Ogsiveo is a drug owned by Springworks Therapeutics Inc. It is protected by 24 US drug patents filed from 2023 to 2024 out of which none have expired yet. Ogsiveo's patents will be open to challenges from 28 November, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be May 19, 2043. Details of Ogsiveo'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. | |||
| US10710966 | Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof |
Aug, 2039
(14 years from now) | Active |
| US11845732 | Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof |
Aug, 2039
(14 years from now) | Active |
| US10590087 | Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof |
Aug, 2039
(14 years from now) | Active |
| US10941118 | Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof |
Aug, 2039
(14 years from now) | Active |
| US7342118 | Imidazole compounds for the treatment of neurodegenerative disorders |
Aug, 2025
(8 months from now) | Active |
| US7795447 | Imidazole compounds for the treatment of neurodegenerative disorders |
Aug, 2025
(8 months from now) | Active |
| US7951958 | Imidazole compounds for the treatment of neurodegenerative disorders |
Mar, 2025
(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). | |||
| US12036207 | Treatments with nirogacestat |
May, 2043
(18 years from now) | Active |
| US11872211 | Treatments with nirogacestat |
May, 2043
(18 years from now) | Active |
| US12011435 | Treatments with nirogacestat |
May, 2043
(18 years from now) | Active |
| US12011434 | Treatments with nirogacestat |
May, 2043
(18 years from now) | Active |
| US11925620 | Treatments with nirogacestat |
May, 2043
(18 years from now) | Active |
| US11925619 | Treatments with nirogacestat |
May, 2043
(18 years from now) | Active |
| US11938116 | Treatments with nirogacestat |
May, 2043
(18 years from now) | Active |
| US11957662 | Treatments with nirogacestat |
May, 2043
(18 years from now) | Active |
| US11951096 | Treatments with nirogacestat |
May, 2043
(18 years from now) | Active |
| US11844780 | Chlorinated tetralin compounds and pharmaceutical compositions |
Sep, 2042
(17 years from now) | Active |
| US11807611 | Chlorinated tetralin compounds and pharmaceutical compositions |
Sep, 2042
(17 years from now) | Active |
| US11612588 | Chlorinated tetralin compounds and pharmaceutical compositions |
Jul, 2042
(17 years from now) | Active |
| US11504354 | Chlorinated tetralin compounds and pharmaceutical compositions |
Jul, 2042
(17 years from now) | Active |
| US11884635 | Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof |
Aug, 2039
(14 years from now) | Active |
| US11820748 | Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof |
Aug, 2039
(14 years from now) | Active |
| US11905255 | Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof |
Aug, 2039
(14 years from now) | Active |
| US11884634 | Compositions of solid forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4- tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide |
Aug, 2039
(14 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 Ogsiveo's patents.
Latest Legal Activities on Ogsiveo's Patents
Given below is the list of recent legal activities going on the following patents of Ogsiveo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Electronic Review Critical | 07 Jun, 2024 | US11951096 |
| Second letter to regulating agency to determine regulatory review period | 26 Apr, 2024 | US7342118 |
| Second letter to regulating agency to determine regulatory review period | 26 Apr, 2024 | US7795447 |
| Second letter to regulating agency to determine regulatory review period | 26 Apr, 2024 | US7951958 |
| Email Notification Critical | 17 Apr, 2024 | US11957662 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US7342118 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US7795447 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US7951958 |
| Mail Patent eGrant Notification | 16 Apr, 2024 | US11957662 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Apr, 2024 | US11957662 |
FDA has granted several exclusivities to Ogsiveo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ogsiveo, 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 Ogsiveo.
Exclusivity Information
Ogsiveo holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Ogsiveo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 27, 2028 |
| ODE*(ODE*) | Nov 27, 2030 |
| Orphan Drug Exclusivity(ODE-452) | Nov 27, 2030 |
US patents provide insights into the exclusivity only within the United States, but Ogsiveo 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 Ogsiveo's family patents as well as insights into ongoing legal events on those patents.
Ogsiveo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ogsiveo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 19, 2043 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ogsiveo Generics:
There are no approved generic versions for Ogsiveo as of now.
About Ogsiveo
Ogsiveo is a drug owned by Springworks Therapeutics Inc. It is used for treating adult patients with progressing desmoid tumors. Ogsiveo uses Nirogacestat Hydrobromide as an active ingredient. Ogsiveo was launched by Springworks in 2023.
Approval Date:
Ogsiveo was approved by FDA for market use on 27 November, 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 Ogsiveo is 27 November, 2023, its NCE-1 date is estimated to be 28 November, 2027.
Active Ingredient:
Ogsiveo uses Nirogacestat Hydrobromide as the active ingredient. Check out other Drugs and Companies using Nirogacestat Hydrobromide ingredient
Treatment:
Ogsiveo is used for treating adult patients with progressing desmoid tumors.
Dosage:
Ogsiveo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE | TABLET | Prescription | ORAL |
| EQ 150MG BASE | TABLET | Prescription | ORAL |