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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Dow
McKinsey
Chinese Patent Office
Cerilliant
Covington
Argus Health
Daiichi Sankyo
Moodys

Generated: November 22, 2017

DrugPatentWatch Database Preview

AMANTADINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for amantadine hydrochloride and what is the scope of amantadine hydrochloride freedom to operate?

Amantadine hydrochloride
is the generic ingredient in four branded drugs marketed by Solvay, Endo Pharms, Watson Labs Inc, Pharm Assoc, Teva Pharms, Cmp Pharma Inc, Bionpharma Inc, Lannett Holdings Inc, Mikart, Strides Pharma, Adamas Pharma, Silarx, G And W Labs Inc, Actavis Elizabeth, Wockhardt, Alembic Pharms Ltd, Newgen Pharms Llc, Hi Tech Pharma, Heritage Pharma, Zydus Pharms Usa Inc, Watson Labs, Usl Pharma, Vintage, and Sandoz, and is included in thirty NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amantadine hydrochloride has eighteen patent family members in seven countries.

There are seven drug master file entries for amantadine hydrochloride. Forty-three suppliers are listed for this compound.

Pharmacology for AMANTADINE HYDROCHLORIDE

Medical Subject Heading (MeSH) Categories for AMANTADINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms
SYMMETREL
amantadine hydrochloride
SYRUP;ORAL016023-002Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa Inc
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
CAPSULE;ORAL208278-001May 31, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Newgen Pharms Llc
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
TABLET;ORAL207571-001Jan 31, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Lannett Holdings Inc
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
CAPSULE;ORAL209221-001Jun 15, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
CAPSULE;ORAL071293-001Feb 18, 1987ABRXNoYes► Subscribe► Subscribe► Subscribe
Watson Labs
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
CAPSULE;ORAL071382-001Jan 21, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Cmp Pharma Inc
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
SYRUP;ORAL075819-001Sep 11, 2002AARXNoYes► Subscribe► Subscribe► Subscribe
Endo Pharms
SYMMETREL
amantadine hydrochloride
CAPSULE;ORAL016020-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Endo Pharms
SYMMETREL
amantadine hydrochloride
TABLET;ORAL018101-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Adamas Pharma
GOCOVRI
amantadine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL208944-001Aug 24, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: amantadine hydrochloride

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
8,987,333Composition and method for treating neurological disease► Subscribe
9,072,697Composition and method for treating neurological disease► 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 Ingredient: amantadine hydrochloride

Country Document Number Estimated Expiration
Australia2015202356► Subscribe
Australia2010325960► Subscribe
European Patent Office1845968► Subscribe
Japan2015131818► Subscribe
Japan6038203► Subscribe
European Patent Office2623099► Subscribe
Japan5885668► Subscribe
China106389381► Subscribe
World Intellectual Property Organization (WIPO)2006058236► Subscribe
Canada2588296► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Chubb
Cerilliant
US Department of Justice
Dow
QuintilesIMS
Express Scripts
Cantor Fitzgerald
Cipla

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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