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PARICALCITOL

NDA

PARICALCITOL | N205917 | HIKMA PHARMACEUTICALS CO LTD

3 strengths0 unique patents0 unique exclusivities

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AbbVie Inc. et al v. Hikma Pharmaceutical Co Ltd. et al 1:2013cv01557 1 patentparicalcitol	D. Del.	2013-09-13	Terminated 2014-03-20	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain10 active DMFs

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

SAFC INCPARICALCITOL

DMF 113401995

TAPI NL BVPARICALCITOL USP

DMF 208652007

ALP PHARM BEIJING CO LTDPARICALCITOL USP (NON-STERILE DRUG SUBSTANCE)

DMF 212552008

FORMOSA LABORATORIES INCPARICALCITOL

DMF 218802008

NEULAND LABORATORIES LTDPARICALCITOL USP

DMF 238952010

ABBVIE INCPARICALCITOL DRUG SUBSTANCE

DMF 243152010

DISHMAN NETHERLANDS BVPARICALCITOL

DMF 253002011

SAI LIFE SCIENCES LTDPARICALCITOL USP, NON-STERILE BULK DRUG

DMF 265452012

CHONGQING HUAPONT PHARMACEUTICAL CO LTDPARICALCITOL

DMF 285502014

NANJING HERON PHARMACEUTICAL CO LTDPARICALCITOL

DMF 382692023

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 18, 2026	SUPPL -3	View Letter (PDF)
Nov 19, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.002MG/ML (0.002MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Nov 18, 2014

No patent or exclusivity listings for this strength.

#002 — 0.005MG/ML (0.005MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 18, 2014

#003 — 0.01MG/2ML (0.005MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 18, 2014