
Denmark0637297► Subscribe
Canada2566590► Subscribe
South Korea20100055402► Subscribe
Canada2320100► 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
01/009Ireland► SubscribePRODUCT NAME: PANRETIN-ALITRETINOIN
2000 00018Denmark► SubscribePRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
C0114Belgium► SubscribePRODUCT NAME: DESIRUDIN; REGISTRATION NO/DATE: EU/1/97/043/001 19970709
13/044Ireland► SubscribePRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
00054Netherlands► SubscribePRODUCT 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
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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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Serving 500+ biopharmaceutical companies globally:

Cipla
Julphar
Teva
Boehringer Ingelheim
Mallinckrodt
Novartis
AstraZeneca
Dow
Fuji
Johnson and Johnson

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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