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, 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, Chartwell Rx, Cmp Pharma Inc, G And W Labs Inc, Genus, Pharm Assoc, Teva Pharms, Vintage, Wockhardt Bio Ag, 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-two patent family members in eleven countries.

There are five drug master file entries for amantadine hydrochloride. Thirty suppliers are listed for this compound.

Summary for amantadine hydrochloride

International Patents:	42
US Patents:	28
Tradenames:	5
Applicants:	28
NDAs:	39
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	144
Clinical Trials:	110
Patent Applications:	2,566
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
University Hospital Tuebingen	Phase 2
All India Institute of Medical Sciences, Bhubaneswar	Phase 4
Indian Council of Medical Research	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

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
Adamas Pharma	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Adamas Pharma	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
Adamas Pharma	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				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

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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	See Plans and Pricing	See Plans and Pricing
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018	See Plans and Pricing	See Plans and Pricing
Adamas Pharma	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	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

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Country	Patent Number	Title	Estimated Expiration
China	111372578	金刚烷胺组合物、其制备和使用方法 (AMANTADINE COMPOSITIONS, PREPARATIONS THEREOF, AND METHODS OF USE)	See Plans and Pricing
Japan	6038203		See Plans and Pricing
World Intellectual Property Organization (WIPO)	2011069010		See Plans and Pricing
Canada	2589479	DISPOSITIF OSMOTIQUE CONTENANT DE L'AMANTADINE ET UN SEL OSMOTIQUE (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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