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MIACALCIN

NDA

CALCITONIN SALMON | N020313 | ALLIED PHARMA INC

1 strength0 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 Foley & Lardner LLP FDA-2005-P-0367 · 6 docket documents Foley & Lardner LLP filed this citizen petition requesting that the FDA not approve any abbreviated new drug applications or new drug applications under section 505(b)(2) for salmon calcitonin nasal spray products citing Miacalcin as the reference listed drug unless applicants demonstrate that the a	505(q)	2008-11-18	Partially DeniedUnverified summary	Foley & Lardner LLP

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

Clinical Trials

15 trials from ClinicalTrials.gov, 12 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study for Patients With Osteoporosis NCT00414973	Phase 3	Completed	Eli Lilly and Company	364	2006-12 → 2008-07
The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries NCT03812991	Phase 4	Completed	University of Missouri-Columbia	21	2019-07-01 → 2023-02-28
Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women NCT00372099	Phase 3	Completed	Rene Rizzoli	90	2007-01 → 2011-11
Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women NCT00411125	Phase 1	Completed	Novartis	86	2006-08 → 2006-11
A Study of the Treatment of Postmenopausal Women With Osteoporosis NCT00543023	Phase 3	Completed	Eli Lilly and Company	104	2003-06 → 2004-08
Calcitonin for Treating X-linked Hypophosphatemia NCT01652573	N/A	Completed	Yale University	21	2011-03 → 2015-09
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study NCT00486369	Phase 1	Completed	Nordic Bioscience A/S	—	2007-01
Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis NCT00486317	Phase 1	Completed	Nordic Bioscience A/S	—	2005-10
A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women NCT00620854	Phase 2	Completed	Tarsa Therapeutics, Inc.	24	2008-02 → 2008-04
Comparison Medications in the Treatment of Postmenopausal Women With Osteoporosis NCT00542984	Phase 3	Completed	Eli Lilly and Company	70	2003-08 → 2004-11

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain3 active DMFs3 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

MALLINCKRODT CHEMICAL INCInactiveCALCITONIN, SALMON

DMF 94631991

POLYPEPTIDE LABORATORIES ASInactiveCALCITONIN (SALMON), PH.EUR.

DMF 127751997

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 -36	View Letter (PDF)
Mar 13, 2014	SUPPL -34	View Letter (PDF)
Apr 23, 2012	SUPPL -33	View Letter (PDF)
Jan 20, 2006	SUPPL -21	View Letter (PDF)
Aug 28, 2003	SUPPL -23	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Aug 17, 1995

No patent or exclusivity listings for this strength.