Neffy is a drug owned by Ars Pharmaceuticals Operations Inc. It is protected by 8 US drug patents filed from 2024 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 06, 2039. Details of Neffy'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). | |||
| US12324838 | Intranasal epinephrine formulations and methods for the treatment of disease |
Feb, 2039
(12 years from now) | Active |
| US11191838 | Intranasal epinephrine formulations and methods for the treatment of disease |
Feb, 2039
(12 years from now) | Active |
| US11918655 | Intranasal epinephrine formulations and methods for the treatment of disease |
Feb, 2039
(12 years from now) | Active |
| US11744895 | Intranasal epinephrine formulations and methods for the treatment of disease |
Feb, 2039
(12 years from now) | Active |
| US11717571 | Intranasal epinephrine formulations and methods for the treatment of disease |
Feb, 2039
(12 years from now) | Active |
| US10682414 | Intranasal epinephrine formulations and methods for the treatment of disease |
Feb, 2039
(12 years from now) | Active |
| US10576156 | Compositions for drug administration |
Feb, 2038
(11 years from now) | Active |
| US11173209 | Compositions for drug administration |
Feb, 2038
(11 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 Neffy's patents.
Latest Legal Activities on Neffy's Patents
Given below is the list of recent legal activities going on the following patents of Neffy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed | 17 Jun, 2025 | US12324838 |
| Email Notification | 10 Jun, 2025 | US12324838 |
| Recordation of Patent eGrant | 10 Jun, 2025 | US12324838 |
| Patent eGrant Notification | 10 Jun, 2025 | US12324838 |
| Patent Issue Date Used in PTA Calculation | 10 Jun, 2025 | US12324838 |
| Mail Patent eGrant Notification | 10 Jun, 2025 | US12324838 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Jun, 2025 | US11191838 |
| Email Notification | 31 May, 2025 | US12324838 |
| Issue Notification Mailed | 28 May, 2025 | US12324838 |
| Application Is Considered Ready for Issue | 09 May, 2025 | US12324838 |
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 Neffy and ongoing
litigations to
help you estimate the early arrival of Neffy generic.
Neffy's Litigations
Neffy been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 12, 2021, against patent number US10682414. The petitioner Amphastar Pharmaceuticals, Inc., challenged the validity of this patent, with Aegis Therapeutics, LLC et al. as the respondent. Click below to track the latest information on how companies are challenging Neffy's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10682414 | August, 2021 |
Final Written Decision
(09 Feb, 2023) | Aegis Therapeutics, LLC et al. | Amphastar Pharmaceuticals, Inc. |
US patents provide insights into the exclusivity only within the United States, but
Neffy 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 Neffy's family patents as well as insights into
ongoing legal events
on those patents.
Neffy's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Neffy:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Neffy's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 06, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Neffy Generic API suppliers:
Epinephrine is the generic name for the brand Neffy. 9 different companies have already filed for the generic of Neffy, with Gland having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Neffy's generic
How can I launch a generic of Neffy before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Neffy's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Neffy'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 Neffy -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 29 Dec, 2025 | 06 Feb, 2039 | Less | |||
| 30 Jun, 2025 | 06 Feb, 2039 | Less |
Alternative Brands for Neffy
There are several other brand drugs using the same active ingredient (Epinephrine) as Neffy. 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 | ||
|---|---|---|---|
| Adamis Pharms Corp |
| ||
| Armstrong Pharms |
| ||
| Baxter Hlthcare Corp |
| ||
| Bpi Labs |
| ||
| Fresenius Kabi Usa |
| ||
| Impax |
| ||
| Inforlife |
| ||
| Kaleo Inc |
| ||
| Long Grove Pharms |
| ||
| Ph Health |
| ||
| Viatris |
| ||
| Vyteris |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Epinephrine, Neffy's active ingredient. Check the complete list of approved generic manufacturers for Neffy
About Neffy
Neffy is a drug owned by Ars Pharmaceuticals Operations Inc. Neffy uses Epinephrine as an active ingredient. Neffy was launched by Ars Operation in 2025.
Approval Date:
Neffy was approved by FDA for market use on 05 March, 2025.
Active Ingredient:
Neffy uses Epinephrine as the active ingredient. Check out other Drugs and Companies using Epinephrine ingredient
Dosage:
Neffy is available in spray form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG/SPRAY | SPRAY | Prescription | NASAL |
| 1MG/SPRAY | SPRAY | Prescription | NASAL |