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Generated: December 14, 2017

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Memantine hydrochloride - Generic Drug Details

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What are the generic sources for memantine hydrochloride and what is the scope of memantine hydrochloride patent protection?

Memantine hydrochloride
is the generic ingredient in three branded drugs marketed by Amneal Pharms, Anchen Pharms, Apotex Inc, Lupin Ltd, Mylan Pharms Inc, Sun Pharma Global, Zydus Pharms Usa Inc, Forest Labs Llc, Bio-pharm Inc, Macleods Pharms Ltd, Silarx Pharms Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Jubilant Generics, Orchid Hlthcare, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent Pharms Ltd, Unichem Labs Ltd, Upsher-smith Labs, and Wockhardt Ltd, and is included in thirty-three NDAs. There are seven patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for memantine hydrochloride. Forty suppliers are listed for this compound. There are three tentative approvals for this compound.

Pharmacology for memantine hydrochloride

Medical Subject Heading (MeSH) Categories for memantine hydrochloride

Tentative approvals for MEMANTINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe5MGTABLET; ORAL
u► Subscribe10MGTABLET; ORAL
u► Subscribe10MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Apotex IncMEMANTINE HYDROCHLORIDEmemantine hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL206135-004Nov 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Puracap Pharm LlcMEMANTINE HYDROCHLORIDEmemantine hydrochlorideTABLET;ORAL206855-001Nov 17, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Puracap Pharm LlcMEMANTINE HYDROCHLORIDEmemantine hydrochlorideTABLET;ORAL206855-002Nov 17, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ajanta Pharma LtdMEMANTINE HYDROCHLORIDEmemantine hydrochlorideTABLET;ORAL206528-002Nov 30, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncMEMANTINE HYDROCHLORIDEmemantine hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL206032-001Sep 28, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncMEMANTINE HYDROCHLORIDEmemantine hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL206032-002Sep 28, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Silarx Pharms IncMEMANTINE HYDROCHLORIDEmemantine hydrochlorideTABLET;ORAL207236-001Nov 10, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Forest Labs LlcNAMENDA XRmemantine hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022525-001Jun 21, 2010ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdMEMANTINE HYDROCHLORIDEmemantine hydrochlorideTABLET;ORAL090048-001Apr 14, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Forest Labs LlcNAMENDA XRmemantine hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022525-003Jun 21, 2010ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: memantine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs LlcNAMENDA XRmemantine hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022525-003Jun 21, 2010► Subscribe► Subscribe
Forest Labs LlcNAMENDAmemantine hydrochlorideSOLUTION;ORAL021627-001Apr 18, 2005► Subscribe► Subscribe
Forest Labs LlcNAMENDAmemantine hydrochlorideTABLET;ORAL021487-001Oct 16, 2003► Subscribe► Subscribe
Forest Labs LlcNAMENDAmemantine hydrochlorideSOLUTION;ORAL021627-001Apr 18, 2005► Subscribe► Subscribe
Forest Labs LlcNAMENDA XRmemantine hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022525-001Jun 21, 2010► Subscribe► Subscribe
Forest Labs LlcNAMENDAmemantine hydrochlorideTABLET;ORAL021487-001Oct 16, 2003► Subscribe► Subscribe
Forest Labs LlcNAMENDA XRmemantine hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022525-004Jun 21, 2010► Subscribe► Subscribe
Forest Labs LlcNAMENDA XRmemantine hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL022525-002Jun 21, 2010► Subscribe► Subscribe
Forest Labs LlcNAMENDAmemantine hydrochlorideTABLET;ORAL021487-002Oct 16, 2003► Subscribe► Subscribe
Forest Labs LlcNAMENDAmemantine hydrochlorideTABLET;ORAL021487-002Oct 16, 2003► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Chubb
Boehringer Ingelheim
Mallinckrodt
McKinsey
Covington
Cerilliant
Fuji
Daiichi Sankyo
Healthtrust
Johnson and Johnson

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 verifification 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.

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