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MIACALCIN

NDA

CALCITONIN SALMON | N017808 | MYLAN IRELAND LTD

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Meridian Consulting LLC on behalf of MAIVA PHARMA PVT LTD FDA-2022-P-2517 Maiva Pharma Private Limited, filed through Meridian Consulting LLC, submitted a citizen petition requesting that the FDA determine whether Miacalcin (calcitonin salmon, USP) Injection, 100 USP Units/mL, approved under NDA 017808 and held by Mylan Ireland Limited, was voluntarily withdrawn for reaso	505(q)	2022-10-13	Denied	Meridian Consulting LLC on behalf of MAIVA PHARMA PVT LTD

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Miacalcin (2023)

Total Spending

$837K

Total Claims

Beneficiaries

Avg Cost/Unit

$1373.82

Spending Trend

$4.4M(2019)→$5.2M(2020)→$3.2M(2021)→$980K(2022)→$837K(2023)

YoY Change:-7.8%

5yr CAGR:+0.2%

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

API Supply Chain3 active DMFs1 inactive

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

POLYPEPTIDE LABORATORIES SWEDEN ABCALCITONIN (SALMON)

DMF 156842001

AURO PEPTIDES LTDCALCITONIN SALMON USP

DMF 357912021

FRESENIUS KABI IPSUM SRLCALCITONIN SALMON

DMF 377382023

IAF BIOCHEM INTERNATIONAL INCInactiveCALCITONIN

DMF 82351989

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Sep 15, 2017	SUPPL -37	View Letter (PDF)
Feb 3, 2015	SUPPL -36	View Letter (PDF)
Mar 13, 2014	SUPPL -35	View Letter (PDF)
Apr 23, 2012	SUPPL -34	View Letter (PDF)
Jun 8, 2003	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 3, 1986

No patent or exclusivity listings for this strength.

#002 — 200 IU/ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 29, 1991