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Details for New Drug Application (NDA): 022525

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NDA 022525 describes NAMENDA XR, which is a drug marketed by Forest Labs Llc and is included in one NDA. It is available from three suppliers. There are eight patents 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. Thirty-five suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the memantine hydrochloride profile page.

Summary for NDA: 022525

Tradename:
NAMENDA XR
Applicant:
Forest Labs Llc
Ingredient:
memantine hydrochloride
Patents:8
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022525

Mechanism of ActionNMDA Receptor Antagonists

Suppliers and Packaging for NDA: 022525

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 022525 NDA Allergan, Inc. 0456-3400 0456-3400-29 1 KIT in 1 BLISTER PACK (0456-3400-29)
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 022525 NDA Allergan, Inc. 0456-3407 0456-3407-33 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0456-3407-33)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength7MG
Approval Date:Jun 21, 2010TE:ABRLD:No
Patent:5,061,703*PEDPatent Expiration:Oct 11, 2015Product Flag?Substance Flag?Delist Request?
Patent:8,039,009*PEDPatent Expiration:Sep 24, 2029Product Flag?Substance Flag?Delist Request?Y
Patent:8,168,209*PEDPatent Expiration:May 22, 2026Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 022525

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-001Jun 21, 20105,061,703*PED► subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 20105,061,703*PED► subscribe
Forest Labs Llc
NAMENDA XR
memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022525-002Jun 21, 20105,061,703*PED► subscribe
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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 verifification 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.

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