Calcitriol (Rocaltrol®) — Competitive Intelligence Brief

Calcitriol (Rocaltrol®) (Calcitriol (Rocaltrol®)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Vitamin D analog. Area: Endocrinology.

marketed Vitamin D analog Vitamin D receptor (VDR) Endocrinology Small molecule

Target snapshot

Calcitriol (Rocaltrol®) (Calcitriol (Rocaltrol®)) — Joslin Diabetes Center. Calcitriol is the active form of vitamin D that binds to vitamin D receptors to regulate calcium and phosphate homeostasis and promote bone mineralization.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Calcitriol (Rocaltrol®) TARGET	Calcitriol (Rocaltrol®)	Joslin Diabetes Center	marketed	Vitamin D analog	Vitamin D receptor (VDR)
Dovonex	CALCIPOTRIENE		marketed	Vitamin D Analog [EPC]	Vitamin D3 receptor	1993-01-01
intralesional vitamin D3	intralesional vitamin D3	Combined Military Hospital Abbottabad	marketed	Vitamin D analog / immunomodulator	Vitamin D receptor (VDR)
Calcifediol (Vitamin D)	Calcifediol (Vitamin D)	Maimónides Biomedical Research Institute of Córdoba	marketed	Vitamin D analog	Vitamin D receptor (VDR)
cholecalciferol (vitamin D3)	cholecalciferol (vitamin D3)	Medical University of South Carolina	marketed	Vitamin D analog / Secosteroid	Vitamin D receptor (VDR)
Enstilar 0.005%-0.064% Topical Foam	Enstilar 0.005%-0.064% Topical Foam	Psoriasis Treatment Center of Central New Jersey	marketed	Corticosteroid + Vitamin D analog combination	Glucocorticoid receptor; Vitamin D receptor (VDR)
calcipotriene + clobetasol propionate	calcipotriene + clobetasol propionate	Leon Kircik, M.D.	marketed	Topical combination therapy (vitamin D analog + corticosteroid)	Vitamin D receptor (VDR) and glucocorticoid receptor (GR)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2026-05-26 — Dovonex · 8629128 · Formulation · US
• 2028-05-07 — Dovonex · 8263580 · Formulation · US

Sponsor landscape (Vitamin D analog class)

1. LEO Pharma · 2 drugs in this class
2. Genzyme, a Sanofi Company · 2 drugs in this class
3. National Cancer Institute, Naples · 2 drugs in this class
4. OPKO Health, Inc. · 2 drugs in this class
5. Joslin Diabetes Center · 1 drug in this class
6. Kyowa Kirin, Inc. · 1 drug in this class
7. Maimónides Biomedical Research Institute of Córdoba · 1 drug in this class
8. Shanghai Jiao Tong University Affiliated Sixth People's Hospital · 1 drug in this class
9. Shiraz University of Medical Sciences · 1 drug in this class
10. St. Justine's Hospital · 1 drug in this class