MEMANTINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Memantine Hydrochloride, and when can generic versions of Memantine Hydrochloride launch?
Memantine Hydrochloride is a drug marketed by Amneal Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Lupin, Macleods Pharms, Ph Health, Rising, Sun Pharm, Vitruvias, Yichang Humanwell, Zydus Pharms, Apozeal Pharms, Chartwell Molecular, Medley Pharms, Ajanta Pharma Ltd, Alembic, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Orbion Pharms, Pointview Hldings, Puracap Labs Blu, Puracap Pharm Llc, Renata, Strides Pharma, Teva Pharms, Torrent, Unichem, Upsher Smith Labs, Yiling, Zydus Lifesciences, Amneal, and Xiamen Lp Pharm Co. and is included in forty-seven NDAs.
The generic ingredient in MEMANTINE HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are two drug master file entries for this compound. Six 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
| US Patents: | 0 |
| Applicants: | 38 |
| NDAs: | 47 |
| Finished Product Suppliers / Packagers: | 38 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 260 |
| Patent Applications: | 4,062 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MEMANTINE HYDROCHLORIDE |
| What excipients (inactive ingredients) are in MEMANTINE HYDROCHLORIDE? | MEMANTINE HYDROCHLORIDE excipients list |
| DailyMed Link: | MEMANTINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for MEMANTINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Herlev Hospital | PHASE2 |
| Rune Skovgaard Rasmussen | PHASE2 |
| Case Comprehensive Cancer Center | PHASE2 |
Pharmacology for MEMANTINE HYDROCHLORIDE
| Drug Class | N-methyl-D-aspartate Receptor Antagonist |
| Mechanism of Action | NMDA Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for MEMANTINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for MEMANTINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for MEMANTINE HYDROCHLORIDE
| 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 |
| NAMENDA | Tablets | memantine hydrochloride | 5 mg and 10 mg | 021487 | 14 | 2007-10-16 |
US Patents and Regulatory Information for MEMANTINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lannett Co Inc | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 207236-001 | Nov 10, 2016 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Upsher Smith Labs | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 090043-002 | Jul 31, 2015 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Yichang Humanwell | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211100-001 | Apr 2, 2021 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >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
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Merz Pharmaceuticals GmbH | Memantine Merz | memantine hydrochloride | EMEA/H/C/002711Treatment 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 |
