FDA Orange Book · active-ingredient family
Calcitriol
Calcitriol is approved as 4 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VECTICAL · NDA 022087
4
Brand (NDA)
19
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, injectable, ointment, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VECTICALRLD | GALDERMA LABS LP | NDA 022087 | — | Jan 23, 2009 | |
| ROCALTROLRLD | ESJAY PHARMA | NDA 021068 | AA | Nov 20, 1998 | |
| CALCIJEXRLD×2 | ABBVIE | NDA 018874 | — | Sep 25, 1986 | |
| ROCALTROLRLD×2 | ESJAY PHARMA | NDA 018044 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (19)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CALCITRIOL×2 | HUMANWELL PURACAP | ANDA 219796 | AB | Feb 27, 2026 | |
| CALCITRIOL | ANDA REPOSITORY | ANDA 203973 | AA | Jul 28, 2023 | |
| CALCITRIOL | GLAND | ANDA 211030 | AP | Feb 03, 2020 | |
| CALCITRIOL×2 | SUN PHARM | ANDA 204556 | — | Feb 21, 2019 | |
| CALCITRIOL | RISING | ANDA 209798 | AA | Nov 21, 2018 | |
| CALCITRIOL×2 | AMNEAL PHARMS | ANDA 203289 | AB | Jun 14, 2017 | |
| CALCITRIOL×2 | ONESOURCE SPECIALTY | ANDA 091356 | AB | Dec 12, 2014 | |
| CALCITRIOL×2 | BIONPHARMA | ANDA 091174 | AB | May 24, 2013 | |
| CALCITRIOL×2 | LONG GROVE PHARMS | ANDA 078066 | AP | Jan 29, 2008 | |
| CALCITRIOL | HIKMA | ANDA 076917 | AB | Mar 27, 2006 | |
| CALCITRIOL | SAGENT PHARMS | ANDA 077102 | — | Feb 08, 2006 | |
| CALCITRIOL×2 | HOSPIRA | ANDA 075816 | — | Jan 16, 2004 | |
| CALCITRIOL×2 | AM REGENT | ANDA 075746 | — | Sep 26, 2003 | |
| CALCITRIOL | ROCKWELL MEDCL | ANDA 076206 | — | Sep 17, 2003 | |
| CALCITRIOL | HIKMA | ANDA 076242 | AA | Jul 18, 2003 | |
| CALCITRIOL×2 | TEVA PARENTERAL | ANDA 075823 | — | Mar 31, 2003 | |
| CALCITRIOL×2 | FRESENIUS MEDCL | ANDA 075766 | — | Feb 20, 2003 | |
| CALCITRIOL×2 | FRESENIUS KABI USA | ANDA 075836 | — | Dec 31, 2002 | |
| CALCITRIOL×2 | TEVA | ANDA 075765 | AB | Oct 12, 2001 |
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.
Calcitriol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
