Amantadine hydrochloride - Generic Drug Details

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What are the generic drug 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 Zydus, Supernus Pharms, 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, 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 forty-two NDAs. There are thirty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are five drug master file entries for amantadine hydrochloride. Thirty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for amantadine hydrochloride

International Patents:	46
US Patents:	30
Tradenames:	5
Applicants:	32
NDAs:	42
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	114
Patent Applications:	2,684
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amantadine hydrochloride
What excipients (inactive ingredients) are in amantadine hydrochloride?	amantadine hydrochloride excipients list
DailyMed Link:	amantadine hydrochloride at DailyMed

Recent Clinical Trials for amantadine hydrochloride

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

Sponsor	Phase
Ohio State University	Phase 1
Ain Shams University	Phase 3
Shahid Beheshti University of Medical Sciences	Phase 2

See all amantadine hydrochloride clinical trials

Generic filers with tentative approvals for AMANTADINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for amantadine hydrochloride

Drug Class	Influenza A M2 Protein Inhibitor
Mechanism of Action	M2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for amantadine hydrochloride

Analgesics, Non-Narcotic
Antiparkinson Agents
Antiviral Agents
Dopamine Agents

Anatomical Therapeutic Chemical (ATC) Classes for amantadine hydrochloride

N04BB	Adamantane derivatives
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Invagen Pharms	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	TABLET;ORAL	207571-001	Jan 31, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		DISCN	Yes	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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018	⤷ Sign Up	⤷ Sign Up
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018	⤷ Sign Up	⤷ Sign Up
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for amantadine hydrochloride

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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)	⤷ Sign Up
European Patent Office	2506709	COMPOSITIONS D'AMANTADINE ET PROCÉDÉS D'UTILISATION ASSOCIÉS (AMANTADINE COMPOSITIONS AND METHODS OF USE)	⤷ Sign Up
Mexico	2012006320	COMPOSICIONES DE AMANTADINA Y METODOS PARA SU USO. (AMANTADINE COMPOSITIONS AND METHODS OF USE.)	⤷ Sign Up
European Patent Office	3672581	COMPOSITIONS D'AMANTADINE, LEURS PRÉPARATION, ET PROCÉDÉS D'UTILISATION (AMANTADINE COMPOSITIONS, PREPARATIONS THEREOF, AND METHODS OF USE)	⤷ Sign Up
Japan	2015131818	アマンタジン組成物および使用方法 (AMANTADINE COMPOSITIONS AND METHODS OF USE)	⤷ Sign Up
European Patent Office	1834638	DISPOSITIF OSMOTIQUE CONTENANT DE L'AMANTADINE ET UN SEL OSMOTIQUE (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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