FDA Orange Book · active-ingredient family
Betamethasone dipropionate
Betamethasone dipropionate: 15 brands, 45 generics; first approved Jul 27, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 45 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
15
Generics (ANDA)
45
Listed patents
7
Next patent expiry
Aug 31, 2030
in 4 yr 1 mo
Brand (NDA) products
Originator applications
- PRIMUS PHARMSNDA 2080792016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE/SPRAY SPRAY TOPICAL Rx — - DIPROLENERLDORGANONNDA 0197161988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION, AUGMENTED TOPICAL Discontinued — - DIPROLENE AFRLDORGANONNDA 0195551987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM, AUGMENTED TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATERLDRSFOUGERA PHARMS INCNDA 0191411984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT TOPICAL Rx AB - BETAMETHASONE DIPROPIONATERLDRSFOUGERA PHARMSNDA 0191371984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Rx AB - ORGANONNDA 0187411983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT, AUGMENTED TOPICAL Rx AB - DIPROSONERLDSCHERINGNDA 017781—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Discontinued — - SCHERINGNDA 01940819862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM, AUGMENTED TOPICAL Discontinued — EQ 0.05% BASE GEL, AUGMENTED TOPICAL Discontinued — - SAVAGE LABSNDA 0191431984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEPHARMADERMNDA 0191401984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT TOPICAL Discontinued — - SAVAGE LABSNDA 0191381984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEPHARMADERMNDA 0191361984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Discontinued — - SCHERINGNDA 017536—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Discontinued — - SCHERINGNDA 017829—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE DISC TOPICAL Discontinued — - SCHERINGNDA 017691—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT TOPICAL Discontinued —
Generic (ANDA) products (45)
Abbreviated applications
- BETAMETHASONE DIPROPIONATEAUROBINDO PHARMA LTDANDA 2193482026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEAUROBINDO PHARMA LTDANDA 2182892024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEPADAGIS ISRAELANDA 2158472022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT TOPICAL Rx AB - BETAMETHASONE DIPROPIONATETP ANDA HOLDINGSANDA 2151862022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEZYDUS LIFESCIENCESANDA 2140482020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT TOPICAL Rx AB - BETAMETHASONE DIPROPIONATESUN PHARMA CANADAANDA 2117222020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE/SPRAY SPRAY TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATELUPINANDA 2091062019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEHIKMAANDA 2088492019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION, AUGMENTED TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEZYDUS PHARMSANDA 2088852019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Rx AB - BETAMETHASONE DIPROPIONATECOSETTE PHARMS NCANDA 2102172018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEENCUBEANDA 2063892018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEHIKMAANDA 2098962018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEPADAGIS USANDA 2061182017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT, AUGMENTED TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEGLENMARK PHARMSANDA 0789302008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM, AUGMENTED TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEFOUGERA PHARMSANDA 0771112007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATERSSUN PHARMA CANADAANDA 0774772007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATESUN PHARMA CANADAANDA 0767532004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT, AUGMENTED TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATECHARTWELL MOLECULARANDA 0766032004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM, AUGMENTED TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEFOUGERA PHARMSANDA 0762152003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEPADAGIS ISRAELANDA 0765922003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATERSSUN PHARMA CANADAANDA 0765432003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATESUN PHARMA CANADAANDA 0765082003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE GEL, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATERSFOUGERA PHARMSANDA 0752762003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE GEL, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEFOUGERA PHARMSANDA 0753731999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEPERRIGO NEW YORKANDA 0745791997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEACTAVIS MID ATLANTICANDA 0743041995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT, AUGMENTED TOPICAL Rx AB - BETAMETHASONE DIPROPIONATESUN PHARMA CANADAANDA 0742721994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATESUN PHARMA CANADAANDA 0742711994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATESUN PHARMA CANADAANDA 0735521992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEPERRIGO NEW YORKANDA 0725361990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEPADAGIS USANDA 0725381990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEPERRIGO NEW YORKANDA 0725261990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATESUN PHARMA CANADAANDA 0722761988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATECOSETTE PHARMS NCANDA 0718821988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATETEVAANDA 0714761987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATECOSETTE PHARMS NCANDA 0714671987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Rx AB - BETAMETHASONE DIPROPIONATETEVAANDA 0714771987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATESUN PHARMA CANADAANDA 0711431987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEACTAVIS MID ATLANTICANDA 0708851987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE CREAM TOPICAL Rx AB - BETAMETHASONE DIPROPIONATEALPHARMA US PHARMSANDA 0710851987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEACTAVIS MID ATLANTICANDA 0710121987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE OINTMENT TOPICAL Rx AB - SAVAGE LABSANDA 0702731985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATERSFOUGERA PHARMS INCANDA 0702751985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Rx AB - BETAMETHASONE DIPROPIONATESHREE HARI INTLANDA 0702741985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Discontinued — - BETAMETHASONE DIPROPIONATEACTAVIS MID ATLANTICANDA 0702811985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05% BASE LOTION TOPICAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9775851 | in 4 yr 1 mo | ProductU-1858 | |
| 9364485 | in 4 yr 1 mo | ProductU-1858 | |
| 9655907 | in 4 yr 1 mo | ProductU-1858 | |
| 10179137 | in 4 yr 1 mo | ProductU-1858 | |
| 9433630 | in 4 yr 1 mo | ProductU-1858 | |
| 9877974 | in 4 yr 1 mo | ProductU-1858 | |
| 9439911 | in 4 yr 1 mo | ProductU-1858 |
Approval history
FDA approval span
First approval
43 yr 8 mo ago
Most recent approval
7 mo ago
Approvals span 1983–2026 across 60 FDA applications.
Brand (NDA) 1525%
Generic (ANDA) 4575%
Betamethasone dipropionate: 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.
