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Last Updated: April 19, 2024

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, 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-nine 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-two suppliers are listed for this compound.

Summary for amantadine hydrochloride

International Patents:	45
US Patents:	29
Tradenames:	5
Applicants:	31
NDAs:	40
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	112
Patent Applications:	2,684
Formulation / Manufacturing:	see details
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
Shahid Beheshti University of Medical Sciences	Phase 2
Hospital San Carlos, Madrid	Phase 3
University Hospital Tuebingen	Phase 2

See all amantadine hydrochloride clinical trials

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

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
Alembic	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	TABLET;ORAL	214284-001	Oct 15, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Adamas Operations	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017		RX	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				⤷ Try a Trial
Zydus Pharms	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	208278-001	May 31, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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				⤷ Try a Trial
Adamas Operations	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No	⤷ 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

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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	⤷ Try a Trial	⤷ Try a Trial
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
>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
Japan	2023009251	アマンタジン組成物、その調製、および使用方法	⤷ Try a Trial
Spain	2549581		⤷ Try a Trial
Brazil	112012013487	COMPOSIÇÕES DE AMANTADINA E MÉTODOS DE USO	⤷ Try a Trial
Canada	2589479	DISPOSITIF OSMOTIQUE CONTENANT DE L'AMANTADINE ET UN SEL OSMOTIQUE (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT)	⤷ Try a Trial
Mexico	2007006472	DISPOSITIVO OSMOTICO QUE CONTIENE AMANTADINA Y UNA SAL OSMOTICA. (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT.)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006058236		⤷ Try a Trial
Canada	2782556	COMPOSITIONS D'AMANTADINE ET PROCEDES D'UTILISATION ASSOCIES (AMANTADINE COMPOSITIONS AND METHODS OF USE)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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