Epipen is a drug owned by Mylan Specialty Lp. It is protected by 5 US drug patents filed from 2013 to 2017 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 11, 2025. Details of Epipen'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). | |||
| US7449012 | Automatic injector |
Sep, 2025
(8 months from now) | Active |
| US8048035 | Automatic injector with needle cover |
Sep, 2025
(8 months from now) | Active |
| US9586010 | Automatic injector with needle cover |
Sep, 2025
(8 months from now) | Active |
| US8870827 | Automatic injector |
Sep, 2025
(8 months from now) | Active |
| US7794432 | Automatic injector with kickback attenuation |
Sep, 2025
(8 months 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 Epipen's patents.
Latest Legal Activities on Epipen's Patents
Given below is the list of recent legal activities going on the following patents of Epipen.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Apr, 2023 | US8048035 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Apr, 2022 | US8870827 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 Mar, 2022 | US7794432 (Litigated) |
| Email Notification Critical | 07 May, 2021 | US9586010 |
| Change in Power of Attorney (May Include Associate POA) Critical | 07 May, 2021 | US9586010 |
| Correspondence Address Change Critical | 06 May, 2021 | US9586010 |
| Email Notification Critical | 05 May, 2021 | US7794432 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 May, 2021 | US8870827 |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 May, 2021 | US7449012 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 May, 2021 | US7794432 (Litigated) |
Several oppositions have been filed on Epipen's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Epipen's generic, the next section provides detailed information on ongoing and past EP oppositions related to Epipen patents.
Epipen's Oppositions Filed in EPO
Epipen has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 07, 2014, by Alk-Abello A/S. This opposition was filed on patent number EP10194414A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10155967A | Jan, 2021 | Keilitz Haines & Partner Patentanwälte PartGmbB | Granted and Under Opposition |
| EP10155967A | Apr, 2020 | ALK-ABELLO A/S | Granted and Under Opposition |
| EP05783727A | Nov, 2016 | ALK-ABELLO A/S | Revoked |
| EP05783727A | Nov, 2016 | Merck Patent GmbH | Revoked |
| EP05783727A | Oct, 2016 | Meridian Medical Technologies, Inc. | Revoked |
| EP09173753A | Jul, 2016 | Merck Patent GmbH | Patent maintained as amended |
| EP10194414A | Feb, 2015 | Feldmeier, Jürgen | Revoked |
| EP10194414A | Nov, 2014 | ALK-ABELLO A/S | Revoked |
US patents provide insights into the exclusivity only within the United States, but Epipen 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 Epipen's family patents as well as insights into ongoing legal events on those patents.
Epipen's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Epipen's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 11, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Epipen Generic API suppliers:
Epinephrine is the generic name for the brand Epipen. 4 different companies have already filed for the generic of Epipen, with Am Regent having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Epipen's generic
How can I launch a generic of Epipen before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Epipen's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Epipen'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 Epipen -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | 20 Jul, 2009 | 1 | 16 Aug, 2018 | 11 Sep, 2025 | Deferred |
Alternative Brands for Epipen
There are several other brand drugs using the same active ingredient (Epinephrine) as Epipen. 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 |
| |||
| Ars Pharms Operation |
| |||
| Baxter Hlthcare Corp |
| |||
| Bpi Labs |
| |||
| Endo Operations |
| |||
| Impax |
| |||
| Inforlife |
| |||
| Kaleo Inc |
| |||
| Long Grove Pharms |
| |||
| Mylan Speciality Lp |
| |||
| Vyteris |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Epinephrine, Epipen's active ingredient. Check the complete list of approved generic manufacturers for Epipen
About Epipen
Epipen is a drug owned by Mylan Specialty Lp. Epipen uses Epinephrine as an active ingredient. Epipen was launched by Mylan Speciality Lp in 1995.
Approval Date:
Epipen was approved by FDA for market use on 03 August, 1995.
Active Ingredient:
Epipen uses Epinephrine as the active ingredient. Check out other Drugs and Companies using Epinephrine ingredient
Dosage:
Epipen is available in injectable form for intramuscular, subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.3MG/DELIVERY | INJECTABLE | Prescription | INTRAMUSCULAR, SUBCUTANEOUS |