Inpefa is a drug owned by Lexicon Pharmaceuticals Inc. It is protected by 3 US drug patents filed in 2023 out of which none have expired yet. Inpefa's patents will be open to challenges from 27 May, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 07, 2030. Details of Inpefa'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. | |||
| US8217156 | Solid forms of (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol and methods of their use |
Oct, 2030
(5 years from now) | Active |
| US8476413 | Sulfanyl-tetrahydropyran-based compounds and methods of their use |
May, 2028
(3 years from now) | Active |
| US7781577 | Inhibitors of sodium glucose co-transporter 2 and methods of their use |
May, 2028
(3 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 Inpefa's patents.
Latest Legal Activities on Inpefa's Patents
Given below is the list of recent legal activities going on the following patents of Inpefa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 07 Feb, 2024 | US8217156 |
| Second letter to regulating agency to determine regulatory review period | 07 Feb, 2024 | US7781577 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US7781577 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US8217156 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 Jan, 2024 | US8217156 |
| Initial letter Re: PTE Application to regulating agency | 08 Aug, 2023 | US7781577 |
| Initial letter Re: PTE Application to regulating agency | 08 Aug, 2023 | US8217156 |
| Change in Power of Attorney (May Include Associate POA) Critical | 25 Jul, 2023 | US7781577 |
| Email Notification Critical | 25 Jul, 2023 | US7781577 |
| Change in Power of Attorney (May Include Associate POA) Critical | 25 Jul, 2023 | US8217156 |
FDA has granted several exclusivities to Inpefa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Inpefa, 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 Inpefa.
Exclusivity Information
Inpefa holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Inpefa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 26, 2028 |
US patents provide insights into the exclusivity only within the United States, but Inpefa 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 Inpefa's family patents as well as insights into ongoing legal events on those patents.
Inpefa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Inpefa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 07, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Inpefa Generics:
There are no approved generic versions for Inpefa as of now.
About Inpefa
Inpefa is a drug owned by Lexicon Pharmaceuticals Inc. It is used for reducing the risk of cardiovascular events in adults with heart failure, type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors. Inpefa uses Sotagliflozin as an active ingredient. Inpefa was launched by Lexicon Pharms Inc in 2023.
Approval Date:
Inpefa was approved by FDA for market use on 26 May, 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 Inpefa is 26 May, 2023, its NCE-1 date is estimated to be 27 May, 2027.
Active Ingredient:
Inpefa uses Sotagliflozin as the active ingredient. Check out other Drugs and Companies using Sotagliflozin ingredient
Treatment:
Inpefa is used for reducing the risk of cardiovascular events in adults with heart failure, type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.
Dosage:
Inpefa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | TABLET | Prescription | ORAL |
| 400MG | TABLET | Prescription | ORAL |