Sohonos is a drug owned by Ipsen Biopharmaceuticals Inc. It is protected by 6 US drug patents filed from 2023 to 2024 out of which none have expired yet. Sohonos's patents will be open to challenges from 17 August, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 08, 2037. Details of Sohonos'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). | |||
| US10864194 | Methods for treating heterotopic ossification |
Jun, 2037
(12 years from now) | Active |
| US11622959 | Methods for treating heterotopic ossification |
Jun, 2037
(12 years from now) | Active |
| US9314439 | Composition and method for muscle repair and regeneration |
Aug, 2031
(6 years from now) | Active |
| US12023312 | Composition and method for muscle repair and regeneration |
Aug, 2031
(6 years from now) | Active |
| US10292954 | Composition and method for muscle repair and regeneration |
Aug, 2031
(6 years from now) | Active |
| US9789074 | Composition and method for muscle repair and regeneration |
Aug, 2031
(6 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 Sohonos's patents.
Latest Legal Activities on Sohonos's Patents
Given below is the list of recent legal activities going on the following patents of Sohonos.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 May, 2024 | US10864194 |
| Second letter to regulating agency to determine regulatory review period | 14 Mar, 2024 | US9314439 |
| Second letter to regulating agency to determine regulatory review period | 14 Mar, 2024 | US10292954 |
| Second letter to regulating agency to determine regulatory review period | 14 Mar, 2024 | US11622959 |
| Second letter to regulating agency to determine regulatory review period | 14 Mar, 2024 | US10864194 |
| Letter from FDA or Dept of Agriculture re PTE application | 06 Feb, 2024 | US11622959 |
| Letter from FDA or Dept of Agriculture re PTE application | 06 Feb, 2024 | US10864194 |
| Letter from FDA or Dept of Agriculture re PTE application | 06 Feb, 2024 | US10292954 |
| Letter from FDA or Dept of Agriculture re PTE application | 06 Feb, 2024 | US9314439 |
| Initial letter Re: PTE Application to regulating agency | 22 Nov, 2023 | US10292954 |
FDA has granted several exclusivities to Sohonos. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sohonos, 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 Sohonos.
Exclusivity Information
Sohonos holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Sohonos's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 16, 2028 |
| Orphan Drug Exclusivity(ODE-439) | Aug 16, 2030 |
US patents provide insights into the exclusivity only within the United States, but Sohonos 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 Sohonos's family patents as well as insights into ongoing legal events on those patents.
Sohonos's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sohonos's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 08, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sohonos Generics:
There are no approved generic versions for Sohonos as of now.
About Sohonos
Sohonos is a drug owned by Ipsen Biopharmaceuticals Inc. It is used for reducing heterotopic ossification in patients with fibrodysplasia (myositis) ossificans progressiva. Sohonos uses Palovarotene as an active ingredient. Sohonos was launched by Ipsen in 2023.
Approval Date:
Sohonos was approved by FDA for market use on 16 August, 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 Sohonos is 16 August, 2023, its NCE-1 date is estimated to be 17 August, 2027.
Active Ingredient:
Sohonos uses Palovarotene as the active ingredient. Check out other Drugs and Companies using Palovarotene ingredient
Treatment:
Sohonos is used for reducing heterotopic ossification in patients with fibrodysplasia (myositis) ossificans progressiva.
Dosage:
Sohonos is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.5MG | CAPSULE | Prescription | ORAL |
| 1MG | CAPSULE | Prescription | ORAL |
| 10MG | CAPSULE | Prescription | ORAL |
| 5MG | CAPSULE | Prescription | ORAL |
| 2.5MG | CAPSULE | Prescription | ORAL |