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Last Updated: November 22, 2024

ACTHAR Drug Patent Profile


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Which patents cover Acthar, and when can generic versions of Acthar launch?

Acthar is a drug marketed by Sanofi Aventis Us and Mallinckrodt Ard and is included in two NDAs. There is one patent protecting this drug.

The generic ingredient in ACTHAR is corticotropin. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the corticotropin profile page.

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Indicators of Generic Entry

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Summary for ACTHAR
US Patents:0
Applicants:2
NDAs:2
Clinical Trials: 77
What excipients (inactive ingredients) are in ACTHAR?ACTHAR excipients list
DailyMed Link:ACTHAR at DailyMed
Drug patent expirations by year for ACTHAR
Recent Clinical Trials for ACTHAR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of North Carolina, Chapel HillPhase 4
University of California, San FranciscoPhase 4
Johns Hopkins UniversityEarly Phase 1

See all ACTHAR clinical trials

US Patents and Regulatory Information for ACTHAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us ACTHAR corticotropin INJECTABLE;INJECTION 007504-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mallinckrodt Ard ACTHAR GEL (AUTOINJECTOR) corticotropin INJECTABLE;INJECTION 008372-003 Feb 29, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mallinckrodt Ard ACTHAR GEL corticotropin INJECTABLE;INJECTION 008372-008 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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