Viewing data from:

ACTHAR GEL (AUTOINJECTOR)

NDA

CORTICOTROPIN | N008372 | MALLINCKRODT PHARMACEUTICALS IRELAND LTD

4 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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11752199

Jul. 18, 2041

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs7 inactive

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

ORTHANA KEMISK FABRIK A SInactiveCORTICOTROPIN - GEL

DMF 2781957

FREDERIKSBERG CHEMICAL LABORATORIES LTDInactiveCORTICOTROPIN (ACTH)

DMF 17801971

MERCK SHARP AND DOHME BVInactiveCORTICOTROPIN

DMF 41811981

SALK INSTITUTEInactiveCORTICOTROPIN RELEASING FACTOR (CRF)

DMF 43841981

PENINSULA LABS INCInactiveCORTICOTROPIN RELEASING FACTOR (HUMAN RAT CRF)

DMF 58321985

BACHEM FINE CHEMICALS INCInactiveCORTICOTROPIN RELEASING FACTORS (CRF), (HUMAN, RAT)

DMF 62401986

PENINSULA LABS INCInactiveCORTICOTROPIN RELEASING FACTOR

DMF 73781988

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Mar 1, 2024	SUPPL -74	View Letter (PDF)
Nov 1, 2021	SUPPL -71	View Letter (PDF)
Mar 3, 2021	SUPPL -68	View Letter (PDF)
Mar 27, 2019	SUPPL -61	View Letter (PDF)
May 1, 2018	SUPPL -57	View Letter (PDF)
Mar 25, 2015	SUPPL -44	View Letter (PDF)
Jul 9, 2012	SUPPL -45	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#006 — 40 UNITS/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#008 — 80 UNITS/ML

RLD

1 patent0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 40 UNITS/0.5ML

RLD

1 patent0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 29, 2024

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11752199	Jul 18, 2041	—	—	—		—

#004 — 80 UNITS/ML

RLD

1 patent0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 29, 2024