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Generated: November 15, 2018

DrugPatentWatch Database Preview

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 two suppliers. There are seven 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. Forty-two suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.
Summary for 022525
Tradename:NAMENDA XR
Applicant:Forest Labs Llc
Ingredient:memantine hydrochloride
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 022525
Mechanism of ActionNMDA Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 022525
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength7MG
Approval Date:Jun 21, 2010TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jan 3, 2018
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Try a Free TrialPatent Expiration:Sep 24, 2029Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:May 22, 2026Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022525

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-003 Jun 21, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-002 Jun 21, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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