ACTHAR GEL Drug Patent Profile
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Which patents cover Acthar Gel, and when can generic versions of Acthar Gel launch?
Acthar Gel is a drug marketed by Mallinckrodt Ireland and is included in one NDA. There is one patent protecting this drug.
The generic ingredient in ACTHAR GEL is corticotropin. There is one drug master file entry 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 Gel
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 18, 2041. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for ACTHAR GEL?
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Summary for ACTHAR GEL
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 78 |
| DailyMed Link: | ACTHAR GEL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ACTHAR GEL
Generic Entry Date for ACTHAR GEL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INJECTION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ACTHAR GEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Toyos Clinic | PHASE4 |
| University of North Carolina, Chapel Hill | Phase 4 |
| University of California, San Francisco | Phase 4 |
Pharmacology for ACTHAR GEL
| Drug Class | Adrenocorticotropic Hormone |
US Patents and Regulatory Information for ACTHAR GEL
ACTHAR GEL is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ACTHAR GEL is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt Ireland | ACTHAR GEL | corticotropin | INJECTABLE;INJECTION | 008372-006 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mallinckrodt Ireland | ACTHAR GEL (AUTOINJECTOR) | corticotropin | INJECTABLE;INJECTION | 008372-004 | Feb 29, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mallinckrodt Ireland | ACTHAR GEL | corticotropin | INJECTABLE;INJECTION | 008372-008 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mallinckrodt Ireland | ACTHAR GEL (AUTOINJECTOR) | corticotropin | INJECTABLE;INJECTION | 008372-003 | Feb 29, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
