Ogsiveo Patent Expiration

Ogsiveo is a drug owned by Springworks Therapeutics Inc. It is protected by 26 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.
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
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
US7795447 Imidazole compounds for the treatment of neurodegenerative disorders
Aug, 2025

(8 months from now)

Active
US7342118 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

(2 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).
US11957662 Treatments with nirogacestat
May, 2043

(18 years from now)

Active
US12011435 Treatments with nirogacestat
May, 2043

(18 years from now)

Active
US11925619 Treatments with nirogacestat
May, 2043

(18 years from now)

Active
US12036207 Treatments with nirogacestat
May, 2043

(18 years from now)

Active
US11872211 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
US11938116 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
US12110277 Synthesis of nirogacestat
Jul, 2042

(17 years from now)

Active
US11504354 Chlorinated tetralin compounds and pharmaceutical compositions
Jul, 2042

(17 years from now)

Active
US11612588 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
US12116347 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.

Given below is the list of recent legal activities going on the following patents of Ogsiveo.

Activity Date Patent Number
Patent litigations
Electronic Review 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 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 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

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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


Family Patents

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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 150MG BASE TABLET Prescription ORAL
EQ 100MG BASE TABLET Prescription ORAL
EQ 50MG BASE TABLET Prescription ORAL