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ZEMPLAR

NDA

PARICALCITOL | N020819 | ABBVIE INC

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AbbVie Inc. et al v. Sun Pharmaceutical Industries Ltd. et al 1:2013cv00138 1 patentANDA 20-4564paricalcitol	D. Del.	2013-01-24	Terminated 2013-05-20	—
Abbott Laboratories et al v. Hospira Inc. 1:2012cv00234 4 patentsparicalcitol	D. Del.	2012-02-27	Terminated 2014-12-10	—

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

Medicare Part D Spending

CMS annual spending data for Paricalcitol* (2023)

Total Spending

$4.5M

Total Claims

28,839

Beneficiaries

6,778

Avg Cost/Unit

$3.49

Spending Trend

$9.5M(2019)→$35K(2019)→$7.2M(2020)→$38K(2020)→$5.5M(2021)→$18K(2021)→$24K(2022)→$5.4M(2022)→$4.5M(2023)→$19K(2023)

YoY Change:-10.0%

5yr CAGR:-6.3%

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

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

13 letters from Drugs@FDA

Date	Submission	Document
Oct 21, 2022	SUPPL -38	View Letter (PDF)
Aug 12, 2021	SUPPL -37	View Letter (PDF)
Mar 3, 2021	SUPPL -36	View Letter (PDF)
Dec 12, 2018	SUPPL -30	View Letter (PDF)
Apr 11, 2011	SUPPL -25	View Letter (PDF)
Feb 4, 2011	SUPPL -24	View Letter (PDF)
Nov 19, 2009	SUPPL -21	View Letter (PDF)
Sep 8, 2005	SUPPL -15	View Letter (PDF)
Apr 7, 2004	SUPPL -14	View Letter (PDF)
Mar 10, 2003	SUPPL -7	View Letter (PDF)
Mar 10, 2003	SUPPL -11	View Letter (PDF)
Feb 2, 2000	SUPPL -3	View Letter (PDF)
Apr 17, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.005MG/ML (0.005MG/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Apr 17, 1998

No patent or exclusivity listings for this strength.

#002 — 0.002MG/ML (0.002MG/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 1, 2000

#003 — 0.01MG/2ML (0.005MG/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 1, 2000