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NAMENDA XR Drug Profile
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See Plans and PricingWhich 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 seventy patent family members in twenty countries.
The generic ingredient in NAMENDA XR is memantine hydrochloride. There are twenty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the memantine hydrochloride profile page.
US ANDA 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: | 70 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 103 |
| Clinical Trials: | 61 |
| Patent Applications: | 1,591 |
| 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 |
|---|---|
| National Cancer Institute (NCI) | Early Phase 1 |
| Mayo Clinic | Early Phase 1 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 |
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 |
| Forest Laboratories, LLC v. Macleods Pharmaceuticals, Ltd. | 2017-06-02 |
| Allergan Sales 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 |
Paragraph IV (Patent) Challenges for NAMENDA XR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NAMENDA XR | CAPSULE, EXTENDED RELEASE;ORAL | memantine hydrochloride | 022525 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||
| >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 |
International Patents for NAMENDA XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Singapore | 157415 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006009769 | Start Trial |
| Israel | 179991 | Start Trial |
| Canada | 2556216 | Start Trial |
| Australia | 2005309601 | 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 |
