FDA Orange Book · active-ingredient family
Doxercalciferol
Doxercalciferol: 3 brands, 15 generics; first approved Jun 09, 1999; generic available.
Generic available3 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Latest exclusivity ends
Brands (NDA)
3
Generics (ANDA)
15
Listed patents
0
Presentations
33
Brand (NDA) products
Originator applications
- DOXERCALCIFEROLRLDHOSPIRANDA 20861420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Discontinued — 10MCG/5ML (2MCG/ML) INJECTABLE INJECTION Discontinued — - HECTOROLRLDSANOFINDA 02086220043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MCG CAPSULE ORAL Discontinued — 0.5MCG CAPSULE ORAL Discontinued — 1MCG CAPSULE ORAL Discontinued — - HECTOROLRLDSANOFINDA 02102720002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Discontinued — 2MCG/ML (2MCG/ML) INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (15)
Abbreviated applications
- DOXERCALCIFEROLALEMBICANDA 2158102023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Rx AP - DOXERCALCIFEROLEUGIA PHARMAANDA 21371720222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MCG/ML (2MCG/ML) INJECTABLE INJECTION Discontinued — 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Discontinued — - DOXERCALCIFEROLAVETANDA 20536020203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MCG CAPSULE ORAL Rx AB 1MCG CAPSULE ORAL Rx AB 2.5MCG CAPSULE ORAL Rx AB - DOXERCALCIFEROLRSMEITHEALANDA 2116702020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Rx AP - DOXERCALCIFEROLSUN PHARMANDA 20387520192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MCG/ML (2MCG/ML) INJECTABLE INJECTION Discontinued — 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Discontinued — - DOXERCALCIFEROLGLANDANDA 2104522019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Rx AP - DOXERCALCIFEROLLUPINANDA 2108012018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Discontinued — - DOXERCALCIFEROLAMNEALANDA 20897420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MCG/ML (2MCG/ML) INJECTABLE INJECTION Discontinued — 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Discontinued — - DOXERCALCIFEROLAMNEALANDA 2089752017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Discontinued — - DOXERCALCIFEROLRISINGANDA 20151820163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MCG CAPSULE ORAL Rx AB 1MCG CAPSULE ORAL Rx AB 2.5MCG CAPSULE ORAL Rx AB - DOXERCALCIFEROLEPIC PHARMA LLCANDA 20392920162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Discontinued — 2MCG/ML (2MCG/ML) INJECTABLE INJECTION Discontinued — - DOXERCALCIFEROLSANDOZANDA 0913332014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Rx AP - DOXERCALCIFEROLCAPLINANDA 20092620142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Discontinued — 2MCG/ML (2MCG/ML) INJECTABLE INJECTION Discontinued — - DOXERCALCIFEROLHIKMAANDA 0911012013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MCG/2ML (2MCG/ML) INJECTABLE INJECTION Discontinued — - DOXERCALCIFEROLHIKMAANDA 09143320113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MCG CAPSULE ORAL Discontinued — 1MCG CAPSULE ORAL Discontinued — 2.5MCG CAPSULE ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- M-14New use / labeling-change exclusivity (3 years)
in 1 yr 10 mo
- M-14New use / labeling-change exclusivity (3 years)
in 1 yr 10 mo
- M-14New use / labeling-change exclusivity (3 years)
in 1 yr 10 mo
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
27 yr 7 mo ago
Most recent approval
3 yr 3 mo ago
Approvals span 1999–2023 across 18 FDA applications.
Brand (NDA) 317%
Generic (ANDA) 1583%
Doxercalciferol: 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.
