Narcan is a drug owned by Emergent Operations Ireland Ltd. It is protected by 8 US drug patents filed from 2015 to 2018 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 16, 2035. Details of Narcan'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). | |||
| US9629965 | Nasal drug products and methods of their use |
Mar, 2035
(10 years from now) | Active |
| US10085937 | Nasal drug products and methods of their use |
Mar, 2035
(10 years from now) | Active |
| US9561177 | Nasal drug products and methods of their use |
Mar, 2035
(10 years from now) | Active |
| US9468747 | Nasal drug products and methods of their use |
Mar, 2035
(10 years from now) | Active |
| US9211253 | Nasal drug products and methods of their use |
Mar, 2035
(10 years from now) | Active |
| US9775838 | Nasal drug products and methods of their use |
Mar, 2035
(10 years from now) | Active |
| US9480644 | Nasal drug products and methods of their use |
Mar, 2035
(10 years from now) | Active |
| US9707226 | Nasal drug products and methods of their use |
Mar, 2035
(10 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 Narcan's patents.
Latest Legal Activities on Narcan's Patents
Given below is the list of recent legal activities going on the following patents of Narcan.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Apr, 2024 | US9480644 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 31 May, 2023 | US9211253 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Mar, 2022 | US10085937 |
| Review Certificate Mailed | 24 Aug, 2021 | US9629965 |
| Review Certificate Mailed | 23 Aug, 2021 | US9211253 (Litigated) |
| Review Certificate | 05 Aug, 2021 | US9629965 |
| Review Certificate | 05 Aug, 2021 | US9211253 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Mar, 2021 | US9775838 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Jan, 2021 | US9707226 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Sep, 2020 | US9629965 |
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 Narcan and ongoing litigations to help you estimate the early arrival of Narcan generic.
Narcan's Litigations
Narcan been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 19, 2019, against patent number US9561177. The petitioner Nalox-1 Pharmaceuticals, LLC et al., challenged the validity of this patent, with Opiant Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Narcan's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9211253 | February, 2019 |
Final Written Decision
(21 Aug, 2020) | Opiant Pharmaceuticals, Inc. | Nalox-1 Pharmaceuticals, LLC et al. |
| US9468747 | February, 2019 |
Final Written Decision
(21 Aug, 2020) | Opiant Pharmaceuticals, Inc. | Nalox-1 Pharmaceuticals, LLC et al. |
| US9629965 | February, 2019 |
Final Written Decision
(21 Aug, 2020) | Opiant Pharmaceuticals, Inc. | Nalox-1 Pharmaceuticals, LLC et al. |
| US9775838 | February, 2019 |
Institution Denied
(16 Oct, 2019) | Opiant Pharmaceuticals, Inc. | Nalox-1 Pharmaceuticals, LLC et al. |
| US9629965 | February, 2019 |
Institution Denied
(01 Oct, 2019) | Opiant Pharmaceuticals, Inc. | Nalox-1 Pharmaceuticals, LLC et al. |
| US9468747 | February, 2019 |
Institution Denied
(09 Sep, 2019) | Opiant Pharmaceuticals, Inc. | Nalox-1 Pharmaceuticals, LLC et al. |
| US9211253 | February, 2019 |
Institution Denied
(27 Aug, 2019) | Opiant Pharmaceuticals, Inc. | Nalox-1 Pharmaceuticals, LLC et al. |
| US9561177 | February, 2019 |
Institution Denied
(27 Aug, 2019) | Opiant Pharmaceuticals, Inc. | Nalox-1 Pharmaceuticals, LLC et al. |
US patents provide insights into the exclusivity only within the United States, but Narcan 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 Narcan's family patents as well as insights into ongoing legal events on those patents.
Narcan's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Narcan's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 16, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Narcan Generic API suppliers:
Naloxone Hydrochloride is the generic name for the brand Narcan. 29 different companies have already filed for the generic of Narcan, with Igi Labs Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Narcan's generic
How can I launch a generic of Narcan before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Narcan's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Narcan'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 Narcan -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2 mg/spray | 28 Dec, 2017 | 1 | 16 Mar, 2035 | ||
| 4 mg/spray | 15 Jul, 2016 | 1 | 19 Apr, 2019 | 16 Mar, 2035 | Eligible |
Alternative Brands for Narcan
Narcan which is used for the emergency treatment of opioid overdose to reverse respiratory and central nervous system depression., 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 |
| |||
| Harm Reduction Therp |
| |||
| Hikma |
| |||
| 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, Narcan's active ingredient. Check the complete list of approved generic manufacturers for Narcan
About Narcan
Narcan is a drug owned by Emergent Operations Ireland Ltd. It is used for the emergency treatment of opioid overdose to reverse respiratory and central nervous system depression. Narcan uses Naloxone Hydrochloride as an active ingredient. Narcan was launched by Emergent in 2017.
Approval Date:
Narcan was approved by FDA for market use on 24 January, 2017.
Active Ingredient:
Narcan uses Naloxone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Naloxone Hydrochloride ingredient
Treatment:
Narcan is used for the emergency treatment of opioid overdose to reverse respiratory and central nervous system depression.
Dosage:
Narcan is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG/SPRAY | SPRAY, METERED | Over the counter | NASAL |
| 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED | Discontinued | NASAL |