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HICON

NDA

SODIUM IODIDE I-131 | N021305 | JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA

6 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Jubilant DraxImage Inc. FDA-2017-P-4586 · 3 docket documents Jubilant DraxImage Inc., the NDA holder for HICON (sodium iodide I-131 solution and capsules approved under NDA 021305), filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA refrain from approving any ANDA referencing HICON unle	505(q)	2017-08-03	Denied	Jubilant DraxImage Inc.
International Isotopes, Inc (I3) - Citizen Petition FDA-2013-P-0219 · 3 docket documents International Isotopes, Inc. submitted a suitability petition requesting FDA agreement to increase the strength of sodium iodide I-131 in its proposed generic kit for preparation of oral solutions and capsules from 250-1000 mCi/mL to 500-3500 mCi/mL at calibration, based on the reference listed drug	Other	2013-03-08	Granted	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF2 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

UNIV MISSOURI RESEARCH REACTOR CENTERSODIUM IODIDE I-131 SOLUTION

DMF 328542018

NORDION CANADA INCInactiveSODIUM IODIDE I-131

DMF 63721986

MDS NORDIONInactiveSODIUM IODIDE I-131

DMF 92291991

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Jun 15, 2021	SUPPL -47	View Letter (PDF)
Jul 12, 2016	SUPPL -42	View Letter (PDF)
Jun 21, 2016	SUPPL -41	View Letter (PDF)
Oct 5, 2011	SUPPL -27	View Letter (PDF)
Sep 28, 2011	SUPPL -25	View Letter (PDF)
Mar 4, 2008	SUPPL -16	View Letter (PDF)
Apr 25, 2007	SUPPL -11	View Letter (PDF)
Oct 26, 2006	SUPPL -10	View Letter (PDF)
Jan 20, 2006	SUPPL -5	View Letter (PDF)
May 20, 2005	SUPPL -3	View Letter (PDF)
Dec 2, 2004	SUPPL -2	View Letter (PDF)
Aug 15, 2003	SUPPL -1	View Letter (PDF)
Jan 24, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

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#002 — 1-250mCi/0.25ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jan 24, 2003

No patent or exclusivity listings for this strength.

#003 — 1-500mCi/0.5ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Jan 24, 2003

#005 — 1-1000mCi/ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Apr 4, 2006

#007 — 250-1000mCi

RLDAA

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Dec 5, 2011

#004 — 2-200mCi

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 18, 2004

#006 — 0.009-0.1mCi

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 19, 2005