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Serving leading biopharmaceutical companies globally:

Cerilliant
Deloitte
QuintilesIMS
US Department of Justice
Julphar
Merck
Accenture
Johnson and Johnson
Covington
Novartis

Generated: November 19, 2017

DrugPatentWatch Database Preview

Forest Labs Llc Company Profile

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What is the competitive landscape for FOREST LABS LLC, and what generic alternatives to FOREST LABS LLC drugs are available?

FOREST LABS LLC has ten approved drugs.

There are thirty-five US patents protecting FOREST LABS LLC drugs and there have been seven Paragraph IV challenges on FOREST LABS LLC drugs in the past three years.

There are three hundred and sixty-one patent family members on FOREST LABS LLC drugs in forty-five countries and eighteen supplementary protection certificates in ten countries.

Summary for Forest Labs Llc

International Patents:361
US Patents:35
Tradenames:9
Ingredients:8
NDAs:10
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Llc
SAPHRIS
asenapine maleate
TABLET;SUBLINGUAL022117-001Aug 13, 2009RXYesNo► Subscribe► Subscribe► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-003Jul 18, 2016RXYesNo► Subscribe► Subscribe ► Subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010ABRXYesYes► Subscribe► SubscribeY► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-001Aug 30, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-003Jul 18, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-004Jul 18, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-003Jul 18, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
Forest Labs Llc
VIIBRYD
vilazodone hydrochloride
TABLET;ORAL022567-003Jan 21, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Forest Labs Llc
VIIBRYD
vilazodone hydrochloride
TABLET;ORAL022567-003Jan 21, 2011RXYesNo► Subscribe► Subscribe ► Subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-002Jun 21, 2010ABRXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Forest Labs Llc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc
NAMENDA
memantine hydrochloride
TABLET;ORAL021487-001Oct 16, 2003► Subscribe► Subscribe
Forest Labs Llc
PYLERA
bismuth subcitrate potassium; metronidazole; tetracycline
CAPSULE;ORAL050786-001Sep 28, 2006► Subscribe► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-002Dec 23, 2014► Subscribe► Subscribe
Forest Labs Llc
NAMENDA
memantine hydrochloride
TABLET;ORAL021487-001Oct 16, 2003► Subscribe► Subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-001Jun 21, 2010► Subscribe► Subscribe
Forest Labs Llc
NAMENDA
memantine hydrochloride
SOLUTION;ORAL021627-001Apr 18, 2005► Subscribe► Subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010► Subscribe► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-001Dec 23, 2014► Subscribe► Subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-003Jun 21, 2010► Subscribe► Subscribe
Forest Labs Llc
NAMENDA
memantine hydrochloride
SOLUTION;ORAL021627-001Apr 18, 2005► Subscribe► Subscribe
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Paragraph IV activity for FOREST LABS LLC drugs

Drugname Dosage Strength Tradename Submissiondate
asenapine maleate
Sublingual Tablets2.5 mg
SAPHRIS
7/27/2017
nebivolol hydrochloride and valsartan
Tablets5 mg/80 mg
BYVALSON
6/9/2017
memantine hydrochloride extended-release and donepezil hydrochloride
Capsules7 mg/10 mg
NAMZARIC
9/26/2016
memantine hydrochloride extended-release and donepezil hydrochloride
Capsules21 mg/10 mg
NAMZARIC
9/23/2016
linaclotide
Capsules145 mcg and 290 mcg
LINZESS
8/30/2016
memantine hydrochloride extended-release and donepezil hydrochloride
Capsules14 mg/10 mg and 28 mg/10 mg
NAMZARIC
5/18/2015
vilazodone hydrochloride
Tablets10 mg, 20 mg, and 40 mg
VIIBRYD
1/21/2015
bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride
Capsules140 mg/125 mg/ 125 mg
PYLERA
8/12/2014
memantine hydrochloride
Extended-release Capsules7 mg, 14 mg, 21 mg, and 28 mg
NAMENDA XR
8/16/2013
asenapine maleate
Sublingual Tablets5 mg and 10 mg
SAPHRIS
8/13/2013
memantine hydrochloride
Extended-release Capsules7 mg, 14 mg, 21 mg
NAMENDA XR
6/17/2013
memantine hydrochloride
Extended-release Capsules28 mg
NAMENDA XR
6/12/2013
memantine hydrochloride
Extended-release Capsules7 mg, 14 mg, 21 mg, and 28 mg
NAMENDA XR
6/10/2013
mesalamine
Suppository1000 mg
CANASA
5/24/2013
memantine hydrochloride
Tablets5 mg and 10 mg
NAMENDA
10/16/2007

Non-Orange Book Patents for Forest Labs Llc

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
7,772,188Methods and compositions for the treatment of gastrointestinal disorders► Subscribe
2,012,058,182► Subscribe
7,981,894Polymorphic forms of 1-'4-(5-cyanoindol-3-yl) butyl-4-(2-carbamoylbenzofuran-5-yl)piperazine hydrochloride► Subscribe
8,921,375Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride► Subscribe
7,619,007Method and composition for administering an NMDA receptor antagonist to a subject► Subscribe
7,541,384Mesalamine suppository► Subscribe
9,624,204Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride► Subscribe
2,012,045,508► Subscribe
8,927,552Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl)piperazine hydrochloride► Subscribe
7,910,546Methods and compositions for the treatment of gastrointestinal disorders► 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 Forest Labs Llc Drugs

Country Document Number Estimated Expiration
Japan2014524444► Subscribe
World Intellectual Property Organization (WIPO)2005117858► Subscribe
Mexico2007006120► Subscribe
Russian Federation2403037► Subscribe
Malaysia151087► Subscribe
South Africa200704233► Subscribe
Germany602004028678► Subscribe
Hungary0400236► Subscribe
Hungary229601► Subscribe
South Korea101310037► 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 Forest Labs Llc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013014Lithuania► SubscribePRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
0593Netherlands► SubscribePRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2013000045Germany► SubscribePRODUCT NAME: LINACLOTID UND JEDE THERAPEUTISCH AEQUIVALENTE FORM DAVON, WELCHE DURCH DAS GRUNDPATENT GESCHUETZT IST, EINSCHLIESSLICH DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
6Finland► Subscribe
02C/035Belgium► SubscribePRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
2013 00026Denmark► Subscribe
00594Netherlands► SubscribePRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
90024-6Sweden► SubscribePRODUCT NAME: LINAKLOTID; REG. NO/DATE: EU/1/12/801/001 20121126
2013013Lithuania► SubscribePRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
200Luxembourg► SubscribePRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTEGE PAR LE BREVET DE BASE,Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES
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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:

Merck
Cantor Fitzgerald
Moodys
Julphar
Baxter
Colorcon
Harvard Business School
Chubb
US Department of Justice
Johnson and Johnson

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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