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Last Updated: January 30, 2023

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 Pharms Ltd, Bionpharma Inc, Chartwell Molecular, Heritage Pharma, Invagen Pharms, Novelgenix Theraps, Rubicon, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Solvay, Endo Pharms, Akorn, Anda Repository, Chartwell Rx, Cmp Pharma Inc, G And W Labs Inc, Pharm Assoc, Teva Pharms, Vintage, Xttrium Labs Inc, Edenbridge Pharms, and Jubilant Generics, and is included in thirty-nine NDAs. There are twenty-eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amantadine hydrochloride has forty-three 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
University Hospital TuebingenPhase 2
All India Institute of Medical Sciences, BhubaneswarPhase 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 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 209410-003 Feb 16, 2018 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jubilant Generics AMANTADINE HYDROCHLORIDE amantadine hydrochloride TABLET;ORAL 210403-001 Feb 7, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Adamas Operations GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 209410-003 Feb 16, 2018 See Plans and Pricing See Plans and Pricing
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018 See Plans and Pricing See Plans and Pricing
Adamas Operations OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for amantadine hydrochloride

Country Patent Number Title Estimated Expiration
Australia 2015202356 Amantadine compositions and methods of use See Plans and Pricing
China 106389381 金刚烷胺组合物及其使用方法 (Amantadine compositions and methods of use) See Plans and Pricing
Mexico 365650 COMPOSICIONES DE AMANTADINA Y METODOS PARA SU USO. (AMANTADINE COMPOSITIONS AND METHODS OF USE.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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