NAMENDA XR Drug Patent Profile
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Which patents cover Namenda Xr, and when can generic versions of Namenda Xr launch?
Namenda Xr is a drug marketed by Allergan and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has eleven patent family members in ten countries.
The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Thirty-nine 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: | 11 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 111 |
Clinical Trials: | 73 |
Patent Applications: | 2,688 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
---|---|
Medical College of Wisconsin | Phase 2 |
Children's Oncology Group | Phase 3 |
Mayo Clinic | Early Phase 1 |
Pharmacology for NAMENDA XR
Drug Class | N-methyl-D-aspartate Receptor Antagonist |
Mechanism of Action | NMDA Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for NAMENDA XR
Paragraph IV (Patent) Challenges for NAMENDA XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NAMENDA XR | Extended-release Capsules | memantine hydrochloride | 7 mg, 14 mg, 21 mg, and 28 mg | 022525 | 1 | 2013-06-10 |
US Patents and Regulatory Information for NAMENDA XR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-001 | Jun 21, 2010 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Allergan | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Allergan | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-002 | Jun 21, 2010 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Allergan | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-003 | Jun 21, 2010 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for NAMENDA XR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-003 | Jun 21, 2010 | See Plans and Pricing | See Plans and Pricing |
Allergan | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-001 | Jun 21, 2010 | See Plans and Pricing | See Plans and Pricing |
Allergan | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | See Plans and Pricing | See Plans and Pricing |
Allergan | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-002 | Jun 21, 2010 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NAMENDA XR
See the table below for patents covering NAMENDA XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2554959 | COMBINAISON D'ANTAGONISTE DE RECEPTEUR NMDA ET D'INHIBITEUR MAO OU GADPF POUR LE TRAITEMENT D'AFFECTIONS LIEES AU SYSTEME NERVEUX CENTRAL (COMBINATION OF A NMDA RECEPTOR ANTAGONIST AND A MAO-INHIBITOR OR A GADPF-INHIBITOR FOR THE TREATMENT OF CENTRAL NERVOUS SYSTEM-RELATED CONDITIONS) | See Plans and Pricing |
Russian Federation | 2007122410 | КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОСНОВУ ИЛИ ПОКРЫТИЕ ДЛЯ ЗАМЕДЛЕННОГО ВЫСВОБОЖДЕНИЯ И АНТАГОНИСТ NMDA-РЕЦЕПТОРА, СПОСОБ ВВЕДЕНИЯ ТАКОГО NMDA-АНТАГОНИСТА СУБЪЕКТУ | See Plans and Pricing |
Israel | 183384 | See Plans and Pricing | |
Hungary | T58200 | See Plans and Pricing | |
China | 101247795 | Methods and compositions for treatment of CNS disorders | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NAMENDA XR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0392059 | 2002C/035 | Belgium | See Plans and Pricing | PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517 |
0392059 | SPC/GB02/046 | United Kingdom | See Plans and Pricing | 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 | 0290025-6 | Sweden | See Plans and Pricing | PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515 |
0392059 | 90988 | Luxembourg | See Plans and Pricing | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |