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Serving 500+ biopharmaceutical companies globally:

Fuji
Fish and Richardson
Deloitte
Teva
Chubb
QuintilesIMS
Federal Trade Commission
Daiichi Sankyo
McKesson
Queensland Health

Generated: September 25, 2017

DrugPatentWatch Database Preview

Valeant Intl Company Profile

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

VALEANT INTL has thirteen approved drugs.

There are four US patents protecting VALEANT INTL drugs.

There are thirty-nine patent family members on VALEANT INTL drugs in thirteen countries.

Summary for Applicant: Valeant Intl

Patents:4
Tradenames:11
Ingredients:7
NDAs:13
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-MICRO
tretinoin
GEL;TOPICAL020475-003Jan 28, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Intl
RETIN-A
tretinoin
GEL;TOPICAL017579-002Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Valeant Intl
VASERETIC
enalapril maleate; hydrochlorothiazide
TABLET;ORAL019221-003Jul 12, 1995ABRXYesNo► Subscribe► Subscribe► Subscribe
Valeant Intl
ATIVAN
lorazepam
TABLET;ORAL017794-002Approved Prior to Jan 1, 1982ABRXYesNo► Subscribe► Subscribe► Subscribe
Valeant Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-004Dec 8, 1986ABRXYesYes► Subscribe► Subscribe► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-004Feb 6, 2003ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-001Feb 6, 2003ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-003Feb 6, 2003ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-002Feb 6, 2003ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-006Feb 6, 2003ABRXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Valeant Intl

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-004Feb 6, 2003► Subscribe► Subscribe
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-002May 10, 2002► Subscribe► Subscribe
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-001Feb 7, 1997► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-004Dec 27, 1991► Subscribe► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-006Feb 6, 2003► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-002Dec 27, 1991► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-001Aug 10, 1992► Subscribe► Subscribe
Valeant Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-001Nov 5, 1982► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-003Dec 27, 1991► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-002Dec 27, 1991► Subscribe► Subscribe
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Paragraph IV activity for VALEANT INTL drugs

Drugname Dosage Strength Tradename Submissiondate
tretinoin
Gel0.04%
RETIN-A MICRO
12/20/2010
tretinoin
Gel0.1%
RETIN-A MICRO
7/8/2010
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

Non-Orange Book Patents for Valeant Intl

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
5,145,675 Two step method for preparation of controlled release formulations► Subscribe
6,143,327 Delayed release coated tablet of bupropion hydrochloride► Subscribe
5,879,716 Methods and compositions for topical delivery of benzoyl peroxide► 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 Intl Drugs

Country Document Number Estimated Expiration
South Africa8806284► Subscribe
South Africa8906012► Subscribe
Portugal1131057► Subscribe
Australia613398► Subscribe
Denmark1131057► Subscribe
Austria293438► Subscribe
Canada2307547► Subscribe
Germany60019550► Subscribe
United Kingdom9921933► Subscribe
European Patent Office0277211► 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 Intl Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2001Austria► SubscribePRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
1304992/01Switzerland► SubscribePRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
2013025Lithuania► SubscribePRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
C0038France► SubscribePRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
2008000041Germany► SubscribePRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
2013 00053Denmark► SubscribePRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1458369/01Switzerland► SubscribePRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
13/044Ireland► SubscribePRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
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
01/009Ireland► SubscribePRODUCT NAME: PANRETIN-ALITRETINOIN
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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:

Queensland Health
Harvard Business School
Cerilliant
Accenture
Fish and Richardson
QuintilesIMS
Baxter
Farmers Insurance
Colorcon
Boehringer Ingelheim

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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ISSN: 2162-2639

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