Wakix is a drug owned by Harmony Biosciences Llc. It is protected by 5 US drug patents filed in 2019. Out of these, 3 drug patents are active and 2 have expired. Wakix's patents have been open to challenges since 15 August, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 21, 2031. Details of Wakix's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8207197 | Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy] propyl] -piperidine |
Mar, 2030
(5 years from now) | Active |
| US7169928 | Non-imidazole alkylamines as histamine H3-receptor ligands and their therapeutic applications |
Feb, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8486947 | Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H3-receptor ligands |
Sep, 2029
(4 years from now) | Active |
| US8354430 | Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine |
Feb, 2026
(1 year, 1 month from now) | Active |
| US7910605 | Non-imidazole alkylamines as histamine H3- receptor ligands and their therapeutic applications |
Sep, 2022
(2 years ago) |
Expired
|
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 Wakix's patents.
Latest Legal Activities on Wakix's Patents
Given below is the list of recent legal activities going on the following patents of Wakix.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Yr, Small Entity | 15 Jul, 2024 | US8354430 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 21 Dec, 2023 | US8207197 |
| Email Notification Critical | 08 Aug, 2023 | US8207197 |
| Electronic Review Critical | 08 Aug, 2023 | US8207197 |
| Change in Power of Attorney (May Include Associate POA) Critical | 08 Aug, 2023 | US8207197 |
| Expire Patent Critical | 24 Apr, 2023 | US7910605 |
| Maintenance Fee Reminder Mailed Critical | 07 Nov, 2022 | US7910605 |
| Patent Term Extension Certificate Critical | 06 Oct, 2022 | US8207197 |
| Withdrawal of Application for PTE Critical | 30 Aug, 2022 | US8486947 |
| Notice of Final Determination -Election Required | 11 Jul, 2022 | US8486947 |
FDA has granted several exclusivities to Wakix. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Wakix, 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 Wakix.
Exclusivity Information
Wakix holds 6 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Wakix's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-846) | Oct 13, 2023 |
| New Chemical Entity Exclusivity(NCE) | Aug 14, 2024 |
| Orphan Drug Exclusivity(ODE-255) | Aug 14, 2026 |
| New Patient Population(NPP) | Jun 21, 2027 |
| Orphan Drug Exclusivity(ODE-331) | Oct 13, 2027 |
| Orphan Drug Exclusivity(ODE-489) | Jun 21, 2031 |
Several oppositions have been filed on Wakix's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Wakix's generic, the next section provides detailed information on ongoing and past EP oppositions related to Wakix patents.
Wakix's Oppositions Filed in EPO
Wakix has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 27, 2014, by Sölch, Günter. This opposition was filed on patent number EP06744466A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06744466A | Feb, 2014 | Sölch, Günter | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Wakix 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 Wakix's family patents as well as insights into ongoing legal events on those patents.
Wakix's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Wakix's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 21, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Wakix Generics:
There are no approved generic versions for Wakix as of now.
Alternative Brands for Wakix
Wakix which is used for treating cataplexy in patients with narcolepsy., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Jazz Pharms |
| |||
About Wakix
Wakix is a drug owned by Harmony Biosciences Llc. It is used for treating cataplexy in patients with narcolepsy. Wakix uses Pitolisant Hydrochloride as an active ingredient. Wakix was launched by Harmony in 2019.
Approval Date:
Wakix was approved by FDA for market use on 14 August, 2019.
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 Wakix is 14 August, 2019, its NCE-1 date is estimated to be 15 August, 2023.
Active Ingredient:
Wakix uses Pitolisant Hydrochloride as the active ingredient. Check out other Drugs and Companies using Pitolisant Hydrochloride ingredient
Treatment:
Wakix is used for treating cataplexy in patients with narcolepsy.
Dosage:
Wakix is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 4.45MG BASE | TABLET | Prescription | ORAL |
| EQ 17.8MG BASE | TABLET | Prescription | ORAL |