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, Anchen Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Lupin Ltd, Rising, Sun Pharm, Xiamen Lp Pharm Co, Yichang Humanwell, Zydus Pharms, Apozeal Pharms, Chartwell Molecular, Macleods Pharms Ltd, Seton Pharms, Ajanta Pharma Ltd, Alembic, Celltrion, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Polygen Pharms, Puracap Pharm Llc, Renata, Strides Pharma, Teva Pharms, Torrent, Unichem, Upsher Smith Labs, Yiling, and Zydus Lifesciences. and is included in forty-four NDAs.
The generic ingredient in MEMANTINE 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.
Summary for MEMANTINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 35 |
| NDAs: | 44 |
| Finished Product Suppliers / Packagers: | 38 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 242 |
| Patent Applications: | 2,629 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Mansoura University | Phase 1/Phase 2 |
| Alzheimer's Drug Discovery Foundation | Phase 3 |
| University of Chicago | Phase 2/Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin Ltd | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 090051-001 | Apr 10, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Lifesciences | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 090961-002 | Jul 10, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 203293-001 | Aug 3, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205905-004 | Sep 28, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Strides Pharma | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 202350-001 | May 23, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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/002711 Treatment 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 |
