Generic Miplyffa Availability
Last updated on May 7, 2025.
Miplyffa is a brand name of arimoclomol, approved by the FDA in the following formulation(s):
MIPLYFFA (arimoclomol citrate - capsule;oral)
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Manufacturer: ZEVRA DENMARK
Approval date: September 20, 2024
Strength(s): EQ 47MG BASE [RLD], EQ 62MG BASE [RLD], EQ 93MG BASE [RLD], EQ 124MG BASE [RLD]
Is there a generic version of Miplyffa available?
No. There is currently no therapeutically equivalent version of Miplyffa available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Miplyffa. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Use of Hsp70 as a regulator of enzymatic activity
Patent 11,045,460
Issued: June 29, 2021
Inventor(s): Jensen; Thomas Kirkegaard et al.
Assignee(s): Orphazyme A/S (Copenhagen, DK)The present invention concerns a method for modulating the enzymatic activity of an enzyme, wherein said enzyme interacts with BMP, said method comprising the step of administering or inducing Hsp70, or a functional fragment or variant thereof, in a form suitable for allowing interaction between BMP and Hsp70, or said functional fragment or variant thereof, and thereby modulating the enzymatic activity of an enzyme interacting with BMP.
Patent expiration dates:
- August 19, 2029✓
- August 19, 2029
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Use of HSP70 as a regulator of enzymatic activity
Patent 9,289,472
Issued: March 22, 2016
Inventor(s): Jensen; Thomas Kirkegaard et al.
Assignee(s): Orphazyme Aps (København N, DK)The present invention concerns a method for modulating the enzymatic activity of an enzyme, wherein said enzyme interacts with BMP, said method comprising the step of administering or inducing Hsp70, or a functional fragment or variant thereof, in a form suitable for allowing interaction between BMP and Hsp70, or said functional fragment or variant thereof, and thereby modulating the enzymatic activity of an enzyme interacting with BMP.
Patent expiration dates:
- August 11, 2029✓
- August 11, 2029
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Use of Hsp70 as a regulator of enzymatic activity
Patent 9,884,058
Issued: February 6, 2018
Inventor(s): Jensen; Thomas Kirkegaard et al.
Assignee(s): Orphazyme ApS (København N, DK)The present invention concerns a method for modulating the enzymatic activity of an enzyme, wherein said enzyme interacts with BMP, said method comprising the step of administering or inducing Hsp70, or a functional fragment or variant thereof, in a form suitable for allowing interaction between BMP and Hsp70, or said functional fragment or variant thereof, and thereby modulating the enzymatic activity of an enzyme interacting with BMP.
Patent expiration dates:
- June 26, 2029✓
- June 26, 2029
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- September 20, 2029 - NEW CHEMICAL ENTITY
- September 20, 2031 - TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER
More about Miplyffa (arimoclomol)
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- Drug class: miscellaneous metabolic agents
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.