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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Cantor Fitzgerald
Fuji
Chinese Patent Office
Dow
Julphar
Merck
Baxter
Citi
Covington

Generated: December 16, 2017

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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 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 NorthTIAZACdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020401-004Sep 11, 1995AB4RXYesNo► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthTIAZACdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020401-005Sep 11, 1995AB4RXYesNo► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthTIAZACdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020401-003Sep 11, 1995AB4RXYesNo► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-003Apr 23, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms NorthTIAZACdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020401-002Sep 11, 1995AB4RXYesNo► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthAPLENZINbupropion hydrobromideTABLET, EXTENDED RELEASE;ORAL022108-001Apr 23, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Valeant Pharms NorthTIAZACdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020401-006Oct 16, 1998AB4RXYesYes► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthTIAZACdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020401-001Sep 11, 1995AB4RXYesNo► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthISORDILisosorbide dinitrateTABLET;ORAL012093-007Jul 29, 1988ABRXYesNo► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthDIASTAT ACUDIALdiazepamGEL;RECTAL020648-007Sep 15, 2005RXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Valeant Pharms North

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms NorthDIASTATdiazepamGEL;RECTAL020648-004Jul 29, 1997► Subscribe► Subscribe
Valeant Pharms NorthDIASTATdiazepamGEL;RECTAL020648-002Jul 29, 1997► Subscribe► Subscribe
Valeant Pharms NorthCARACfluorouracilCREAM;TOPICAL020985-001Oct 27, 2000► Subscribe► Subscribe
Valeant Pharms NorthDIASTAT ACUDIALdiazepamGEL;RECTAL020648-007Sep 15, 2005► Subscribe► Subscribe
Valeant Pharms NorthRETIN-AtretinoinCREAM;TOPICAL017340-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Valeant Pharms NorthVASOTECenalapril maleateTABLET;ORAL018998-003Dec 24, 1985► Subscribe► Subscribe
Valeant Pharms NorthRENOVAtretinoinCREAM;TOPICAL019963-001Dec 29, 1995► Subscribe► Subscribe
Valeant Pharms NorthTIAZACdiltiazem hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL020401-001Sep 11, 1995► Subscribe► Subscribe
Valeant Pharms NorthIPRIVASKdesirudin recombinantINJECTABLE;SUBCUTANEOUS021271-001Apr 4, 2003► Subscribe► Subscribe
Valeant Pharms NorthIPRIVASKdesirudin recombinantINJECTABLE;SUBCUTANEOUS021271-001Apr 4, 2003► Subscribe► Subscribe
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Paragraph IV activity for VALEANT PHARMS NORTH drugs

Drugname Dosage Strength Tradename Submissiondate
fluorouracilCream0.5%CARAC7/29/2011
bupropion hydrobromideExtended-release Tablets522 mgAPLENZIN12/24/2009
bupropion hydrobromideExtended-release Tablets174 mgAPLENZIN9/28/2009
bupropion hydrobromideExtended-release Tablets348 mgAPLENZIN9/24/2009
diazepamRectal Gel5 mg/mL, 2mL pre-filled syringeDIASTAT ACUDIAL12/23/2008
diazepamRectal Gel5 mg/mL, 4mL pre-filled syringeDIASTAT ACUDIAL12/8/2008
diazepamRectal Gel2.5 mg/0.5 mL, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL and 20 mg/4 mLDIASTAT3/23/2004

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
8,354,453Bupropion hydrobromide and therapeutic applications► 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
7,884,136Modified-release formulations of a bupropion salt► Subscribe
7,579,380Modified release formulations of a bupropion salt► Subscribe
7,645,901Modified release formulations of a bupropion salt► Subscribe
7,569,611Modified release formulations of a bupropion salt► Subscribe
7,563,823Modified release formulations of a bupropion salt► 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
Canada2655596► Subscribe
Canada2578626► Subscribe
South Korea20080026098► Subscribe
Canada2699588► Subscribe
European Patent Office2474308► Subscribe
World Intellectual Property Organization (WIPO)2009056550► Subscribe
Israel228989► Subscribe
Japan2010535740► Subscribe
Canada2700733► Subscribe
Russian Federation2010116863► 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
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
90049-3Sweden► SubscribePRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
00617Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
00043Netherlands► SubscribePRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
401Luxembourg► SubscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
C/GB01/014United Kingdom► SubscribePRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
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
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
C0114Belgium► SubscribePRODUCT NAME: DESIRUDIN; REGISTRATION NO/DATE: EU/1/97/043/001 19970709
/2001Austria► SubscribePRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
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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:

Express Scripts
Covington
Cerilliant
Boehringer Ingelheim
UBS
Teva
McKinsey
Citi
Argus Health
Merck

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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