doxercalciferol capsules, Hectorol® — Competitive Intelligence Brief

doxercalciferol capsules, Hectorol® (doxercalciferol capsules, Hectorol®) 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

doxercalciferol capsules, Hectorol® (doxercalciferol capsules, Hectorol®) — Genzyme, a Sanofi Company. Doxercalciferol is a vitamin D analog that activates the vitamin D receptor to regulate calcium and phosphate metabolism and suppress parathyroid hormone (PTH) secretion.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
doxercalciferol capsules, Hectorol® TARGET	doxercalciferol capsules, Hectorol®	Genzyme, a Sanofi Company	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)
Taclonex Ointment and Hydrogel Patch	Taclonex Ointment and Hydrogel Patch	University of California, San Francisco	marketed	Combination topical agent (vitamin D analog + corticosteroid)	Vitamin D receptor (VDR) and glucocorticoid receptor (GR)
Calcipotriene + Betamethasone Dipropionate	Calcipotriene + Betamethasone Dipropionate	Odense University Hospital	marketed	Vitamin D analog + Corticosteroid combination	Vitamin D receptor (VDR) and Glucocorticoid receptor (GR)
Calcipotriene/betamethasone	Calcipotriene/betamethasone	Derm Research, PLLC	marketed	Vitamin D analog / Corticosteroid combination	Vitamin D receptor (VDR) / Glucocorticoid receptor (GR)
Calcitriol (Rocaltrol®)	Calcitriol (Rocaltrol®)	Joslin Diabetes Center	marketed	Vitamin D analog	Vitamin D receptor (VDR)

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