Isturisa is a drug owned by Recordati Rare Diseases Inc. It is protected by 6 US drug patents filed in 2020 out of which none have expired yet. Isturisa's patents have been open to challenges since 06 March, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 12, 2035. Details of Isturisa'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. | |||
| US9434754 | Use of an adrenal hormone-modifying agent |
Jan, 2031
(5 years from now) | Active |
| US8314097 | Organic compounds |
Mar, 2029
(3 years from now) | Active |
| US8835646 | Organic compounds |
Aug, 2026
(1 year, 3 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10709691 | Pharmaceutical dosage forms |
Oct, 2035
(10 years from now) | Active |
| US10143680 | Pharmaceutical dosage forms |
Jul, 2035
(10 years from now) | Active |
| US8609862 | Use of an adrenal hormone-modifying agent |
Jan, 2031
(5 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 Isturisa's patents.
Latest Legal Activities on Isturisa's Patents
Given below is the list of recent legal activities going on the following patents of Isturisa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 May, 2024 | US8314097 |
| Email Notification Critical | 13 Mar, 2024 | US9434754 |
| Recordation of Patent eCertificate of Correction | 12 Mar, 2024 | US9434754 |
| Patent eCofC Notification | 12 Mar, 2024 | US9434754 |
| Mail Patent eCofC Notification | 12 Mar, 2024 | US9434754 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Mar, 2024 | US9434754 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8314097 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8609862 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US8609862 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US8314097 |
FDA has granted several exclusivities to Isturisa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Isturisa, 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 Isturisa.
Exclusivity Information
Isturisa holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Isturisa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 06, 2025 |
| Orphan Drug Exclusivity(ODE-286) | Mar 06, 2027 |
US patents provide insights into the exclusivity only within the United States, but Isturisa 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 Isturisa's family patents as well as insights into ongoing legal events on those patents.
Isturisa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Isturisa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 12, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Isturisa Generics:
There are no approved generic versions for Isturisa as of now.
About Isturisa
Isturisa is a drug owned by Recordati Rare Diseases Inc. It is used for treating Cushing's disease. Isturisa uses Osilodrostat Phosphate as an active ingredient. Isturisa was launched by Recordati Rare in 2020.
Approval Date:
Isturisa was approved by FDA for market use on 06 March, 2020.
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 Isturisa is 06 March, 2020, its NCE-1 date is estimated to be 06 March, 2024.
Active Ingredient:
Isturisa uses Osilodrostat Phosphate as the active ingredient. Check out other Drugs and Companies using Osilodrostat Phosphate ingredient
Treatment:
Isturisa is used for treating Cushing's disease.
Dosage:
Isturisa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 5MG BASE | TABLET | Prescription | ORAL |
| EQ 1MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE | TABLET | Discontinued | ORAL |