Kloxxado is a drug owned by Hikma Pharmaceuticals Usa Inc. It is protected by 6 US drug patents filed from 2021 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 26, 2034. Details of Kloxxado'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). | |||
| US11617713 | Liquid naloxone spray |
Aug, 2034
(9 years from now) | Active |
| US10973814 | Liquid naloxone spray |
Aug, 2034
(9 years from now) | Active |
| US10722510 | Liquid naloxone spray |
Aug, 2034
(9 years from now) | Active |
| US11975096 | Liquid naloxone spray |
Aug, 2034
(9 years from now) | Active |
| US11628139 | Liquid naloxone spray |
Aug, 2034
(9 years from now) | Active |
| US11135155 | Liquid naloxone spray |
Aug, 2034
(9 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 Kloxxado's patents.
Latest Legal Activities on Kloxxado's Patents
Given below is the list of recent legal activities going on the following patents of Kloxxado.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Jan, 2024 | US10722510 |
| Email Notification Critical | 19 May, 2023 | US11628139 |
| Electronic Review Critical | 19 May, 2023 | US11628139 |
| Miscellaneous Communication to Applicant - No Action Count | 18 May, 2023 | US11628139 |
| Mail Miscellaneous Communication to Applicant | 18 May, 2023 | US11628139 |
| Mail Miscellaneous Communication to Applicant | 21 Apr, 2023 | US11628139 |
| Electronic Review Critical | 21 Apr, 2023 | US11628139 |
| Email Notification Critical | 21 Apr, 2023 | US11628139 |
| Patent Issue Date Used in PTA Calculation Critical | 18 Apr, 2023 | US11628139 |
| Miscellaneous Communication to Applicant - No Action Count | 18 Apr, 2023 | US11628139 |
FDA has granted several exclusivities to Kloxxado. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kloxxado, 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 Kloxxado.
Exclusivity Information
Kloxxado holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Kloxxado's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 29, 2024 |
US patents provide insights into the exclusivity only within the United States, but Kloxxado 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 Kloxxado's family patents as well as insights into ongoing legal events on those patents.
Kloxxado's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Kloxxado's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 26, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kloxxado Generic API suppliers:
Naloxone Hydrochloride is the generic name for the brand Kloxxado. 29 different companies have already filed for the generic of Kloxxado, with Igi Labs Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Kloxxado's generic
How can I launch a generic of Kloxxado before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kloxxado's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kloxxado'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 Kloxxado -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 8 mg/spray | 30 Mar, 2023 | 1 | 26 Aug, 2034 |
Alternative Brands for Kloxxado
Kloxxado which is used for reversing the effects of opioid overdose in both adult and pediatric patients., has several other brand drugs using the same active ingredient (Naloxone Hydrochloride). 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 | |||
|---|---|---|---|---|
| Bdsi |
| |||
| Emergent |
| |||
| Harm Reduction Therp |
| |||
| Indivior |
| |||
| Kaleo Inc |
| |||
| Orexo Us Inc |
| |||
| Purdue Pharma Lp |
| |||
| Zmi Pharma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Naloxone Hydrochloride, Kloxxado's active ingredient. Check the complete list of approved generic manufacturers for Kloxxado
About Kloxxado
Kloxxado is a drug owned by Hikma Pharmaceuticals Usa Inc. It is used for reversing the effects of opioid overdose in both adult and pediatric patients. Kloxxado uses Naloxone Hydrochloride as an active ingredient. Kloxxado was launched by Hikma in 2021.
Can you believe Kloxxado received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Kloxxado was approved by FDA for market use on 29 April, 2021.
Active Ingredient:
Kloxxado uses Naloxone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Naloxone Hydrochloride ingredient
Treatment:
Kloxxado is used for reversing the effects of opioid overdose in both adult and pediatric patients.
Dosage:
Kloxxado is available in spray form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 8MG/SPRAY | SPRAY | Prescription | NASAL |