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 Adamas Pharma, Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Heritage Pharma, Invagen Pharms, Invatech, Lannett Co Inc, Rubicon, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Solvay, Endo Pharms, Anda Repository, Cmp Pharma Inc, G And W Labs Inc, Hi Tech Pharma, Pharm Assoc, Teva Pharms, Vintage, Wockhardt Bio Ag, Osmotica Pharm, and Jubilant Generics, and is included in thirty-five NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amantadine hydrochloride has thirty-four patent family members in ten countries.

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

Summary for amantadine hydrochloride

International Patents:	34
US Patents:	22
Tradenames:	5
Applicants:	27
NDAs:	35
Drug Master File Entries:	7
Suppliers / Packagers:	31
Bulk Api Vendors:	129
Clinical Trials:	100
Patent Applications:	2,358
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amantadine hydrochloride
DailyMed Link:	amantadine hydrochloride at DailyMed

Recent Clinical Trials for amantadine hydrochloride

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

Sponsor	Phase
Ever Neuro Pharma GmbH	Phase 4
Adamas Pharmaceuticals, Inc.	Phase 4
Konkuk University Medical Center	Phase 4

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	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

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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
Adamas Pharma	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		RX	Yes	No	Start Trial	Start Trial				Start Trial
Adamas Pharma	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017		RX	Yes	No	Start Trial	Start Trial				Start Trial
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Invagen Pharms	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	207570-001	Sep 30, 2016	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Solvay	SYMADINE	amantadine hydrochloride	CAPSULE;ORAL	071000-001	Sep 4, 1986		DISCN	No	No	Start Trial	Start Trial				Start Trial
Vintage	AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	SYRUP;ORAL	077992-001	Dec 12, 2006		DISCN	No	No	Start Trial	Start Trial				Start 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
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018	Start Trial	Start Trial
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018	Start Trial	Start Trial
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018	Start Trial	Start 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	Estimated Expiration
Australia	2010325960	Start Trial
European Patent Office	2506709	Start Trial
Japan	5885668	Start Trial
European Patent Office	3132793	Start Trial
Japan	2017019874	Start Trial
China	106389381	Start Trial
Japan	6038203	Start Trial
>Country	>Patent Number	>Estimated Expiration

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