Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Medtronic
Federal Trade Commission
US Army
Healthtrust
Queensland Health
Moodys
US Department of Justice
Farmers Insurance

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022525

« Back to Dashboard

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 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-three 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
Therapeutic Class:Antidementia Agents
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 N 0456-3400-29
NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525 NDA Allergan, Inc. 0456-3407 N 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:➤ Sign UpPatent Expiration:Sep 24, 2029Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent 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 022525-003 Jun 21, 2010 ➤ Sign Up ➤ Sign Up
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-001 Jun 21, 2010 ➤ Sign Up ➤ Sign Up
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-002 Jun 21, 2010 ➤ Sign Up ➤ Sign Up
Forest Labs Llc NAMENDA XR memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022525-004 Jun 21, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Fish and Richardson
US Department of Justice
Fuji
AstraZeneca
Baxter
Harvard Business School
Cantor Fitzgerald

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.