Arimoclomol citrate - Generic Drug Details
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What are the generic sources for arimoclomol citrate and what is the scope of patent protection?
Arimoclomol citrate
is the generic ingredient in one branded drug marketed by Zevra Denmark and is included in one NDA. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for arimoclomol citrate
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Patent Applications: | 20 |
| What excipients (inactive ingredients) are in arimoclomol citrate? | arimoclomol citrate excipients list |
| DailyMed Link: | arimoclomol citrate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for arimoclomol citrate
Generic Entry Date for arimoclomol citrate*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
CAPSULE;ORAL |
*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 arimoclomol citrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Orphazyme | Phase 3 |
US Patents and Regulatory Information for arimoclomol citrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zevra Denmark | MIPLYFFA | arimoclomol citrate | CAPSULE;ORAL | 214927-003 | Sep 20, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zevra Denmark | MIPLYFFA | arimoclomol citrate | CAPSULE;ORAL | 214927-002 | Sep 20, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zevra Denmark | MIPLYFFA | arimoclomol citrate | CAPSULE;ORAL | 214927-004 | Sep 20, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zevra Denmark | MIPLYFFA | arimoclomol citrate | CAPSULE;ORAL | 214927-001 | Sep 20, 2024 | RX | Yes | 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 |
