NAMENDA Drug Patent Profile
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Which patents cover Namenda, and what generic alternatives are available?
Namenda is a drug marketed by Allergan and Abbvie and is included in three NDAs. There is one patent protecting this drug and one Paragraph IV challenge.
The generic ingredient in NAMENDA 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
A generic version of NAMENDA was approved as memantine hydrochloride by DR REDDYS LABS LTD on April 14th, 2010.
Summary for NAMENDA
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 121 |
Clinical Trials: | 76 |
Patent Applications: | 2,539 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NAMENDA |
What excipients (inactive ingredients) are in NAMENDA? | NAMENDA excipients list |
DailyMed Link: | NAMENDA at DailyMed |
Recent Clinical Trials for NAMENDA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Chicago | Phase 2/Phase 3 |
Children's Hospital Medical Center, Cincinnati | Early Phase 1 |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Early Phase 1 |
Pharmacology for NAMENDA
Drug Class | N-methyl-D-aspartate Receptor Antagonist |
Mechanism of Action | NMDA Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for NAMENDA
Paragraph IV (Patent) Challenges for NAMENDA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NAMENDA | Tablets | memantine hydrochloride | 5 mg and 10 mg | 021487 | 14 | 2007-10-16 |
US Patents and Regulatory Information for NAMENDA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | NAMENDA | memantine hydrochloride | SOLUTION;ORAL | 021627-001 | Apr 18, 2005 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-001 | Jun 21, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Abbvie | NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487-001 | Oct 16, 2003 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbvie | NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487-002 | Oct 16, 2003 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487-001 | Oct 16, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487-001 | Oct 16, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | NAMENDA | memantine hydrochloride | SOLUTION;ORAL | 021627-001 | Apr 18, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487-002 | Oct 16, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487-002 | Oct 16, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NAMENDA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Merz Pharmaceuticals GmbH | Memantine Merz | memantine hydrochloride | EMEA/H/C/002711 Treatment of patients with moderate to severe Alzheimer’s disease. |
Authorised | no | no | no | 2012-11-22 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for NAMENDA
See the table below for patents covering NAMENDA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 202474 | ⤷ Try a Trial | |
Japan | 2821233 | ⤷ Try a Trial | |
Denmark | 91690 | ⤷ Try a Trial | |
Australia | 705888 | ⤷ Try a Trial | |
Japan | 2006077034 | MEDICAMENT FOR PREVENTING NMDA RECEPTOR-MEDIATED NEURAL DAMAGE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NAMENDA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0392059 | 90988 | Luxembourg | ⤷ Try a Trial | |
0392059 | 2002C/035 | Belgium | ⤷ Try a Trial | PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517 |
0392059 | 0290025-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515 |
0392059 | SPC/GB02/046 | United Kingdom | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |