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ZEMPLAR

NDA

PARICALCITOL | N021606 | 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

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 Macleods Pharmaceuticals Limited FDA-2017-P-5090 · 4 docket documents Macleods Pharmaceuticals Limited filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Bionpharma Inc.'s approved ANDA number A202539 for Paricalcitol Capsule in strengths of 1 microgram, 2 microgram, and 4 microgram as a refer	505(q)	2017-08-22	Partially Denied	Macleods Pharmaceuticals Limited

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

Clinical Trials

82 trials from ClinicalTrials.gov, 63 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease NCT00796679	N/A	Completed	The University of Hong Kong	60	2008-10 → 2011-06
A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects NCT00053378	Phase 2	Completed	Abbott	45	2002-01
A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease NCT00257920	Phase 4	Completed	Abbott	41	2006-06
The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors NCT00421733	Phase 2	Completed	Abbott	281	2006-12 → 2009-06
Bioequivalence Study of Paricalcitol Capsules, 4 mcg Under Fasting Conditions NCT02322632	Phase 1	Completed	Dr. Reddy's Laboratories Limited	69	2010-11 → 2011-02
Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)NCT01020487	Phase 3	Completed	AbbVie (prior sponsor, Abbott)	47	2010-02 → 2014-12
Pembrolizumab and Paricalcitol With or Without Chemotherapy in Patients With Pancreatic Cancer That Can Be Removed by Surgery NCT02930902	Phase 1	Completed	M.D. Anderson Cancer Center	9	2017-02-20 → 2023-01-03
Paricalcitol in Treating Patients With Myelodysplastic Syndrome NCT00064376	Phase 2	Completed	Cedars-Sinai Medical Center	—	2003-05 → 2005-11
Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)NCT00701805	Phase 2	Completed	Abbott	107	2008-07 → 2009-12
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)NCT00823303	Phase 4	Completed	Washington University School of Medicine	110	2009-02 → 2013-09

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$254.98

Highest Price

$509.95

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00074-9036-30ZEMPLAR 1MCG CAPSULES	$254.98	FSS	Abbvie US LLC	07/31/2030
00074-9036-30ZEMPLAR 1MCG CAPSULES	$254.98	Big4	Abbvie US LLC	07/31/2030
00074-9037-30ZEMPLAR 2MCG CAPSULES	$509.95	FSS	Abbvie US LLC	07/31/2030
00074-9037-30ZEMPLAR 2MCG CAPSULES	$509.95	Big4	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain10 active DMFs1 inactive

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

MICROBIOPHARM JAPAN CO LTDInactivePARICALCITOL, USP

DMF 271452013

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Oct 20, 2016	SUPPL -16	View Letter (PDF)
Oct 20, 2016	SUPPL -17	View Letter (PDF)
Sep 3, 2014	SUPPL -12	View Letter (PDF)
Sep 3, 2014	SUPPL -14	View Letter (PDF)
Apr 19, 2011	SUPPL -9	View Letter (PDF)
Apr 11, 2011	SUPPL -9	View Letter (PDF)
Jun 15, 2010	SUPPL -7	View Letter (PDF)
Jul 7, 2009	SUPPL -4	View Letter (PDF)
May 27, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1MCG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 26, 2005

No patent or exclusivity listings for this strength.

#002 — 2MCG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 26, 2005

#003 — 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 26, 2005