DrugPatentWatch Database Preview
NAMENDA XR Drug Profile
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Which patents cover Namenda Xr, and what generic alternatives are available?
This drug has sixty-nine patent family members in nineteen countries.
The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.
Summary for NAMENDA XR
| International Patents: | 69 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 86 |
| Clinical Trials: | 56 |
| Patent Applications: | 1,341 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NAMENDA XR |
| DailyMed Link: | NAMENDA XR at DailyMed |
Pharmacology for NAMENDA XR
| Drug Class | N-methyl-D-aspartate Receptor Antagonist |
| Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for NAMENDA XR
Synonyms for NAMENDA XR
| (3,5-Dimethyl-1-adamantyl)amine hydrochloride |
| 1-amino-3,5-dimethyl-adamantane hydrochloride |
| 1-Amino-3,5-dimethyladamantane Hydrochloride |
| 1,3-Dimethylaminoadamantane hydrochloride |
| 19982-08-2 (Parent) |
| 3,5-Dimethyl-1-adamantanamine hydrochloride |
| 3,5-Dimethyl-1-adamantanamineHydrochloride |
| 3,5-Dimethyl-1-aminoadamantane HCl |
| 3,5-Dimethyl-1-aminoadamantane hydrochloride |
| 3,5-Dimethyl-tricyclo[3.3.1.13,7]decan-1-amine hydrochloride |
| 3,5-dimethyladamantan-1-amine hy-drochloride |
| 3,5-dimethyladamantan-1-amine hydrochloride |
| 3,5-dimethyladamantan-1-amine;hydrochloride |
| 3,5-dimethyladamantan-1-aminium chloride |
| 3,5-dimethyladamantanylamine, chloride |
| 3,5-Dimethylamantadine hydrochloride |
| 3,5-dimethyltricyclo(3.3.1.1(3,7))decan-1-amine hydrochloride |
| 3,5-Dimethyltricyclo(3.3.1.1(sup 3,7))decan-1-amine hydrochloride |
| 3,5-Dimethyltricyclo(3.3.1.13,7)decan-1-amine hydrochloride |
| 3,5-dimethyltricyclo[3.3.1.13,7]decan-1-amine hydrochloride |
| 41100-52-1 |
| 4CH-006120 |
| AB0013351 |
| AB2000447 |
| AC-559 |
| AC1L492E |
| ACMC-209jif |
| AK-44671 |
| Akatinol |
| AKOS015889460 |
| AM20070534 |
| AN-15700 |
| ANW-29557 |
| AOB5318 |
| AS-13331 |
| AX8033628 |
| Axura |
| BC208848 |
| BCP9000253 |
| BG0374 |
| BR-44671 |
| CCG-39018 |
| CHEBI:64323 |
| CHEMBL1699 |
| CPD000058926 |
| CPD000875213 |
| CS-2422 |
| CTK8B1656 |
| D 145 |
| D-145 |
| D04905 |
| D3608 |
| Ebixa |
| Ebixza |
| EINECS 255-219-6 |
| EU-0100861 |
| FT-0650723 |
| H908 |
| HMS1571C17 |
| HMS1921H03 |
| HY-B0365A |
| I01-2072 |
| J10287 |
| JY0WD0UA60 |
| KS-00000X1M |
| KSC911M5N |
| LDDHMLJTFXJGPI-UHFFFAOYSA-N |
| LP00861 |
| M 9292 |
| M-2015 |
| Mantine |
| MCULE-6635165082 |
| Memantin hydrochloride |
| Memantine (hydrochloride) |
| Memantine HCL |
| MEMANTINE HYDROCHLORIDE |
| Memantine hydrochloride (JAN/USAN) |
| Memantine hydrochloride (Namenda) |
| Memantine hydrochloride [USAN] |
| memantine.HCl |
| Memantinehydrochloride |
| Memary |
| Memary (TN) |
| MFCD00214336 |
| MLS001332605 |
| MLS001332606 |
| MolPort-003-666-358 |
| MRZ-2/145 |
| N06DX01 |
| Namenda |
| Namenda (TN) |
| NC00680 |
| NCGC00094186-01 |
| NCGC00094186-02 |
| NCGC00094186-03 |
| NCGC00261546-01 |
| NMI-131 |
| NSC 102290 |
| NSC-102290 |
| NSC-757843 |
| NSC102290 |
| NSC757843 |
| Pharmakon1600-01501121 |
| RTR-016345 |
| s2043 |
| SAM001246743 |
| SAM002699890 |
| SBB003390 |
| SCHEMBL3053 |
| SMR000875213 |
| SPECTRUM1501121 |
| SR-01000075458 |
| SR-01000075458-1 |
| ST088119 |
| SUN Y7017 |
| SUN-Y7017 |
| Tox21_500861 |
| TR-016345 |
| Tricyclo(3.3.1.1(3,7))decan-1-amine, 3,5-dimethyl-, hydrochloride |
| Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, 3,5-dimethyl-, hydrochloride |
| UNII-JY0WD0UA60 |
| Z1551429722 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-001 | Jun 21, 2010 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-003 | Jun 21, 2010 | AB | RX | 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 |
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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 | 022525-004 | Jun 21, 2010 | ➤ Sign Up | ➤ Sign Up |
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-003 | Jun 21, 2010 | ➤ Sign Up | ➤ Sign Up |
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-001 | Jun 21, 2010 | ➤ Sign Up | ➤ Sign Up |
| Forest Labs Llc | 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 |
Paragraph IV (Patent) Challenges for NAMENDA XR
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Capsules | 7 mg, 14 mg, 21 mg, and 28 mg | ➤ Subscribe | 2013-08-16 |
| ➤ Subscribe | Extended-release Capsules | 7 mg, 14 mg, 21 mg | ➤ Subscribe | 2013-06-17 |
| ➤ Subscribe | Extended-release Capsules | 28 mg | ➤ Subscribe | 2013-06-12 |
| ➤ Subscribe | Extended-release Capsules | 7 mg, 14 mg, 21 mg, and 28 mg | ➤ Subscribe | 2013-06-10 |
Non-Orange Book US Patents for NAMENDA XR
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,058,291 | Methods and compositions for the treatment of CNS-related conditions | ➤ Sign Up |
| 8,338,485 | Compositions for the treatment of CNS-related conditions | ➤ Sign Up |
| 8,338,486 | Methods for the treatment of CNS-related conditions | ➤ Sign Up |
| 2,012,045,508 | ➤ Sign Up | |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for NAMENDA XR
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 200700049 | ➤ Sign Up |
| European Patent Office | 1789028 | ➤ Sign Up |
| Israel | 186504 | ➤ Sign Up |
| European Patent Office | 1781261 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for NAMENDA XR
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 02C/035 | Belgium | ➤ Sign Up | PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517 |
| C/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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
