FDA Orange Book · active-ingredient family
Doxercalciferol
Doxercalciferol is approved as 3 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DOXERCALCIFEROL · NDA 208614
3
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
3
Exclusivity periods
Brand (NDA) products · capsule, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOXERCALCIFEROLRLD×2 | HOSPIRA | NDA 208614 | — | Jul 24, 2018 | |
| HECTOROLRLD×3 | SANOFI | NDA 020862 | — | Apr 23, 2004 | |
| HECTOROLRLD×2 | SANOFI | NDA 021027 | — | Apr 06, 2000 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOXERCALCIFEROL | ALEMBIC | ANDA 215810 | AP | Jun 15, 2023 | |
| DOXERCALCIFEROL×2 | EUGIA PHARMA | ANDA 213717 | — | Jan 24, 2022 | |
| DOXERCALCIFEROL×3 | AVET | ANDA 205360 | AB | Sep 15, 2020 | |
| DOXERCALCIFEROL | MEITHEAL | ANDA 211670 | AP | Feb 07, 2020 | |
| DOXERCALCIFEROL×2 | SUN PHARM | ANDA 203875 | — | Nov 14, 2019 | |
| DOXERCALCIFEROL | GLAND | ANDA 210452 | AP | Sep 26, 2019 | |
| DOXERCALCIFEROL | LUPIN | ANDA 210801 | — | Nov 01, 2018 | |
| DOXERCALCIFEROL×2 | AMNEAL | ANDA 208974 | — | May 24, 2017 | |
| DOXERCALCIFEROL | AMNEAL | ANDA 208975 | — | May 24, 2017 | |
| DOXERCALCIFEROL×3 | RISING | ANDA 201518 | AB | Sep 09, 2016 | |
| DOXERCALCIFEROL×2 | EPIC PHARMA LLC | ANDA 203929 | — | Mar 28, 2016 | |
| DOXERCALCIFEROL | SANDOZ | ANDA 091333 | AP | May 05, 2014 | |
| DOXERCALCIFEROL×2 | CAPLIN | ANDA 200926 | — | Feb 04, 2014 | |
| DOXERCALCIFEROL | HIKMA | ANDA 091101 | — | Aug 30, 2013 | |
| DOXERCALCIFEROL×3 | HIKMA | ANDA 091433 | — | Sep 23, 2011 |
Marketing exclusivity (3)
- M-14New use / labeling-change exclusivity (3 years)
Jun 11, 2028
in 2 yr
- M-14New use / labeling-change exclusivity (3 years)
Jun 11, 2028
in 2 yr
- M-14New use / labeling-change exclusivity (3 years)
Jun 11, 2028
in 2 yr
Listed patents
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.
Doxercalciferol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
