Spravato is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 7 US drug patents filed from 2019 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 18, 2040. Details of Spravato'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). | |||
| US9592207 | Intranasal administration of ketamine to treat depression |
Mar, 2027
(2 years from now) | Active |
| US8785500 | Intranasal administration of ketamine to treat depression |
Mar, 2033
(8 years from now) | Active |
| US11446260 | Pharmaceutical composition of S-ketamine hydrochloride |
Mar, 2034
(9 years from now) | Active |
| US11173134 | Methods for the treatment of depression |
Sep, 2035
(11 years from now) | Active |
| US10869844 | Methods for the treatment of depression |
Sep, 2035
(11 years from now) | Active |
| US11311500 | Methods for the treatment of depression |
Sep, 2035
(11 years from now) | Active |
| US11883526 | Esketamine for the treatment of depression |
Feb, 2040
(15 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 Spravato's patents.
Latest Legal Activities on Spravato's Patents
Given below is the list of recent legal activities going on the following patents of Spravato.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Jun, 2024 | US10869844 |
| Email Notification | 30 Jan, 2024 | US11883526 |
| Recordation of Patent Grant Mailed | 30 Jan, 2024 | US11883526 |
| Patent Issue Date Used in PTA Calculation | 30 Jan, 2024 | US11883526 |
| Patent eGrant Notification | 30 Jan, 2024 | US11883526 |
| Recordation of Patent eGrant | 30 Jan, 2024 | US11883526 |
| Mail Patent eGrant Notification | 30 Jan, 2024 | US11883526 |
| Email Notification | 11 Jan, 2024 | US11883526 |
| Issue Notification Mailed | 10 Jan, 2024 | US11883526 |
| Dispatch to FDC | 20 Dec, 2023 | US11883526 |
FDA has granted several exclusivities to Spravato. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Spravato, 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 Spravato.
Exclusivity Information
Spravato holds 2 exclusivities. All of its exclusivities have expired in 2024. Details of Spravato's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-840) | Jul 31, 2023 |
| NCE*(NCE*) | Mar 05, 2024 |
US patents provide insights into the exclusivity only within the United States, but Spravato 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 Spravato's family patents as well as insights into ongoing legal events on those patents.
Spravato's family patents
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Generic Launch
Generic Release Date:
Spravato's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 18, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Spravato Generics:
There are no approved generic versions for Spravato as of now.
How can I launch a generic of Spravato before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Spravato's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Spravato's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Spravato -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 28 mg | 06 Mar, 2023 | 3 | 10 Sep, 2035 |
About Spravato
Spravato is a drug owned by Janssen Pharmaceuticals Inc. It is used for treatment-resistant depression in adults. Spravato uses Esketamine Hydrochloride as an active ingredient. Spravato was launched by Janssen Pharms in 2019.
Market Authorisation Date:
Spravato was approved by FDA for market use on 05 March, 2019.
Active Ingredient:
Spravato uses Esketamine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Esketamine Hydrochloride ingredient
Treatment:
Spravato is used for treatment-resistant depression in adults.
Dosage:
Spravato is available in spray form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 28MG BASE | SPRAY | Prescription | NASAL |