DrugPatentWatch Database Preview
NAMENDA XR Drug Profile
» See Plans and Pricing
Which patents cover Namenda Xr, and when can generic versions of Namenda Xr launch?
Namenda Xr is a drug marketed by Forest Labs Llc and is included in one NDA. There are seven patents protecting this drug and four Paragraph IV challenges.
This drug has seventy patent family members in twenty countries.
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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Namenda Xr
A generic version of NAMENDA XR was approved as memantine hydrochloride by DR REDDYS LABS LTD on April 14th, 2010.
Summary for NAMENDA XR
| International Patents: | 70 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 63 |
| Patent Applications: | 1,767 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NAMENDA XR |
| Drug Sales Revenues: | Drug sales revenues for NAMENDA XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NAMENDA XR |
| DailyMed Link: | NAMENDA XR at DailyMed |
See drug prices for NAMENDA XR
Recent Clinical Trials for NAMENDA XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 3 |
| NRG Oncology | Phase 3 |
| National Cancer Institute (NCI) | Early Phase 1 |
Pharmacology for NAMENDA XR
| Drug Class | N-methyl-D-aspartate Receptor Antagonist |
| Mechanism of Action | NMDA Receptor Antagonists |
Paragraph IV (Patent) Challenges for NAMENDA XR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NAMENDA XR | CAPSULE, EXTENDED RELEASE;ORAL | memantine hydrochloride | 022525 | 2013-06-10 |
US Patents and Regulatory Information for NAMENDA XR
Expired US Patents for NAMENDA XR
| 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 | Get Started for $10 | Get Started for $10 |
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-001 | Jun 21, 2010 | Get Started for $10 | Get Started for $10 |
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-002 | Jun 21, 2010 | Get Started for $10 | Get Started for $10 |
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NAMENDA XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2008535867 | Get Started for $10 |
| Brazil | PI0512177 | Get Started for $10 |
| China | 101686945 | Get Started for $10 |
| World Intellectual Property Organization (WIPO) | 2006121560 | Get Started for $10 |
| Mexico | 2007006120 | Get Started for $10 |
| Japan | 2821233 | Get Started for $10 |
| European Patent Office | 1827385 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NAMENDA XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0392059 | 0290025-6 | Sweden | Get Started for $10 | PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515 |
| 0392059 | SPC/GB02/046 | United Kingdom | Get Started for $10 | PRODUCT NAME: MEMANTINE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/02/219/001 20020515; UK EU/1/02/219/002 20020515; UK EU/1/02/219/003 20020515; UK EU/1/02/219/004 20020515; UK EU/1/02/219/005 20020515; UK EU/1/02/219/006 20020515 |
| 0392059 | 2002C/035 | Belgium | Get Started for $10 | PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517 |
| 0392059 | 90988 | Luxembourg | Get Started for $10 | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
