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Last Updated: November 4, 2024

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, Endo Operations, Lupin Ltd, Rising, Sun Pharm, Xiamen Lp Pharm Co, Yichang Humanwell, Zydus Pharms, Chartwell Molecular, Macleods Pharms Ltd, Sciegen Pharms Inc, Seton Pharms, 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-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.

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Drug patent expirations by year for MEMANTINE HYDROCHLORIDE
Recent Clinical Trials for MEMANTINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NeuroSense Therapeutics Ltd.Phase 2
Mansoura UniversityPhase 1/Phase 2
Simon Ducharme, MDPhase 3

See all MEMANTINE HYDROCHLORIDE clinical trials

Pharmacology for MEMANTINE HYDROCHLORIDE
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Lifesciences MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 090961-002 Jul 10, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203293-001 Aug 3, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm MEMANTINE HYDROCHLORIDE memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205905-004 Sep 28, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma MEMANTINE HYDROCHLORIDE memantine hydrochloride TABLET;ORAL 202350-001 May 23, 2017 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

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.