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Last Updated: October 24, 2021

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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 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, Lannett Co Inc, Novelgenix Theraps, Rubicon, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Solvay, Endo Pharms, Akorn, Anda Repository, Cmp Pharma Inc, G And W Labs Inc, Invatech, Pharm Assoc, Teva Pharms, Vintage, Wockhardt Bio Ag, and Jubilant Generics, and is included in thirty-seven NDAs. There are twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Recent Clinical Trials for amantadine hydrochloride

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

SponsorPhase
All India Institute of Medical Sciences, BhubaneswarPhase 4
Indian Council of Medical ResearchPhase 4
Copenhagen University Hospital, HvidovrePhase 3

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 OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-004 Apr 22, 2020 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cmp Pharma Inc AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 075819-001 Sep 11, 2002 AA RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zydus Pharms AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 208278-001 May 31, 2016 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Adamas Pharma OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Adamas Pharma GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 Pharma OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018 ⤷  Free Forever Trial ⤷  Free Forever Trial
Adamas Pharma OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-003 Feb 16, 2018 ⤷  Free Forever Trial ⤷  Free Forever Trial
Adamas Pharma OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Dow
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