You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 22, 2024

Details for New Drug Application (NDA): 008372


✉ Email this page to a colleague

« Back to Dashboard


NDA 008372 describes ACTHAR GEL, which is a drug marketed by Mallinckrodt Ard and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ACTHAR GEL profile page.

The generic ingredient in ACTHAR GEL is corticotropin. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the corticotropin profile page.
Summary for 008372
Tradename:ACTHAR GEL
Applicant:Mallinckrodt Ard
Ingredient:corticotropin
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 008372
Suppliers and Packaging for NDA: 008372
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTHAR GEL corticotropin INJECTABLE;INJECTION 008372 NDA Mallinckrodt ARD LLC 63004-8710 63004-8710-1 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-1) / 5 mL in 1 VIAL, MULTI-DOSE
ACTHAR GEL corticotropin INJECTABLE;INJECTION 008372 NDA Mallinckrodt ARD LLC 63004-8710 63004-8710-2 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-2) / 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength40 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 008

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 25, 2041Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF EXACERBATIONS OF MULTIPLE SCLEROSIS IN ADULTS WITH CORTICOTROPIN BY PROMOTING NEW VESSEL FORMATION WHEREIN VCAM-1 EXPRESSION AND ANGIOPOETIN-2 EXPRESSION IS INCREASED AFTER THE ADMINISTERING
Patent:⤷  Try a TrialPatent Expiration:Feb 25, 2041Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFANTILE SPASMS WITH CORTICOTROPIN BY PROMOTING NEW VESSEL FORMATION WHEREIN VCAM-1 EXPRESSION AND ANGIOPOETIN-2 EXPRESSION IS INCREASED AFTER THE ADMINISTERING

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.