Memantine hydrochloride - Generic Drug Details
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What are the generic sources for memantine hydrochloride and what is the scope of freedom to operate?
Memantine hydrochloride
is the generic ingredient in three branded drugs marketed by Amneal Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Rising, Sun Pharm, Xiamen Lp Pharm Co, Yichang Humanwell, Zydus Pharms, Abbvie, Chartwell Molecular, Macleods Pharms Ltd, Sciegen Pharms Inc, Seton Pharms, Allergan, Acme Labs, Ajanta Pharma Ltd, Alembic, Allied, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Polygen Pharms, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent, Unichem, Upsher Smith Labs, Yiling, and Zydus Lifesciences, and is included in forty-five NDAs. There is one patent protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Memantine hydrochloride has ten patent family members in nine countries.
There are twenty-eight drug master file entries for memantine hydrochloride. Forty-one suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for memantine hydrochloride
International Patents: | 10 |
US Patents: | 1 |
Tradenames: | 3 |
Applicants: | 37 |
NDAs: | 45 |
Drug Master File Entries: | 28 |
Finished Product Suppliers / Packagers: | 41 |
Raw Ingredient (Bulk) Api Vendors: | 121 |
Clinical Trials: | 243 |
Patent Applications: | 4,101 |
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 |
---|---|
NeuroSense Therapeutics Ltd. | Phase 2 |
Mansoura University | Phase 1/Phase 2 |
Simon Ducharme, MD | Phase 3 |
Generic filers with tentative approvals for MEMANTINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 28MG | CAPSULE, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 21MG | CAPSULE, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 14MG | CAPSULE, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206135-002 | Nov 22, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Jubilant Generics | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 091585-002 | Oct 13, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Zydus Pharms | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 203293-003 | Aug 3, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rising | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | TABLET;ORAL | 079225-002 | Jan 30, 2015 | DISCN | 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 |
Expired US Patents for memantine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-001 | Jun 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | NAMENDA XR | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022525-004 | Jun 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | NAMENDA | memantine hydrochloride | SOLUTION;ORAL | 021627-001 | Apr 18, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | NAMENDA | memantine hydrochloride | TABLET;ORAL | 021487-001 | Oct 16, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for memantine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2006009769 | ⤷ Sign Up | |
Mexico | PA06014587 | FORMULACIONES DE LIBERACION MODIFICADA DE FORMULACIONES DE DOSIFICACION ORAL DE MEMANTINA. (MODIFIED RELEASE FORMULATION OF MEMANTINE.) | ⤷ Sign Up |
Eurasian Patent Organization | 200700049 | ПРЕПАРАТИВНЫЕ ФОРМЫ ОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ ФОРМ МЕМАНТИНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ | ⤷ Sign Up |
Japan | 2008503475 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for memantine hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0392059 | 2002C/035 | Belgium | ⤷ Sign Up | PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517 |
0392059 | SPC/GB02/046 | United Kingdom | ⤷ Sign Up | 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 |
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