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Serving leading biopharmaceutical companies globally:

Healthtrust
Novartis
Medtronic
Covington
Fish and Richardson
Cantor Fitzgerald
US Army
Fuji
Cerilliant
Boehringer Ingelheim

Generated: October 19, 2017

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Amantadine hydrochloride - Generic Drug Details

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What are the generic sources for amantadine hydrochloride and what is the scope of amantadine hydrochloride patent protection?

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-four suppliers are listed for this compound.

Summary for Generic Name: amantadine hydrochloride

US Patents:9
Tradenames:4
Applicants:24
NDAs:30
Drug Master File Entries: see list7
Suppliers / Packagers: see list44
Bulk Api Vendors: see list89
Clinical Trials: see list2,361
Patent Applications: see list2,102
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amantadine hydrochloride at DailyMed

Pharmacology for Ingredient: amantadine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adamas Pharma
GOCOVRI
amantadine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL208944-001Aug 24, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
Adamas Pharma
GOCOVRI
amantadine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL208944-002Aug 24, 2017RXYesYes► Subscribe► SubscribeY ► Subscribe
Adamas Pharma
GOCOVRI
amantadine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL208944-001Aug 24, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Adamas Pharma
GOCOVRI
amantadine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL208944-002Aug 24, 2017RXYesYes► Subscribe► Subscribe ► Subscribe
Watson Labs Inc
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
CAPSULE;ORAL208107-001Dec 6, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
CAPSULE;ORAL071293-001Feb 18, 1987ABRXNoYes► Subscribe► Subscribe► Subscribe
Lannett Holdings Inc
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
CAPSULE;ORAL209221-001Jun 15, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Newgen Pharms Llc
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
CAPSULE;ORAL207570-001Sep 30, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Adamas Pharma
GOCOVRI
amantadine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL208944-002Aug 24, 2017RXYesYes► Subscribe► SubscribeY ► Subscribe
Vintage
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride
SYRUP;ORAL077992-001Dec 12, 2006DISCNNoNo► Subscribe► Subscribe► 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
Japan2017019874► Subscribe
Japan2013512919► Subscribe
European Patent Office2623099► Subscribe
Australia2015202356► Subscribe
Japan5885668► Subscribe
World Intellectual Property Organization (WIPO)2011069010► Subscribe
China102883601► Subscribe
European Patent Office2506709► Subscribe
World Intellectual Property Organization (WIPO)2006058236► Subscribe
European Patent Office1845968► 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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Serving leading biopharmaceutical companies globally:

McKinsey
Citi
Express Scripts
Fish and Richardson
Queensland Health
Colorcon
Harvard Business School
Medtronic
US Army
Cerilliant

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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