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 Abbvie and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has ten patent family members in nine 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.
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Summary for NAMENDA XR
| International Patents: | 10 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 76 |
| Patent Applications: | 2,539 |
| 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 |
|---|---|
| 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 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 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-001 | Jun 21, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-002 | Jun 21, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-003 | Jun 21, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-001 | Jun 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-003 | Jun 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-002 | Jun 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NAMENDA XR
| 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 XR
See the table below for patents covering NAMENDA XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Africa | 200709535 | Methods and compositions for the treatment of CNS-related conditions | ⤷ Sign Up |
| Mexico | PA06014587 | FORMULACIONES DE LIBERACION MODIFICADA DE FORMULACIONES DE DOSIFICACION ORAL DE MEMANTINA. (MODIFIED RELEASE FORMULATION OF MEMANTINE.) | ⤷ Sign Up |
| European Patent Office | 1827385 | COMPOSITION PHARMACEUTIQUE CONTENANT MEMANTINE DANS UNE FORME À LIBERATION PROLONGÉE POUR LE TRATIEMENT DE DEMENTIA (PHARMACEUTICAL COMPOSITION COMPRISING MEMANTINE IN AN EXTENDED DOSAGE RELEASE FORM FOR USE IN THE TREATMENT OF DEMENTIAS) | ⤷ Sign Up |
| China | 101060830 | Combination of a NMDA receptor antagonist and an anti-depressive drug mao-inhibitor or a gadph-inhibitor for the treatment of psychiatric conditions | ⤷ Sign Up |
| Japan | 2007522249 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NAMENDA XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0392059 | 90988 | Luxembourg | ⤷ Sign Up | |
| 0392059 | 0290025-6 | Sweden | ⤷ Sign Up | PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515 |
| 0392059 | 2002C/035 | Belgium | ⤷ Sign Up | PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517 |
| 0392059 | SPC/GB02/046 | United Kingdom | ⤷ Sign Up | 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 |
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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 verification 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.
ISSN: 2162-2639
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