Generated: December 13, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022525
« Back to Dashboard
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 suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.
Pharmacology for NDA: 022525
Medical Subject Heading (MeSH) Categories for 022525
Complete Access Available with Subscription
Summary for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||CAPSULE, EXTENDED RELEASE;ORAL||Strength||7MG|
|Approval Date:||Jun 21, 2010||TE:||AB||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Jul 3, 2017
|Regulatory Exclusivity Use:||INFORMATION ADDED TO THE 8.4 PEDIATRIC USE SECTION ON THE USE OF MEMANTINE IN CHILDREN AGES 6-12 YEARS WITH AUTISM SPECTRUM DISORDER|
|Regulatory Exclusivity Expiration:||Jan 3, 2018
|Regulatory Exclusivity Use:||PEDIATRIC EXCLUSIVITY|
|Patent:||► Subscribe||Patent Expiration:||Sep 24, 2029||Product Flag?||Substance Flag?||Delist Request?||Y|
Expired Orange Book Patents for NDA: 022525
Serving leading biopharmaceutical companies globally:
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.