FDA Orange Book · active-ingredient family
Amantadine hydrochloride
Amantadine hydrochloride: 5 brands, 37 generics; first approved Aug 05, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 37 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
5
Generics (ANDA)
37
Listed patents
21
Next patent expiry
Jan 22, 2028
in 1 yr 5 mo
Brand (NDA) products
Originator applications
- OSMOLEX ERRLDSUPERNUS PHARMSNDA 20941020184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 129MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 193MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 258MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 161MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - GOCOVRIRLDSUPERNUS PHARMSNDA 20894420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 68.5MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx — EQ 137MG BASE CAPSULE, EXTENDED RELEASE ORAL Rx — - SYMMETRELRLDENDO PHARMSNDA 016020—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - SYMMETRELRLDENDO PHARMSNDA 016023—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Discontinued — - SYMMETRELRLDENDO PHARMSNDA 018101—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued —
Generic (ANDA) products (37)
Abbreviated applications
- AMANTADINE HYDROCHLORIDEZHEJIANG JUTAI PHARMANDA 2185982024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - AMANTADINE HYDROCHLORIDEZYDUSANDA 2148972024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 68.5MG BASE CAPSULE, EXTENDED RELEASE ORAL Discontinued — - AMANTADINE HYDROCHLORIDEHUMANWELL PURACAPANDA 2145802022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - AMANTADINE HYDROCHLORIDEADAPTISANDA 2124072022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMANTADINE HYDROCHLORIDEONESOURCE SPECIALTYANDA 2113542022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - AMANTADINE HYDROCHLORIDEPOM PHARMAANDA 2141782021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Rx AA - AMANTADINE HYDROCHLORIDEALEMBICANDA 2142842020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - AMANTADINE HYDROCHLORIDERUBICON RESEARCHANDA 2120442020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - AMANTADINE HYDROCHLORIDEPOM PHARMAANDA 2102152020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - AMANTADINE HYDROCHLORIDERISINGANDA 2101292020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - AMANTADINE HYDROCHLORIDEJUBILANT GENERICSANDA 2104032018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMANTADINE HYDROCHLORIDEALEMBICANDA 2089662017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - AMANTADINE HYDROCHLORIDECHARTWELL MOLECULARANDA 2092212017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - AMANTADINE HYDROCHLORIDEHERITAGE PHARMAANDA 2091712017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - AMANTADINE HYDROCHLORIDESTRIDES PHARMAANDA 2090352017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - AMANTADINE HYDROCHLORIDESTRIDES PHARMAANDA 2090472017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - AMANTADINE HYDROCHLORIDEINVAGEN PHARMSANDA 2075712017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMANTADINE HYDROCHLORIDEWATSON LABS INCANDA 2080962016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - AMANTADINE HYDROCHLORIDEWATSON LABS INCANDA 2081072016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - AMANTADINE HYDROCHLORIDEINVAGEN PHARMSANDA 2075702016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - AMANTADINE HYDROCHLORIDEZYDUS PHARMSANDA 2082782016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - AMANTADINE HYDROCHLORIDERSBIONPHARMAANDA 0787202008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - AMANTADINE HYDROCHLORIDEPH HEALTHANDA 0779922006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Discontinued — - AMANTADINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 0776592006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - AMANTADINE HYDROCHLORIDECHARTWELL RXANDA 0763522004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Discontinued — - AMANTADINE HYDROCHLORIDERSUPSHER SMITH LABSANDA 0761862002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - AMANTADINE HYDROCHLORIDEADAPTISANDA 0758192002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Discontinued — - AMANTADINE HYDROCHLORIDEPHARMOBEDIENTANDA 0750601998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Rx AA - AMANTADINE HYDROCHLORIDERSPHARM ASSOCANDA 0745091995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Rx AA - AMANTADINE HYDROCHLORIDERSAUROBINDO PHARMA USAANDA 0741701994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Rx AA - AMANTADINE HYDROCHLORIDERSCHARTWELL RXANDA 0740281993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Rx AA - AMANTADINE HYDROCHLORIDETEVA PHARMSANDA 0731151991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Discontinued — - AMANTADINE HYDROCHLORIDEG AND W LABS INCANDA 0726551990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Discontinued — - AMANTADINE HYDROCHLORIDESANDOZANDA 0712931987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - AMANTADINE HYDROCHLORIDEWATSON LABSANDA 0713821987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - SOLVAYANDA 0710001986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - AMANTADINE HYDROCHLORIDEUPSHER SMITH LABSANDA 0705891986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8389578 | in 1 yr 5 mo | U-2105 | |
| 8252331 | in 3 yr 7 mo | Product | |
| 9867792 | in 4 yr 4 mo | U-2106 | |
| 9867791 | in 4 yr 4 mo | U-2106 | |
| 9877933 | in 4 yr 4 mo | U-2224 | |
| 8741343 | in 4 yr 4 mo | U-2106 | |
| 9867793 | in 4 yr 4 mo | U-2106 | |
| 11197835 | in 4 yr 4 mo | U-2106 | |
| 10646456 | in 7 yr 11 mo | U-2808 | |
| 11903908 | in 7 yr 11 mo | U-3822 | |
| 10154971 | in 8 yr 5 mo | U-2459 | |
| 10213393 | in 11 yr 8 mo | U-20 | |
| 10213394 | in 11 yr 8 mo | U-2497 | |
| 10500171 | in 11 yr 8 mo | U-2497 | |
| 10500172 | in 11 yr 8 mo | U-2497 | |
| 10500170 | in 11 yr 8 mo | U-20 | |
| 10512617 | in 11 yr 8 mo | U-2497 | |
| 11890261 | in 11 yr 8 mo | U-2497 | |
| 12233033 | in 12 yr 2 mo | U-2106 | |
| 11077073 | in 12 yr 2 mo | U-2106 | |
| 11065213 | in 12 yr 2 mo | Product |
Approval history
FDA approval span
First approval
40 yr 7 mo ago
Most recent approval
1 yr 11 mo ago
Approvals span 1986–2024 across 42 FDA applications.
Brand (NDA) 512%
Generic (ANDA) 3788%
Amantadine 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.
