FDA Orange Book · active-ingredient family
Estradiol valerate
Estradiol valerate: 1 brand, 7 generics; first approved Oct 04, 2007; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
17
Brand (NDA) products
Originator applications
- PH HEALTHNDA 009402—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AO 40MG/ML INJECTABLE INJECTION Discontinued — 20MG/ML INJECTABLE INJECTION Rx AO
Generic (ANDA) products (7)
Abbreviated applications
- ESTRADIOL VALERATEXIROMEDANDA 21665620233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AO 20MG/ML INJECTABLE INJECTION Rx AO 40MG/ML INJECTABLE INJECTION Rx AO - ESTRADIOL VALERATEHIKMAANDA 20372320203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AO 20MG/ML INJECTABLE INJECTION Rx AO 40MG/ML INJECTABLE INJECTION Rx AO - ESTRADIOL VALERATEAM REGENTANDA 09092020102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AO 40MG/ML INJECTABLE INJECTION Rx AO - ESTRADIOL VALERATEFOSUN PHARMAANDA 04062820073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — 20MG/ML INJECTABLE INJECTION Discontinued — 40MG/ML INJECTABLE INJECTION Discontinued — - ESTRADIOL VALERATEDR REDDYSANDA 083547—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - ESTRADIOL VALERATEDR REDDYSANDA 083714—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - ESTRADIOL VALERATEWATSON LABSANDA 083546—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/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
19 yr 2 mo ago
Most recent approval
3 yr 5 mo ago
Approvals span 2007–2023 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Estradiol valerate: 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.
