Joenja is a drug owned by Pharming Technologies Bv. It is protected by 1 US drug patent filed in 2023 out of which none have expired yet. Joenja's patents will be open to challenges from 25 March, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 19, 2032. Details of Joenja'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. | |||
| US8653092 | Tetrahydro-pyrido-pyrimidine derivatives |
Feb, 2032
(7 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 Joenja's patents.
Latest Legal Activities on Joenja's Patents
Given below is the list of recent legal activities going on the following patents of Joenja.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 15 May, 2024 | US8653092 |
| Letter from FDA or Dept of Agriculture re PTE application | 07 Feb, 2024 | US8653092 |
| Initial letter Re: PTE Application to regulating agency | 01 Dec, 2023 | US8653092 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 27 Oct, 2023 | US8653092 |
| Requirement for information sent under 37 CFR 1.750 | 01 Sep, 2023 | US8653092 |
| Electronic Review Critical | 29 May, 2023 | US8653092 |
| Change in Power of Attorney (May Include Associate POA) Critical | 23 May, 2023 | US8653092 |
| Email Notification Critical | 23 May, 2023 | US8653092 |
| Patent Term Extension Application under 35 USC 156 Filed | 22 May, 2023 | US8653092 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Aug, 2021 | US8653092 |
FDA has granted several exclusivities to Joenja. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Joenja, 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 Joenja.
Exclusivity Information
Joenja holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Joenja's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 24, 2028 |
| Orphan Drug Exclusivity(ODE-430) | Mar 24, 2030 |
US patents provide insights into the exclusivity only within the United States, but Joenja 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 Joenja's family patents as well as insights into ongoing legal events on those patents.
Joenja's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Joenja's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 19, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Joenja Generics:
There are no approved generic versions for Joenja as of now.
About Joenja
Joenja is a drug owned by Pharming Technologies Bv. Joenja uses Leniolisib Phosphate as an active ingredient. Joenja was launched by Pharming in 2023.
Approval Date:
Joenja was approved by FDA for market use on 24 March, 2023.
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 Joenja is 24 March, 2023, its NCE-1 date is estimated to be 25 March, 2027.
Active Ingredient:
Joenja uses Leniolisib Phosphate as the active ingredient. Check out other Drugs and Companies using Leniolisib Phosphate ingredient
Dosage:
Joenja is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 70MG BASE | TABLET | Prescription | ORAL |