FDA Orange Book · active-ingredient family
Benzoyl peroxide; clindamycin phosphate
Benzoyl peroxide; clindamycin phosphate: 3 brands, 17 generics; first approved Dec 21, 2000; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 17 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
17
Listed patents
9
Next patent expiry
Jun 03, 2029
in 2 yr 9 mo
Brand (NDA) products
Originator applications
- BAUSCHNDA 05081920082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5%;EQ 1.2% BASE GEL TOPICAL Rx AB 3.75%;EQ 1.2% BASE GEL TOPICAL Rx AB - DUACRLDSTIEFELNDA 0507412002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;1.2% GEL TOPICAL Rx AB - BENZACLINRLDBAUSCHNDA 05075620002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;EQ 1% BASE GEL TOPICAL Discontinued — 5%;EQ 1% BASE GEL TOPICAL Discontinued —
Generic (ANDA) products (17)
Abbreviated applications
- ACTAVIS LABS UT INCANDA 2087572026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75%;EQ 1.2% BASE GEL TOPICAL Rx AB - PADAGIS ISRAELANDA 2096102024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75%;EQ 1.2% BASE GEL TOPICAL Rx AB - ENCUBEANDA 2124332021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;1.2% GEL TOPICAL Rx AB - PADAGIS ISRAELANDA 2053972019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5%;EQ 1.2% BASE GEL TOPICAL Rx AB - ENCUBEANDA 2071942019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5%;EQ 1.2% BASE GEL TOPICAL Rx AB - SUN PHARMA CANADAANDA 2065752019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5%;EQ 1.2% BASE GEL TOPICAL Rx AB - GLENMARK SPECLTANDA 2092522019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;EQ 1% BASE GEL TOPICAL Rx AB - ZYDUS PHARMSANDA 2107942018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;1.2% GEL TOPICAL Rx AB - SUN PHARMA CANADAANDA 2086832018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75%;EQ 1.2% BASE GEL TOPICAL Rx AB - SUN PHARMA CANADAANDA 2087762018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;EQ 1% BASE GEL TOPICAL Rx AB - SUN PHARMA CANADAANDA 2062182017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;1.2% GEL TOPICAL Rx AB - ENCUBEANDA 2040872017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;EQ 1% BASE GEL TOPICAL Rx AB - CHARTWELL RXANDA 2036882016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;1.2% GEL TOPICAL Discontinued — - PADAGIS ISRAELANDA 2024402015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;EQ 1% BASE GEL TOPICAL Rx AB - ACTAVIS LABS UT INCANDA 2051282015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5%;EQ 1.2% BASE GEL TOPICAL Discontinued — - PADAGIS ISRAELANDA 0909792012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;1.2% GEL TOPICAL Rx AB - MYLAN PHARMS INCANDA 0654432009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5%;EQ 1% BASE GEL TOPICAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8895070 | in 2 yr 9 mo | U-124 | |
| 10220049 | in 2 yr 9 mo | ProductU-916 | |
| 10624918 | in 2 yr 9 mo | U-916 | |
| 8663699 | in 2 yr 9 mo | U-124 | |
| 9078870 | in 2 yr 9 mo | Product | |
| 9561208 | in 2 yr 9 mo | ProductU-916 | |
| 9504704 | in 2 yr 9 mo | ProductU-134 | |
| 10137142 | in 2 yr 9 mo | ProductU-916 | |
| 8288434 | in 2 yr 11 mo | ProductU-124 |
Approval history
FDA approval span
First approval
26 yr 1 mo ago
Most recent approval
1 mo ago
Approvals span 2000–2026 across 20 FDA applications.
Brand (NDA) 315%
Generic (ANDA) 1785%
Benzoyl peroxide; 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
- 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.
