FDA Orange Book · active-ingredient family
Caspofungin acetate
Caspofungin acetate: 2 brands, 7 generics; first approved Jan 26, 2001; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
7
Listed patents
1
Next patent expiry
Dec 21, 2032
in 6 yr 5 mo
Brand (NDA) products
Originator applications
- CANCIDASRLDMERCKNDA 02122720012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Discontinued — 70MG/VIAL POWDER INTRAVENOUS Discontinued — - CASPOFUNGIN ACETATEFRESENIUS KABI USANDA 20611020162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Rx AP 70MG/VIAL POWDER INTRAVENOUS Rx AP
Generic (ANDA) products (7)
Abbreviated applications
- CASPOFUNGIN ACETATEHANGZHOU ZHONGMEIANDA 21650620252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Rx AP 70MG/VIAL POWDER INTRAVENOUS Rx AP - CASPOFUNGIN ACETATEAREVA PHARMSANDA 21126320212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Rx AP 70MG/VIAL POWDER INTRAVENOUS Rx AP - CASPOFUNGIN ACETATECIPLAANDA 20948920182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Discontinued — 70MG/VIAL POWDER INTRAVENOUS Discontinued — - CASPOFUNGIN ACETATEXELLIA PHARMS APSANDA 20592320182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Discontinued — 70MG/VIAL POWDER INTRAVENOUS Discontinued — - CASPOFUNGIN ACETATEHENGRUI PHARMAANDA 20083320182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Discontinued — 70MG/VIAL POWDER INTRAVENOUS Discontinued — - CASPOFUNGIN ACETATERSGLANDANDA 20709220172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Rx AP 70MG/VIAL POWDER INTRAVENOUS Rx AP - CASPOFUNGIN ACETATEPHARMOBEDIENTANDA 20765020172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Discontinued — 70MG/VIAL POWDER INTRAVENOUS Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9636407 | in 6 yr 5 mo | Product |
Approval history
FDA approval span
First approval
25 yr 11 mo ago
Most recent approval
1 yr 1 mo ago
Approvals span 2001–2025 across 9 FDA applications.
Brand (NDA) 222%
Generic (ANDA) 778%
Caspofungin acetate: 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.
