Viewing data from:

HECTOROL

NDA

DOXERCALCIFEROL | N020862 | SANOFI GENZYME

3 strengths0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

2028

Today

M-14

Jun. 11, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
To Study the Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women in a Long Term 2 Year Study NCT07660536	Phase 2/3	Completed	Creighton University	60	1989-11-14 → 1994-12-23
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis NCT02859896	Phase 3	Terminated	Sanofi	21	2017-01-19 → 2025-06-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Doxercalciferol* (2023)

Total Spending

$701K

Total Claims

1,193

Beneficiaries

317

Avg Cost/Unit

$9.36

Spending Trend

$1.9M(2019)→$1.5M(2020)→$868K(2021)→$821K(2022)→$701K(2023)

YoY Change:+0.6%

5yr CAGR:+3.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs3 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVDOXERCALCIFEROL

DMF 153572001

SAI LIFE SCIENCES LTDDOXERCALCIFEROL USP

DMF 221202008

FORMOSA LABORATORIES INCDOXERCALCIFEROL

DMF 221362008

ALP PHARM BEIJING CO LTDDOXERCALCIFEROL

DMF 251482011

SUN PHARMACEUTICAL INDUSTRIES LTDDOXERCALCIFEROL USP

DMF 255942012

CERBIOS PHARMA SADOXERCALCIFEROL

DMF 283532014

WUXI FORTUNE PHARMACEUTICAL CO LTDDOXERCALCIFEROL

DMF 371322022

CEDARBURG PHARMACEUTICALS LLCInactiveDOXERCALCIFEROL

DMF 153972001

POLYMED THERAPEUTICS INCInactiveDOXERCALCIFEROL DRUG SUBSTANCE

DMF 225902009

LUPIN LTDInactiveDOXERCALCIFEROL

DMF 232332010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jun 12, 2025	SUPPL -33	View Letter (PDF)
Dec 14, 2018	SUPPL -31	View Letter (PDF)
Feb 15, 2011	SUPPL -30	View Letter (PDF)
Jul 17, 2009	SUPPL -24	View Letter (PDF)
Jul 14, 2008	SUPPL -23	View Letter (PDF)
Jul 21, 2006	SUPPL -19	View Letter (PDF)
Jun 29, 2005	SUPPL -18	View Letter (PDF)
Dec 30, 2004	SUPPL -16	View Letter (PDF)
Apr 29, 2004	SUPPL -6	View Letter (PDF)
Jun 9, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MCG

RLD

0 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Jun 9, 1999

Exclusivities (1)

Code	Date	Status
M-14	Jun 11, 2028	Active

#002 — 0.5MCG

RLD

0 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Apr 23, 2004

#003 — 1MCG

RLD

0 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Jul 13, 2009