Details for New Drug Application (NDA): 022525

✉ Email this page to a colleague

NDA 022525 describes NAMENDA XR, which is a drug marketed by Abbvie and is included in one NDA. There is one patent protecting this drug and four Paragraph IV challenges. Additional details are available on the NAMENDA XR profile page.

The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.

Summary for 022525

Tradename:	NAMENDA XR
Applicant:	Abbvie
Ingredient:	memantine hydrochloride
Patents:	1

Pharmacology for NDA: 022525

Mechanism of Action	NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 022525

Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 21, 2010	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Sep 24, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	14MG
Approval Date:	Jun 21, 2010	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Sep 24, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	21MG
Approval Date:	Jun 21, 2010	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Sep 24, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022525

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-001	Jun 21, 2010	⤷ Subscribe	⤷ Subscribe
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-004	Jun 21, 2010	⤷ Subscribe	⤷ Subscribe
Abbvie	NAMENDA XR	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022525-003	Jun 21, 2010	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.