MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Drug Patent Profile
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Which patents cover Memantine Hydrochloride And Donepezil Hydrochloride, and when can generic versions of Memantine Hydrochloride And Donepezil Hydrochloride launch?
Memantine Hydrochloride And Donepezil Hydrochloride is a drug marketed by Amneal Pharms and Ani Pharms and is included in two NDAs.
The generic ingredient in MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
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Summary for MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 26 |
| DailyMed Link: | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NeuroSense Therapeutics Ltd. | Phase 2 |
| Peking Union Medical College Hospital | Phase 2 |
| Tongji University | Phase 2 |
See all MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE clinical trials
Pharmacology for MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
| Drug Class | Cholinesterase Inhibitor N-methyl-D-aspartate Receptor Antagonist |
| Mechanism of Action | Cholinesterase Inhibitors NMDA Receptor Antagonists |
US Patents and Regulatory Information for MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208328-001 | Jan 27, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal Pharms | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208328-002 | Jan 27, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ani Pharms | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208237-001 | Dec 15, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| H. Lundbeck A/S | Acrescent | memantine hydrochloride, donepezil hydrochloride | EMEA/H/C/002424 Treatment of Alzheimers disease |
Refused | no | no | no | 2013-02-20 | |
| Merz Pharmaceuticals GmbH | Balaxur | memantine hydrochloride, donepezil hydrochloride | EMEA/H/C/002708 |
Refused | no | no | no | 2013-02-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
