FDA Orange Book · active-ingredient family
Memantine hydrochloride
Memantine hydrochloride: 3 brands, 43 generics; first approved Oct 16, 2003; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 43 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
43
Listed patents
2
Next patent expiry
Mar 24, 2029
in 2 yr 6 mo
Brand (NDA) products
Originator applications
- NAMENDA XRRLDABBVIENDA 02252520104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 14MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 21MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 28MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - NAMENDARLDALLERGANNDA 0216272005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML SOLUTION ORAL Discontinued — - NAMENDARLDABBVIENDA 02148720032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued —
Generic (ANDA) products (43)
Abbreviated applications
- MEMANTINE HYDROCHLORIDEMACLEODS PHARMSANDA 20631020254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 21MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MEMANTINE HYDROCHLORIDEH2-PHARMAANDA 21398520224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 21MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MEMANTINE HYDROCHLORIDEHETERO LABS LTD VANDA 20438920222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 21465120214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 21MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MEMANTINE HYDROCHLORIDEYICHANG HUMANWELLANDA 21110020214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 21MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MEMANTINE HYDROCHLORIDEPURACAP LABS BLUANDA 21058720202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDEMEDLEY PHARMSANDA 2103192020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML SOLUTION ORAL Rx AA - MEMANTINE HYDROCHLORIDEYILINGANDA 21294720202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDEANI PHARMSANDA 20536520204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 14MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 21MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 28MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - MEMANTINE HYDROCHLORIDEHIKMAANDA 20817320202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - MEMANTINE HYDROCHLORIDECHARTWELLANDA 09024420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - MEMANTINE HYDROCHLORIDERENATAANDA 20952720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDEAPOTEXANDA 2099552018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML SOLUTION ORAL Rx AA - MEMANTINE HYDROCHLORIDEZYDUS PHARMSANDA 20329320174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 21MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MEMANTINE HYDROCHLORIDEZYDUS LIFESCIENCESANDA 09096120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDEPH HEALTHANDA 20578420174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 14MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 21MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 28MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - MEMANTINE HYDROCHLORIDESTRIDES PHARMAANDA 20235020172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - MEMANTINE HYDROCHLORIDEAPOTEXANDA 20613520164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 14MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 21MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 28MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - MEMANTINE HYDROCHLORIDELANNETT CO INCANDA 20723620162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - MEMANTINE HYDROCHLORIDEAMNEAL PHARMSANDA 20582520164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 21MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MEMANTINE HYDROCHLORIDELUPINANDA 20602820164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 21MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MEMANTINE HYDROCHLORIDERISINGANDA 20603220164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 21MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MEMANTINE HYDROCHLORIDESUN PHARMANDA 20590520164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 14MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 21MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — 28MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - MEMANTINE HYDROCHLORIDEAPOZEAL PHARMSANDA 2054462015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML SOLUTION ORAL Discontinued — - MEMANTINE HYDROCHLORIDEAJANTA PHARMA LTDANDA 20652820152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDEPURACAP PHARM LLCANDA 20685520152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDERSCHARTWELL MOLECULARANDA 2040332015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML SOLUTION ORAL Rx AA - MEMANTINE HYDROCHLORIDEMACLEODS PHARMSANDA 2027902015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML SOLUTION ORAL Rx AA - MEMANTINE HYDROCHLORIDEALEMBICANDA 20089120152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 20317520152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDEJUBILANT GENERICSANDA 09158520152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - MEMANTINE HYDROCHLORIDEMACLEODS PHARMS LTDANDA 20284020152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDETORRENTANDA 20015520152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - MEMANTINE HYDROCHLORIDEUNICHEMANDA 20002220152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDEPOINTVIEW HLDINGSANDA 09007320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - MEMANTINE HYDROCHLORIDEUPSHER SMITH LABSANDA 09004320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDEAMNEAL PHARMSANDA 09004120152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDELUPINANDA 09005120152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDERISINGANDA 07922520152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - MEMANTINE HYDROCHLORIDEORBION PHARMSANDA 09004420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - MEMANTINE HYDROCHLORIDETEVA PHARMSANDA 09005220112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - MEMANTINE HYDROCHLORIDESUN PHARMANDA 09005820102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - MEMANTINE HYDROCHLORIDEDR REDDYS LABS LTDANDA 09004820102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8039009 | in 2 yr 6 mo | U-539 | |
| 8039009*PED | in 3 yr |
Approval history
FDA approval span
First approval
23 yr 4 mo ago
Most recent approval
1 yr 2 mo ago
Approvals span 2003–2025 across 46 FDA applications.
Brand (NDA) 37%
Generic (ANDA) 4393%
Memantine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
