FDA Orange Book · active-ingredient family
Hydroxyprogesterone caproate
Hydroxyprogesterone caproate: 4 brands, 2 generics; first approved Aug 24, 2015; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
2
Listed patents
0
Presentations
9
Brand (NDA) products
Originator applications
- DELALUTINRLDBRISTOL MYERS SQUIBBNDA 010347—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/ML (250MG/ML) SOLUTION INTRAMUSCULAR Discontinued — 125MG/ML (125MG/ML) SOLUTION INTRAMUSCULAR Discontinued — - DELALUTINRLDBRISTOL MYERS SQUIBBNDA 016911—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/ML (125MG/ML) SOLUTION INTRAMUSCULAR Discontinued — 250MG/ML (250MG/ML) SOLUTION INTRAMUSCULAR Discontinued — - HYDROXYPROGESTERONE CAPROATEALLERGANNDA 017439—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/ML INJECTABLE INJECTION Discontinued — 250MG/ML INJECTABLE INJECTION Discontinued — - HYDROXYPROGESTERONE CAPROATEEPIC PHARMA LLCNDA 018004—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (2)
Abbreviated applications
- HYDROXYPROGESTERONE CAPROATEEUGIA PHARMAANDA 2111422019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1250MG/5ML (250MG/ML) SOLUTION INTRAMUSCULAR Discontinued — - HYDROXYPROGESTERONE CAPROATEASPEN GLOBAL INCANDA 2002712015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1250MG/5ML (250MG/ML) SOLUTION INTRAMUSCULAR Discontinued —
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
11 yr 3 mo ago
Most recent approval
7 yr 6 mo ago
Approvals span 2015–2019 across 6 FDA applications.
Brand (NDA) 467%
Generic (ANDA) 233%
Hydroxyprogesterone caproate: 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.
