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Last Updated: November 2, 2024

AMANTADINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Amantadine Hydrochloride, and when can generic versions of Amantadine Hydrochloride launch?

Amantadine Hydrochloride is a drug marketed by Zydus, 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, Aurobindo Pharma Usa, Chartwell Rx, Cmp Pharma Inc, Elysium, Endo Operations, G And W Labs Inc, Pharm Assoc, Teva Pharms, Xttrium Labs Inc, Adaptis, Athem, Jubilant Generics, and Zhejiang Jutai Pharm. and is included in thirty-six NDAs.

The generic ingredient in AMANTADINE HYDROCHLORIDE is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Amantadine Hydrochloride

A generic version of AMANTADINE HYDROCHLORIDE was approved as amantadine hydrochloride by UPSHER SMITH LABS on August 5th, 1986.

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Drug patent expirations by year for AMANTADINE HYDROCHLORIDE
Recent Clinical Trials for AMANTADINE HYDROCHLORIDE

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

SponsorPhase
Ohio State UniversityPhase 1
Ain Shams UniversityPhase 3
Shahid Beheshti University of Medical SciencesPhase 2

See all AMANTADINE HYDROCHLORIDE clinical trials

Pharmacology for AMANTADINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for AMANTADINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes 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
Jubilant Generics AMANTADINE HYDROCHLORIDE amantadine hydrochloride TABLET;ORAL 210403-001 Feb 7, 2018 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Adaptis AMANTADINE HYDROCHLORIDE amantadine hydrochloride TABLET;ORAL 212407-001 May 27, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma AMANTADINE HYDROCHLORIDE amantadine hydrochloride TABLET;ORAL 209035-001 Jun 9, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic AMANTADINE HYDROCHLORIDE amantadine hydrochloride TABLET;ORAL 214284-001 Oct 15, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 214897-001 Aug 26, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Usa AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 074170-001 Oct 28, 1994 AA RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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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 verification 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.