Skip to content
Assyro AI
FDA Orange Book · active-ingredient family

Clindamycin phosphate

Clindamycin phosphate: 15 brands, 74 generics; first approved Feb 08, 1982; generic available.

Generic available2 exclusivity periodsHas discontinued products
Generic status & protection

Generic available: 74 ANDA applications approved.

Earliest patent expiry Latest exclusivity ends
Brands (NDA)
15
Generics (ANDA)
74
Listed patents
3
Next patent expiry
Dec 02, 2026
in 3 mo

Brand (NDA) products

Originator applications
  • XACIATORLDRS
    NDA 2156502021
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 2% BASEGELVAGINALRx
  • NDA 20808320173 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 300MG BASE/50ML (EQ 6MG BASE/ML)SOLUTIONINTRAVENOUSRx
    EQ 600MG BASE/50ML (EQ 12MG BASE/ML)SOLUTIONINTRAVENOUSRx
    EQ 900MG BASE/50ML (EQ 18MG BASE/ML)SOLUTIONINTRAVENOUSRx
  • NDA 0507932004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 2% BASECREAMVAGINALRx
  • NDA 0508012004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1%AEROSOL, FOAMTOPICALDiscontinued
  • NDA 0507822000
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB2
  • CLEOCINRLDRS
    NDA 0507671999
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    100MGSUPPOSITORYVAGINALRx
  • CLEOCINRLDRS
    NDA 05068019982 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 2% BASECREAMVAGINALDiscontinued
    EQ 2% BASECREAMVAGINALRxAB
  • NDA 0506351989
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 900MG BASE/100MLINJECTABLEINJECTIONRx
  • Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/MLINJECTABLEINJECTIONDiscontinued
    EQ 12MG BASE/MLINJECTABLEINJECTIONDiscontinued
    EQ 18MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • NDA 0506001989
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASELOTIONTOPICALRxAB
  • NDA 0506151987
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB1
  • NDA 050441
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONRxAP
  • NDA 0505372 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALDiscontinued
    EQ 1% BASESWABTOPICALDiscontinued
  • NDA 05064819893 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/MLINJECTABLEINJECTIONDiscontinued
    EQ 12MG BASE/MLINJECTABLEINJECTIONDiscontinued
    EQ 900MG BASE/100MLINJECTABLEINJECTIONDiscontinued
  • NDA 0506361989
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 12MG BASE/MLINJECTABLEINJECTIONDiscontinued

Generic (ANDA) products (74)

Abbreviated applications
  • CLINDAMYCIN PHOSPHATE
    ANDA 2183002026
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALRxAT
  • CLINDAMYCIN PHOSPHATE
    ANDA 2189422026
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB1
  • CLINDAMYCIN PHOSPHATE
    ANDA 2196122025
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESWABTOPICALRxAT
  • CLINDAMYCIN PHOSPHATE
    ANDA 2124662024
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB1
  • CLINDAMYCIN PHOSPHATE
    ANDA 2165872023
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB1
  • ANDA 21440120233 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/MLINJECTABLEINJECTIONRxAP
    EQ 12MG BASE/MLINJECTABLEINJECTIONRxAP
    EQ 18MG BASE/MLINJECTABLEINJECTIONRxAP
  • CLINDAMYCIN PHOSPHATE
    ANDA 2152192022
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 2146682022
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB2
  • CLINDAMYCIN PHOSPHATE
    ANDA 2156072022
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASELOTIONTOPICALRxAB
  • CLINDAMYCIN PHOSPHATE
    ANDA 2107782021
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1%AEROSOL, FOAMTOPICALRxAT
  • CLINDAMYCIN PHOSPHATE
    ANDA 2128422021
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB2
  • CLINDAMYCIN PHOSPHATE
    ANDA 2145262021
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASELOTIONTOPICALRxAB
  • CLINDAMYCIN PHOSPHATE
    ANDA 2124382021
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB1
  • CLINDAMYCIN PHOSPHATE
    ANDA 2146042021
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASELOTIONTOPICALRxAB
  • CLINDAMYCIN PHOSPHATE
    ANDA 2142512021
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB1
  • CLINDAMYCIN PHOSPHATE
    ANDA 2121042020
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB1
  • CLINDAMYCIN PHOSPHATE
    ANDA 2140522020
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB1
  • CLINDAMYCIN PHOSPHATE
    ANDA 2118722020
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB1
  • CLINDAMYCIN PHOSPHATE
    ANDA 2100042020
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1%AEROSOL, FOAMTOPICALRxAT
  • CLINDAMYCIN PHOSPHATE
    ANDA 2099142019
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALRxAT
  • CLINDAMYCIN PHOSPHATE
    ANDA 2087672018
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALRxAT
  • CLINDAMYCIN PHOSPHATE
    ANDA 2098462018
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALRxAT
  • CLINDAMYCIN PHOSPHATE
    ANDA 2047482017
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 2047492017
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • ANDA 20808420173 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/MLINJECTABLEINJECTIONRxAP
    EQ 12MG BASE/MLINJECTABLEINJECTIONRxAP
    EQ 18MG BASE/MLINJECTABLEINJECTIONRxAP
  • CLINDAMYCIN PHOSPHATE
    ANDA 2069452016
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 2033432015
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALDiscontinued
  • Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/MLINJECTABLEINJECTIONRxAP
    EQ 12MG BASE/MLINJECTABLEINJECTIONRxAP
    EQ 18MG BASE/MLINJECTABLEINJECTIONRxAP
  • ANDA 20169220123 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/MLINJECTABLEINJECTIONRxAP
    EQ 12MG BASE/MLINJECTABLEINJECTIONRxAP
    EQ 18MG BASE/MLINJECTABLEINJECTIONRxAP
  • CLINDAMYCIN PHOSPHATE
    ANDA 0901082011
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONRxAP
  • CLINDAMYCIN PHOSPHATE
    ANDA 0901092011
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONRxAP
  • CLINDAMYCIN PHOSPHATE
    ANDA 0655132010
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESWABTOPICALRxAT
  • CLINDAMYCIN PHOSPHATERS
    ANDA 0907852010
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1%AEROSOL, FOAMTOPICALRxAT
  • CLINDAMYCIN PHOSPHATE
    ANDA 0653472007
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0653462007
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0652542006
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0651392004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 2% BASECREAMVAGINALRxAB
  • CLINDAMYCIN PHOSPHATE
    ANDA 0652062004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONRxAP
  • CLINDAMYCIN PHOSPHATE
    ANDA 0651842004
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALRxAT
  • CLINDAMYCIN PHOSPHATE
    ANDA 0650672002
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASELOTIONTOPICALRxAB
  • Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/MLINJECTABLEINJECTIONDiscontinued
    EQ 12MG BASE/MLINJECTABLEINJECTIONDiscontinued
    EQ 18MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATERS
    ANDA 0650492000
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESWABTOPICALRxAT
  • CLINDAMYCIN PHOSPHATE
    ANDA 0641602000
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASEGELTOPICALRxAB1
  • CLINDAMYCIN PHOSPHATE
    ANDA 0633041997
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0641591997
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALRxAT
  • ANDA 0641361996
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESWABTOPICALDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0641081996
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALDiscontinued
  • CLINDAMYCIN PHOSPHATERS
    ANDA 0640501995
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALRxAT
  • CLINDAMYCIN PHOSPHATE
    ANDA 0631631994
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • ANDA 0633291992
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0632821992
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0630791990
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0630411989
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0630681989
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0629301989
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0629281989
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0629081989
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0629441989
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0629131988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0629431988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0628111988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0629001988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0627471988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0629051988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0628891988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONRxAP
  • CLINDAMYCIN PHOSPHATE
    ANDA 0629531988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0628521988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0628191988
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • ANDA 0628031987
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONRxAP
  • CLINDAMYCIN PHOSPHATE
    ANDA 0628061987
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0628001987
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • CLINDAMYCIN PHOSPHATE
    ANDA 0628011987
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued
  • ANDA 0623631982
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 1% BASESOLUTIONTOPICALDiscontinued
  • ANDA 061839
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 150MG BASE/MLINJECTABLEINJECTIONDiscontinued

Patent & exclusivity timeline

Protection horizon
2024202620282030203220342036TodayExclusivity NP: 2024-12-07Exclusivity NPPatent 9789057: 2026-12-02Patent 9789057Exclusivity GAIN: 2029-12-07Exclusivity GAINPatent 11129896: 2036-09-22Patent 11129896Patent 12303563: 2036-09-22Patent 12303563
Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman
  • NPNew product exclusivity (3 years)

    1 yr 9 mo ago

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    in 3 yr 4 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9789057in 3 mo
ProductU-137
11129896in 10 yr 3 mo
U-3293
12303563in 10 yr 3 mo
Product

Approval history

FDA approval span
First approval
45 yr 2 mo ago
Most recent approval
5 mo ago

Approvals span 1982–2026 across 89 FDA applications.

Brand (NDA) 1517%
Generic (ANDA) 7483%

Clindamycin phosphate: 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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.