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Serving leading biopharmaceutical companies globally:

Julphar
US Army
Cerilliant
Daiichi Sankyo
Covington
Fuji
Baxter
Chubb
Merck
Express Scripts

Generated: November 19, 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 and twenty-six supplementary protection certificates in twelve countries.

Summary for Valeant Intl

International Patents:39
US 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
HYTONE
hydrocortisone
LOTION;TOPICAL080473-004Nov 30, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Valeant Intl
BENZAMYCIN
benzoyl peroxide; erythromycin
GEL;TOPICAL050557-001Oct 26, 1984ABRXYesYes► Subscribe► Subscribe► Subscribe
Valeant Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-004Dec 8, 1986ABRXYesYes► Subscribe► Subscribe► Subscribe
Valeant Intl
HYTONE
hydrocortisone
CREAM;TOPICAL080472-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Valeant Intl
RETIN-A-MICRO
tretinoin
GEL;TOPICAL020475-003Jan 28, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Intl
HYTONE
hydrocortisone
CREAM;TOPICAL080472-004Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► 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;ORAL021392-005Feb 6, 2003ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-004Dec 27, 1991AB3RXYesNo► Subscribe► Subscribe► Subscribe
Valeant Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-002Nov 5, 1982ABRXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Valeant Intl

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl
RETIN-A
tretinoin
SOLUTION;TOPICAL016921-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-006Feb 6, 2003► Subscribe► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-003Feb 6, 2003► 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
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-003Dec 27, 1991► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-005Aug 24, 1999► Subscribe► Subscribe
Valeant Intl
CARDIZEM CD
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020062-001Aug 10, 1992► Subscribe► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-005Feb 6, 2003► Subscribe► Subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-002Feb 6, 2003► 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
Australia4903700► Subscribe
Japan2909078► Subscribe
Austria430561► Subscribe
European Patent Office0306236► Subscribe
Canada1303991► Subscribe
Spain2325826► Subscribe
European Patent Office1235562► Subscribe
Japan2003516347► Subscribe
JapanH01500756► Subscribe
South Africa8806284► 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
2000 00018Denmark► SubscribePRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
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
C0038France► SubscribePRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
C0042Belgium► SubscribePRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
/2001Austria► SubscribePRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
C/GB05/029United Kingdom► SubscribePRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
C/GB05/030United Kingdom► SubscribePRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
C/GB01/014United Kingdom► SubscribePRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
C/GB10/005United Kingdom► SubscribePRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
90049-3Sweden► SubscribePRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
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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 leading biopharmaceutical companies globally:

Citi
QuintilesIMS
Deloitte
Fuji
Cantor Fitzgerald
Colorcon
Cerilliant
Healthtrust
McKesson
Novartis

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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