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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Deloitte
QuintilesIMS
Boehringer Ingelheim
Daiichi Sankyo
Medtronic
Chinese Patent Office
Fuji
Express Scripts
Merck

Generated: August 18, 2017

DrugPatentWatch Database Preview

Valeant Company Profile

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What is the competitive landscape for VALEANT, and when can generic versions of VALEANT drugs launch?

VALEANT has one hundred and twenty-five approved drugs.

There are forty-seven US patents protecting VALEANT drugs.

There are eight hundred and two patent family members on VALEANT drugs in fifty-five countries.

Summary for Applicant: Valeant

Patents:47
Tradenames:102
Ingredients:80
NDAs:125
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharm Intl
FLUOXYMESTERONE
fluoxymesterone
TABLET;ORAL088221-001May 5, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe
Valeant Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-002Nov 5, 1982ABRXYesNo► Subscribe► Subscribe► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-003Feb 6, 2003ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-002Apr 23, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Pharms Intl
GIAZO
balsalazide disodium
TABLET;ORAL022205-001Feb 3, 2012ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Valeant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-003Dec 27, 1991► Subscribe► Subscribe
Valeant Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-004Dec 8, 1986► Subscribe► Subscribe
Valeant Luxembourg
VISUDYNE
verteporfin
INJECTABLE;INJECTION021119-001Apr 12, 2000► Subscribe► Subscribe
Valeant Pharms
MAXAIR
pirbuterol acetate
AEROSOL, METERED;INHALATION019009-001Dec 30, 1986► Subscribe► Subscribe
Valeant Intl
VASERETIC
enalapril maleate; hydrochlorothiazide
TABLET;ORAL019221-001Oct 31, 1986► Subscribe► Subscribe
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Paragraph IV activity for VALEANT 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 VALEANT

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book Patents for Valeant

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
5,723,594 High affinity PDGF nucleic acid ligands► Subscribe
5,629,155 High-affinity oligonucleotide ligands to immunoglobulin E (IgE)► Subscribe
5,879,716 Methods and compositions for topical delivery of benzoyl peroxide► Subscribe
6,110,900 Nucleic acid ligands► Subscribe
7,005,260Tenascin-C nucleic acid ligands► 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 Valeant Drugs

Country Document Number Estimated Expiration
Germany69942485► Subscribe
Germany69735292► Subscribe
European Patent Office1685842► Subscribe
Germany19732903► Subscribe
ItalyMI991317► 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 Valeant Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369/01Switzerland► SubscribePRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
/2001Austria► SubscribePRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
C/GB02/033United Kingdom► SubscribePRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
C/GB05/029United Kingdom► SubscribePRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
1304992/01Switzerland► SubscribePRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
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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:

Harvard Business School
QuintilesIMS
Merck
Teva
Deloitte
Federal Trade Commission
AstraZeneca
Julphar
Boehringer Ingelheim
Mallinckrodt

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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