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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Healthtrust
McKesson
Baxter
Express Scripts
Harvard Business School
Merck
Dow
Accenture
Covington

Generated: October 19, 2017

DrugPatentWatch Database Preview

Valeant Pharms North Company Profile

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

VALEANT PHARMS NORTH has twenty-four approved drugs.

There are ten US patents protecting VALEANT PHARMS NORTH drugs.

There are forty-nine patent family members on VALEANT PHARMS NORTH drugs in seventeen countries and eighteen supplementary protection certificates in ten countries.

Summary for Applicant: Valeant Pharms North

International Patents:49
US Patents:10
Tradenames:22
Ingredients:19
NDAs:24
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-002Apr 23, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-002Apr 23, 2008RXYesNo► Subscribe► Subscribe ► Subscribe
Valeant Pharms North
APLENZIN
bupropion hydrobromide
TABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYesYes► Subscribe► Subscribe ► Subscribe
Valeant Pharms North
TIAZAC
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020401-003Sep 11, 1995AB4RXYesNo► Subscribe► Subscribe► Subscribe
Valeant Pharms North
DIASTAT ACUDIAL
diazepam
GEL;RECTAL020648-007Sep 15, 2005RXYesNo► Subscribe► Subscribe► Subscribe
Valeant Pharms North
RENOVA
tretinoin
CREAM;TOPICAL021108-001Aug 31, 2000RXYesYes► Subscribe► Subscribe ► Subscribe
Valeant Pharms North
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL075116-004Dec 23, 1999AB3RXNoNo► Subscribe► Subscribe► Subscribe
Valeant Pharms North
XENAZINE
tetrabenazine
TABLET;ORAL021894-002Aug 15, 2008ABRXYesYes► Subscribe► Subscribe► Subscribe
Valeant Pharms North
NIFEDIPINE
nifedipine
TABLET, EXTENDED RELEASE;ORAL076070-001Aug 16, 2002AB1RXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Valeant Pharms North

Paragraph IV activity for VALEANT PHARMS NORTH drugs

Drugname Dosage Strength Tradename Submissiondate
fluorouracil
Cream0.5%
CARAC
7/29/2011
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
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

Non-Orange Book Patents for Valeant Pharms North

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
7,645,901Modified release formulations of a bupropion salt► Subscribe
7,553,992Modified release formulations of a bupropion salt► Subscribe
8,932,628Modified release formulations of a bupropion salt► Subscribe
9,504,640Modified release formulations of a bupropion salt► Subscribe
7,569,611Modified release formulations of a bupropion salt► Subscribe
7,579,380Modified release formulations of a bupropion salt► Subscribe
7,884,136Modified-release formulations of a bupropion salt► Subscribe
7,563,823Modified release formulations of a bupropion salt► Subscribe
8,354,453Bupropion hydrobromide and therapeutic applications► 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 Pharms North Drugs

Country Document Number Estimated Expiration
EcuadorSP077999► Subscribe
Costa Rica11259► Subscribe
European Patent Office2214650► Subscribe
Australia2008285660► Subscribe
Russian Federation2408368► Subscribe
South Korea20100055402► Subscribe
World Intellectual Property Organization (WIPO)2009056550► Subscribe
Israel185760► Subscribe
Russian Federation2010116863► Subscribe
Mexico2010003872► 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 Pharms North Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992/01Switzerland► SubscribePRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
C0114Belgium► SubscribePRODUCT NAME: DESIRUDIN; REGISTRATION NO/DATE: EU/1/97/043/001 19970709
90049-3Sweden► SubscribePRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
C/GB01/014United Kingdom► SubscribePRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
2013025,C1304992Lithuania► SubscribePRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
2000 00018Denmark► SubscribePRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
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
C/GB98/003United Kingdom► SubscribePRODUCT NAME: DESIRUDIN, OR A SALT THEREOF; REGISTERED: UK EU/1/97/043/001 19970709; UK EU/1/97/043/002 19970709
401Luxembourg► SubscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
/2000Austria► SubscribePRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
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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:

Colorcon
Julphar
Baxter
Cantor Fitzgerald
McKinsey
Accenture
Chubb
Moodys
Medtronic
UBS

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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