DrugPatentWatch Database Preview
NAMENDA XR Drug Profile
Which patents cover Namenda Xr, and what generic alternatives are available?
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 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-two 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: | 2 |
| Bulk Api Vendors: | 100 |
| Clinical Trials: | 60 |
| Patent Applications: | 1,549 |
| 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 |
|---|---|
| University of North Carolina, Chapel Hill | Phase 2 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 |
| Wayne State University | Phase 3 |
Recent Litigation for NAMENDA XR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ADAMAS PHARMA, LLC v. SANDOZ INC. | 2018-05-10 |
| Allergan Sales LLC v. Macleods Pharmaceuticals, Ltd. | 2017-06-02 |
| Forest Laboratories, LLC v. Macleods Pharmaceuticals, Ltd. | 2017-06-02 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Ranbaxy, Inc. | 2014-12-18 |
Pharmacology for NAMENDA XR
| Drug Class | N-methyl-D-aspartate Receptor Antagonist |
| Mechanism of Action | NMDA Receptor Antagonists |
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-Dimethyl-5-aminoadamantane hydrochloride, 99% |
| 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 HCL |
| 3,5-dimethyladamantan-1-amine hy-drochloride |
| 3,5-dimethyladamantan-1-amine hydrochloride |
| 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 |
| 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 |
| 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-145 |
| 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 |
| Memary |
| Memary (TN) |
| MFCD00214336 |
| MFCD00214336 (97%) |
| 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 |
| SR-01000075458-3 |
| SR-01000075458-8 |
| ST088119 |
| SUN Y7017 |
| SUN-Y7017 |
| SW060653-4 |
| SY057917 |
| 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 |
| Tricyclo[3.3.1.13,7]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 | 022525-001 | Jun 21, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-003 | Jun 21, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-002 | Jun 21, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-001 | Jun 21, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-002 | Jun 21, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-001 | Jun 21, 2010 | Start Trial | Start Trial |
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-003 | Jun 21, 2010 | Start Trial | Start Trial |
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | Start Trial | Start Trial |
| Forest Labs Llc | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-002 | Jun 21, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for NAMENDA XR
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Capsules | 28 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Extended-release Capsules | 7 mg, 14 mg, 21 mg, and 28 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Extended-release Capsules | 7 mg, 14 mg, 21 mg, and 28 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Extended-release Capsules | 7 mg, 14 mg, 21 mg | ➤ Subscribe | Start Trial |
International Patents for NAMENDA XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 101686945 | Start Trial |
| China | 101060830 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006009769 | Start Trial |
| Hong Kong | 1103517 | Start Trial |
| Russian Federation | 2007140348 | Start Trial |
| European Patent Office | 1715843 | Start Trial |
| European Patent Office | 1874282 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NAMENDA XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0392059 | 2002C/035 | Belgium | Start Trial | PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517 |
| 0392059 | SPC/GB02/046 | United Kingdom | Start 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 |
