Viewing data from:

CALCIJEX

NDA

CALCITRIOL | N018874 | ABBVIE INC

2 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

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Gland Pharma Ltd. FDA-2015-P-0543 Gland Pharma Limited filed this petition pursuant to Section 505(j)(2)(C) of the FDC Act and 21 CFR 314.93, requesting that FDA designate the most commercially active generic Calcitriol Injection, USP 1 mcg/mL and 2 mcg/mL approved under ANDAs as a second Reference Listed Drug in the Orange Book, si	505(q)	2015-02-20	Denied	Gland Pharma Ltd.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain5 active DMFs2 inactive

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

TAPI NL BVCALCITRIOL USP

DMF 124171997

CARBOGEN AMCIS BVCALCITRIOL

DMF 140931999

CERBIOS PHARMA SACALCITRIOL

DMF 147182000

MICROBIOPHARM JAPAN CO LTDCALCITRIOL

DMF 151282000

FORMOSA LABORATORIES INCCALCITRIOL

DMF 182272005

DUPHAR BVInactiveCALCITRIOL

DMF 65471986

CATALENT PHARMA SOLUTIONS LLCInactiveCALCITRIOL 0.25 MCG SOFT GELATIN CAPSULES

DMF 169742003

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 14, 2012	SUPPL -22	View Letter (PDF)
Jul 5, 2007	SUPPL -19	View Letter (PDF)
Jul 30, 2003	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 25, 1986

No patent or exclusivity listings for this strength.

#002 — 0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 25, 1986