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Last Updated: March 4, 2024

Amantadine hydrochloride - Generic Drug Details


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What are the generic 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 Operations, Actavis Elizabeth, Alembic, Bionpharma, Chartwell Molecular, Heritage Pharma, Humanwell Puracap, Invagen Pharms, Rising, Rubicon, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Solvay, Endo Pharms, Anda Repository, Aurobindo Pharma Usa, Chartwell Rx, Cmp Pharma Inc, Elysium, G And W Labs Inc, Pharm Assoc, Teva Pharms, Vintage, Xttrium Labs Inc, Athem, Edenbridge Pharms, and Jubilant Generics, and is included in forty NDAs. There are twenty-eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amantadine hydrochloride has forty-five patent family members in eleven countries.

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

Recent Clinical Trials for amantadine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shahid Beheshti University of Medical SciencesPhase 2
Hospital San Carlos, MadridPhase 3
University Hospital TuebingenPhase 2

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 Strength NDA ANDAs Submitted Submissiondate
GOCOVRI Extended-release Capsules amantadine hydrochloride 68.5 mg 208944 1 2020-04-30
GOCOVRI Extended-release Capsules amantadine hydrochloride 137 mg 208944 1 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 Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Adamas Operations GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-004 Apr 22, 2020 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018 ⤷  Try a Trial ⤷  Try a Trial
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-003 Feb 16, 2018 ⤷  Try a Trial ⤷  Try a Trial
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for amantadine hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 1845968 COMPOSITION ET METHODE POUR TRAITER DES AFFECTIONS NEUROLOGIQUES (COMPOSITION COMPRISING AN NMDA RECEPTOR ANTAGONIST AND LEVODOPA AND USE THEREOF FOR TREATING NEUROLOGICAL DISEASE) ⤷  Try a Trial
European Patent Office 3672581 COMPOSITIONS D'AMANTADINE, LEURS PRÉPARATION, ET PROCÉDÉS D'UTILISATION (AMANTADINE COMPOSITIONS, PREPARATIONS THEREOF, AND METHODS OF USE) ⤷  Try a Trial
Mexico 2007006472 DISPOSITIVO OSMOTICO QUE CONTIENE AMANTADINA Y UNA SAL OSMOTICA. (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT.) ⤷  Try a Trial
Canada 3072764 COMPOSITIONS D'AMANTADINE, LEURS PREPARATION, ET PROCEDES D'UTILISATION (AMANTADINE COMPOSITIONS, PREPARATIONS THEREOF, AND METHODS OF USE) ⤷  Try a Trial
Brazil 112012013487 COMPOSIÇÕES DE AMANTADINA E MÉTODOS DE USO ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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