Sezaby is a drug owned by Sun Pharmaceutical Industries Inc. It is protected by 1 US drug patent filed in 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 07, 2042. Details of Sezaby'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11857683 | Stabilization of phenobarbital sodium for injection |
Apr, 2042
(17 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 Sezaby's patents.
Latest Legal Activities on Sezaby's Patents
Given below is the list of recent legal activities going on the following patents of Sezaby.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Patent eGrant Notification | 02 Jan, 2024 | US11857683 |
| Mail Patent eGrant Notification | 02 Jan, 2024 | US11857683 |
| Email Notification | 02 Jan, 2024 | US11857683 |
| Recordation of Patent Grant Mailed | 02 Jan, 2024 | US11857683 |
| Recordation of Patent eGrant | 02 Jan, 2024 | US11857683 |
| Patent Issue Date Used in PTA Calculation | 02 Jan, 2024 | US11857683 |
| Email Notification | 14 Dec, 2023 | US11857683 |
| Issue Notification Mailed | 13 Dec, 2023 | US11857683 |
| Application Is Considered Ready for Issue | 29 Nov, 2023 | US11857683 |
| Dispatch to FDC | 29 Nov, 2023 | US11857683 |
FDA has granted several exclusivities to Sezaby. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sezaby, 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 Sezaby.
Exclusivity Information
Sezaby holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Sezaby's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE-414) | Nov 17, 2029 |
US patents provide insights into the exclusivity only within the United States, but Sezaby 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 Sezaby's family patents as well as insights into ongoing legal events on those patents.
Sezaby's family patents
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Generic Launch
Generic Release Date:
Sezaby's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 07, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sezaby Generics:
There are no approved generic versions for Sezaby as of now.
About Sezaby
Sezaby is a drug owned by Sun Pharmaceutical Industries Inc. It is used for treating neonatal seizures. Sezaby uses Phenobarbital Sodium as an active ingredient. Sezaby was launched by Sun Pharm Inds Inc in 2022.
Market Authorisation Date:
Sezaby was approved by FDA for market use on 17 November, 2022.
Active Ingredient:
Sezaby uses Phenobarbital Sodium as the active ingredient. Check out other Drugs and Companies using Phenobarbital Sodium ingredient
Treatment:
Sezaby is used for treating neonatal seizures.
Dosage:
Sezaby is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/VIAL | POWDER | Prescription | INTRAVENOUS |