Miplyffa is a drug owned by Zevra Denmark As. It is protected by 3 US drug patents filed in 2024 out of which none have expired yet. Miplyffa's patents will be open to challenges from 20 September, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 20, 2031. Details of Miplyffa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11045460 | Use of Hsp70 as a regulator of enzymatic activity |
Aug, 2029
(3 years from now) | Active |
| US9289472 | Use of HSP70 as a regulator of enzymatic activity |
Aug, 2029
(3 years from now) | Active |
| US9884058 | Use of Hsp70 as a regulator of enzymatic activity |
Jun, 2029
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Miplyffa's patents.
Latest Legal Activities on Miplyffa's Patents
Given below is the list of recent legal activities going on the following patents of Miplyffa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 26 Aug, 2025 | US11045460 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 12 Aug, 2025 | US9884058 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 12 Aug, 2025 | US11045460 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 12 Aug, 2025 | US9289472 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 05 Aug, 2025 | US9884058 |
| Second letter to regulating agency to determine regulatory review period | 13 Jun, 2025 | US11045460 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Mar, 2025 | US11045460 |
| Initial letter Re: PTE Application to regulating agency | 02 Dec, 2024 | US11045460 |
| Patent Term Extension Application under 35 USC 156 Filed | 15 Nov, 2024 | US11045460 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 08 Oct, 2024 | US11045460 |
FDA has granted several exclusivities to Miplyffa. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Miplyffa, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Miplyffa.
Exclusivity Information
Miplyffa holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Miplyffa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 20, 2029 |
| Orphan Drug Exclusivity(ODE-496) | Sep 20, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Miplyffa is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Miplyffa's family patents as well as insights into
ongoing legal events
on those patents.
Miplyffa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Miplyffa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 20, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Miplyffa Generics:
There are no approved generic versions for Miplyffa as of now.
About Miplyffa
Miplyffa is a drug owned by Zevra Denmark As. Miplyffa uses Arimoclomol Citrate as an active ingredient. Miplyffa was launched by Zevra in 2024.
Approval Date:
Miplyffa was approved by FDA for market use on 20 September, 2024.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Miplyffa is 20 September, 2024, its NCE-1 date is estimated to be 20 September, 2028.
Active Ingredient:
Miplyffa uses Arimoclomol Citrate as the active ingredient. Check out other Drugs and Companies using Arimoclomol Citrate ingredient
Dosage:
Miplyffa is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 124MG BASE | CAPSULE | Prescription | ORAL |
| EQ 47MG BASE | CAPSULE | Prescription | ORAL |
| EQ 93MG BASE | CAPSULE | Prescription | ORAL |
| EQ 62MG BASE | CAPSULE | Prescription | ORAL |