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FDA Orange Book · active-ingredient family

Maraviroc

Maraviroc: 2 brands, 4 generics; first approved Aug 06, 2007; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 4 ANDA applications approved.

Brands (NDA)
2
Generics (ANDA)
4
Listed patents
0
Presentations
13

Brand (NDA) products

Originator applications
  • NDA 2089842016
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    20MG/MLSOLUTIONORALRx—
  • NDA 02212820164 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    150MGTABLETORALRxAB
    300MGTABLETORALRxAB
    25MGTABLETORALDiscontinued—
    75MGTABLETORALDiscontinued—

Generic (ANDA) products (4)

Abbreviated applications
  • MARAVIROC
    ANDA 21614320252 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    150MGTABLETORALDiscontinued—
    300MGTABLETORALDiscontinued—
  • MARAVIROC
    ANDA 21788020252 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    150MGTABLETORALRxAB
    300MGTABLETORALRxAB
  • MARAVIROC
    ANDA 21711420232 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    150MGTABLETORALRxAB
    300MGTABLETORALRxAB
  • MARAVIROC
    ANDA 20334720222 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    150MGTABLETORALRxAB
    300MGTABLETORALRxAB

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span
First approval
19 yr 6 mo ago
Most recent approval
11 mo ago

Approvals span 2007–2025 across 6 FDA applications.

Brand (NDA) 233%
Generic (ANDA) 467%

Maraviroc: 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.

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