Epipen Patent Expiration

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

(10 months from now)

Active
US8048035 Automatic injector with needle cover
Sep, 2025

(10 months from now)

Active
US9586010 Automatic injector with needle cover
Sep, 2025

(10 months from now)

Active
US8870827 Automatic injector
Sep, 2025

(10 months from now)

Active
US7794432 Automatic injector with kickback attenuation
Sep, 2025

(10 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.

Given below is the list of recent legal activities going on the following patents of Epipen.

Activity Date Patent Number
Patent litigations
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 07 May, 2021 US9586010
Change in Power of Attorney (May Include Associate POA) 07 May, 2021 US9586010
Correspondence Address Change 06 May, 2021 US9586010
Email Notification 05 May, 2021 US7794432 (Litigated)
Change in Power of Attorney (May Include Associate POA) 05 May, 2021 US8870827
Change in Power of Attorney (May Include Associate POA) 05 May, 2021 US7449012 (Litigated)
Change in Power of Attorney (May Include Associate POA) 05 May, 2021 US7794432 (Litigated)

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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
Patent litigations
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

Epipen has patent protection in a total of 18 countries. It's US patent count contributes only to 28.8% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Epipen.

Family Patents

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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 Generics:

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.


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