You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Amantadine hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, Aurobindo Pharma Usa, Chartwell Rx, Cmp Pharma Inc, Elysium, G And W Labs Inc, Genus, 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-one 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
Chartwell Rx AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 074028-001 Jun 28, 1993 AA RX No Yes ⤷  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 Y ⤷  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
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 Y ⤷  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 209410-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for amantadine hydrochloride

Country Patent Number Title Estimated Expiration
Spain 2549581 ⤷  Try a Trial
European Patent Office 3132793 COMPOSITIONS D'AMANTADINE ET PROCÉDÉS D'UTILISATION (AMANTADINE COMPOSITIONS AND METHODS OF USE) ⤷  Try a Trial
Australia 2015202356 Amantadine compositions and methods of use ⤷  Try a Trial
Mexico 2012006320 COMPOSICIONES DE AMANTADINA Y METODOS PARA SU USO. (AMANTADINE COMPOSITIONS AND METHODS OF USE.) ⤷  Try a Trial
Japan 2020531543 アマンタジン組成物、その調製、および使用方法 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.