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Last Updated: July 13, 2020

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Amantadine hydrochloride - Generic Drug Details

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

Amantadine hydrochloride is the generic ingredient in five branded drugs marketed by Adamas Pharma, Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Heritage Pharma, Invagen Pharms, Invatech, Lannett Co Inc, Rubicon, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Solvay, Endo Pharms, Anda Repository, Cmp Pharma Inc, G And W Labs Inc, Hi Tech Pharma, Pharm Assoc, Teva Pharms, Vintage, Wockhardt Bio Ag, Osmotica Pharm, and Jubilant Generics, and is included in thirty-five NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amantadine hydrochloride has thirty-four patent family members in ten countries.

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

Recent Clinical Trials for amantadine hydrochloride

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SponsorPhase
Ever Neuro Pharma GmbHPhase 4
Adamas Pharmaceuticals, Inc.Phase 4
Konkuk University Medical CenterPhase 4

See all amantadine hydrochloride clinical trials

Pharmacology for amantadine hydrochloride
Medical Subject Heading (MeSH) Categories for amantadine hydrochloride
Paragraph IV (Patent) Challenges for AMANTADINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
GOCOVRI CAPSULE, EXTENDED RELEASE;ORAL amantadine hydrochloride 208944 2020-04-30
GOCOVRI CAPSULE, EXTENDED RELEASE;ORAL amantadine hydrochloride 208944 2018-01-16

US Patents and Regulatory Information 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
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-003 Feb 16, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Invagen Pharms AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 207570-001 Sep 30, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Solvay SYMADINE amantadine hydrochloride CAPSULE;ORAL 071000-001 Sep 4, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 077992-001 Dec 12, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for amantadine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-003 Feb 16, 2018   Start Trial   Start Trial
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018   Start Trial   Start Trial
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Medtronic
McKinsey
AstraZeneca
Boehringer Ingelheim

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