ACTHAR Drug Patent Profile
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Which patents cover Acthar, and what generic alternatives are available?
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. Two suppliers are listed for this compound. Additional details are available on the corticotropin profile page.
DrugPatentWatch® Generic Entry Outlook for Acthar
Indicators of Generic Entry
Summary for ACTHAR
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Clinical Trials: | 77 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in ACTHAR? | ACTHAR excipients list |
DailyMed Link: | ACTHAR at DailyMed |
Recent Clinical Trials for ACTHAR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of North Carolina, Chapel Hill | Phase 4 |
University of California, San Francisco | Phase 4 |
Johns Hopkins University | Early Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for ACTHAR
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mallinckrodt Ard | ACTHAR GEL | corticotropin | INJECTABLE;INJECTION | 008372-008 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sanofi Aventis Us | ACTHAR | corticotropin | INJECTABLE;INJECTION | 007504-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mallinckrodt Ard | ACTHAR GEL | corticotropin | INJECTABLE;INJECTION | 008372-006 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |