FDA Orange Book · active-ingredient family
Estrone
Estrone: 1 brand, 4 generics; first approved Nov 23, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
4
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- PARKEDALENDA 003977—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — 2MG/ML INJECTABLE INJECTION Discontinued — 5MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (4)
Abbreviated applications
- WATSON LABSANDA 0852371982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - WYETH AYERSTANDA 083488—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - ESTRONEDR REDDYSANDA 085239—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML INJECTABLE INJECTION Discontinued — - ESTRONEWATSON LABSANDA 083397—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION 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
44 yr 4 mo ago
Most recent approval
44 yr 4 mo ago
All 5 applications were approved in 1982.
Brand (NDA) 120%
Generic (ANDA) 480%
Estrone: 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.
