Calcifediol Oral Product — Competitive Intelligence Brief

Calcifediol Oral Product (Calcifediol Oral Product) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Vitamin D analog. Area: Endocrinology / Nephrology.

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

Target snapshot

Calcifediol Oral Product (Calcifediol Oral Product) — OPKO Health, Inc.. Calcifediol is an active vitamin D metabolite that binds to the vitamin D receptor to regulate calcium and phosphate homeostasis and modulate immune function.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Calcifediol Oral Product TARGET	Calcifediol Oral Product	OPKO Health, Inc.	marketed	Vitamin D analog	Vitamin D receptor (VDR)
Dovonex	CALCIPOTRIENE		marketed	Vitamin D Analog [EPC]	Vitamin D3 receptor	1993-01-01
Kalcipos-D	Kalcipos-D	Takeda	marketed	Vitamin D analog with calcium supplement	Vitamin D receptor (VDR)
Eldecalcitol capsules	Eldecalcitol capsules	Shanghai Jiao Tong University Affiliated Sixth People's Hospital	marketed	Vitamin D analog	Vitamin D receptor (VDR)
doxercalciferol capsules, Hectorol®	doxercalciferol capsules, Hectorol®	Genzyme, a Sanofi Company	marketed	Vitamin D analog	Vitamin D receptor (VDR)
doxercalciferol capsules, Hectorol® capsules	doxercalciferol capsules, Hectorol® capsules	Genzyme, a Sanofi Company	marketed	Vitamin D analog	Vitamin D receptor (VDR)
Calcipotriene and betamethasone dipropionate ointment	Calcipotriene and betamethasone dipropionate ointment	Galderma R&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