Valtoco is a drug owned by Neurelis Inc. It is protected by 7 US drug patents filed from 2020 to 2023. Out of these, 5 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 27, 2029. Details of Valtoco'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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11241414 | Administration of benzodiazepine compositions |
Mar, 2029
(3 years from now) | Active |
| US9763876 | Administration of benzodiazepine compositions |
Mar, 2029
(3 years from now) | Active |
| US11793786 | Administration of benzodiazepine compositions |
Mar, 2029
(3 years from now) | Active |
| US8895546 | Administration of benzodiazepine compositions |
Mar, 2029
(3 years from now) | Active |
| US8927497 | Absorption enhancers for intranasal administration |
Jul, 2025
(2 months from now) | Active |
| US9642913 | Pharmaceutical composition including alkyl glycoside and an anti-seizure agent |
May, 2025
(13 hours ago) |
Expired
|
| US10265402 | Absorption enhancers for drug administration |
May, 2025
(13 hours ago) |
Expired
|
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 Valtoco's patents.
Latest Legal Activities on Valtoco's Patents
Given below is the list of recent legal activities going on the following patents of Valtoco.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent eGrant | 24 Oct, 2023 | US11793786 |
| Patent eGrant Notification | 24 Oct, 2023 | US11793786 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Oct, 2023 | US11793786 |
| Recordation of Patent Grant Mailed Critical | 24 Oct, 2023 | US11793786 |
| Mail Patent eGrant Notification | 24 Oct, 2023 | US11793786 |
| Email Notification Critical | 24 Oct, 2023 | US11793786 |
| Email Notification Critical | 05 Oct, 2023 | US11793786 |
| Issue Notification Mailed Critical | 04 Oct, 2023 | US11793786 |
| Dispatch to FDC | 19 Sep, 2023 | US11793786 |
| Application Is Considered Ready for Issue Critical | 19 Sep, 2023 | US11793786 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Valtoco and ongoing litigations to help you estimate the early arrival of Valtoco generic.
Valtoco's Litigations
Valtoco been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 29, 2019, against patent number US9763876. The petitioner Aquestive Therapeutics, Inc. formerly Monosol RX, LLC, challenged the validity of this patent, with Neurelis, Inc. as the respondent. Click below to track the latest information on how companies are challenging Valtoco's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9763876 | January, 2019 |
FWD Entered
(06 Aug, 2020) | Neurelis, Inc. | Aquestive Therapeutics, Inc. formerly Monosol RX, LLC |
| US9763876 | January, 2019 |
Terminated-Denied
(01 Aug, 2019) | Neurelis, Inc. | Aquestive Therapeutics, Inc. formerly Monosol RX, LLC |
| US9763876 | January, 2019 |
Terminated-Denied
(01 Aug, 2019) | Neurelis, Inc. | Aquestive Therapeutics, Inc. formerly Monosol RX, LLC |
FDA has granted some exclusivities to Valtoco. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Valtoco, 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 Valtoco.
Exclusivity Information
Valtoco holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Valtoco's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jan 10, 2023 |
| Orphan Drug Exclusivity(ODE-279) | Jan 10, 2027 |
US patents provide insights into the exclusivity only within the United States, but Valtoco 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 Valtoco's family patents as well as insights into ongoing legal events on those patents.
Valtoco's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Valtoco's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 27, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Valtoco Generic API suppliers:
Diazepam is the generic name for the brand Valtoco. 35 different companies have already filed for the generic of Valtoco, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Valtoco's generic
Alternative Brands for Valtoco
Valtoco which is used for treating intermittent, stereotypic episodes of frequent seizure activity in patients 6 years of age and older., has several other brand drugs using the same active ingredient (Diazepam). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Aquestive |
| ||
| Bausch |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Diazepam, Valtoco's active ingredient. Check the complete list of approved generic manufacturers for Valtoco
About Valtoco
Valtoco is a drug owned by Neurelis Inc. It is used for treating intermittent, stereotypic episodes of frequent seizure activity in patients 6 years of age and older. Valtoco uses Diazepam as an active ingredient. Valtoco was launched by Neurelis Inc in 2020.
Approval Date:
Valtoco was approved by FDA for market use on 10 January, 2020.
Active Ingredient:
Valtoco uses Diazepam as the active ingredient. Check out other Drugs and Companies using Diazepam ingredient
Treatment:
Valtoco is used for treating intermittent, stereotypic episodes of frequent seizure activity in patients 6 years of age and older.
Dosage:
Valtoco is available in spray form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG/SPRAY | SPRAY | Prescription | NASAL |
| 7.5MG/SPRAY | SPRAY | Prescription | NASAL |
| 10MG/SPRAY | SPRAY | Prescription | NASAL |