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. 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
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Questions you can ask:
- What is the 5 year forecast for ACTHAR?
- What are the global sales for ACTHAR?
- What is Average Wholesale Price for ACTHAR?
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 |
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 |
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 | ||||
| Sanofi Aventis Us | ACTHAR | corticotropin | INJECTABLE;INJECTION | 007504-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 |
