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PURIFIED CORTROPHIN GEL

NDA

CORTICOTROPIN | N008975 | ANI PHARMACEUTICALS INC

2 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

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Today

Oct. 27, 2043

Oct. 27, 2043

Oct. 27, 2043

Oct. 27, 2043

Oct. 27, 2043

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

41 trials from ClinicalTrials.gov, 22 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Two-Arm Study Evaluation H.P. Acthar Injection Gel in Treatment of Chronic Migraines NCT01813591	Phase 2	Completed	Dent Neuroscience Research Center	20	2013-04 → 2015-11
Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations NCT01888354	Phase 4	Completed	The University of Texas Health Science Center, Houston	25	2013-04 → 2014-08
Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease NCT03287635	Phase 4	Completed	Toyos Clinic	19	2018-07-01 → 2020-03-04
Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)NCT02258217	N/A	Completed	OhioHealth	30	2014-06 → 2016-12
A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis NCT01906658	Phase 2	Completed	Mallinckrodt	43	2013-07 → 2014-12
Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures NCT01673087	Phase 1	Completed	University of Michigan	256	2012-10 → 2017-08-15
Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism NCT00666068	N/A	Completed	Max-Planck-Institute of Psychiatry	30	2008-02 → 2008-12
Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock NCT00005890	N/A	Completed	National Center for Research Resources (NCRR)	56	1996-03
Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease NCT01753401	Phase 4	Completed	Mallinckrodt	38	2013-01 → 2015-10
Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment NCT00004758	Phase 2	Completed	National Center for Research Resources (NCRR)	30	1993-11

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

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$2803.04

Highest Price

$33438.13

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62559-0860-11CORTROPHIN 80UNT/ML INJ,GEL	$7343.56	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0860-11CORTROPHIN 80UNT/ML INJ,GEL	$5032.79	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0860-15CORTROPHIN 80UNT/ML INJ,GEL	$33438.13	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0860-15CORTROPHIN 80UNT/ML INJ,GEL	$25142.14	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0861-11CORTICOTROPIN 80UNT/ML INJ,GEL,SYR,1ML	$7383.71	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0861-11CORTICOTROPIN 80UNT/ML INJ,GEL,SYR,1ML	$5611.62	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0861-35CORTICOTROPIN 80UNT/ML INJ,GEL,SYR,0.5ML	$3692.35	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0861-35CORTICOTROPIN 80UNT/ML INJ,GEL,SYR,0.5ML	$2803.04	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027

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

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

3 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2025	SUPPL -16	View Letter (PDF)
Dec 16, 2024	SUPPL -15	View Letter (PDF)
Oct 27, 2023	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40 UNITS/ML

1 patent0 exclusivities▴

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

Patents (1) · 23 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12102662	Oct 27, 2043	—	—	—		—

#002 — 80 UNITS/ML

RLD

5 patents0 exclusivities▾

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