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 Ard and is included in one NDA. There is one patent protecting this drug.
The generic ingredient in ACTHAR GEL 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.
DrugPatentWatch® Generic Entry Outlook for Acthar Gel
Indicators of Generic Entry
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Summary for ACTHAR GEL
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 77 |
| DailyMed Link: | ACTHAR GEL at DailyMed |
Recent Clinical Trials for ACTHAR GEL
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 |
Pharmacology for ACTHAR GEL
| Drug Class | Adrenocorticotropic Hormone |
US Patents and Regulatory Information for ACTHAR GEL
ACTHAR GEL is protected by three US patents.
Patents protecting ACTHAR GEL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OPHTHALMIC DISEASES WITH CORTICOTROPIN BY PROMOTING NEW VESSEL FORMATION WHEREIN VCAM-1 EXPRESSION AND ANGIOPOETIN-2 EXPRESSION IS INCREASED AFTER THE ADMINISTERING
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt Ard | ACTHAR GEL | corticotropin | INJECTABLE;INJECTION | 008372-006 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mallinckrodt Ard | ACTHAR GEL (AUTOINJECTOR) | corticotropin | INJECTABLE;INJECTION | 008372-004 | 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 | ||||
| Mallinckrodt Ard | ACTHAR GEL (AUTOINJECTOR) | corticotropin | INJECTABLE;INJECTION | 008372-003 | Feb 29, 2024 | 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 |
