MIPLYFFA Drug Patent Profile
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Which patents cover Miplyffa, and when can generic versions of Miplyffa launch?
Miplyffa is a drug marketed by Zevra Denmark and is included in one NDA.
The generic ingredient in MIPLYFFA is arimoclomol citrate. One supplier is listed for this compound. Additional details are available on the arimoclomol citrate profile page.
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Summary for MIPLYFFA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 222 |
| What excipients (inactive ingredients) are in MIPLYFFA? | MIPLYFFA excipients list |
| DailyMed Link: | MIPLYFFA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MIPLYFFA
*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.
US Patents and Regulatory Information for MIPLYFFA
MIPLYFFA is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MIPLYFFA is ⤷ Sign Up.
This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting MIPLYFFA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | 214927-001 | 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 | 214927-002 | Sep 20, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zevra Denmark | MIPLYFFA | arimoclomol citrate | CAPSULE;ORAL | 214927-003 | 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 |
