Epipen Jr. is a drug owned by Viatris Specialty Llc. It is protected by 5 US drug patents filed from 2013 to 2017 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 11, 2025. Details of Epipen Jr.'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). | |||
| US9586010 | Automatic injector with needle cover |
Sep, 2025
(1 year, 24 days ago) |
Expired
|
| US7449012 | Automatic injector |
Sep, 2025
(1 year, 24 days ago) |
Expired
|
| US7794432 | Automatic injector with kickback attenuation |
Sep, 2025
(1 year, 24 days ago) |
Expired
|
| US8048035 | Automatic injector with needle cover |
Sep, 2025
(1 year, 24 days ago) |
Expired
|
| US8870827 | Automatic injector |
Sep, 2025
(1 year, 24 days ago) |
Expired
|
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 Jr.'s patents.
Latest Legal Activities on Epipen Jr.'s Patents
Given below is the list of recent legal activities going on the following patents of Epipen Jr..
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Aug, 2024 | US9586010 |
| 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) |
| Change in Power of Attorney (May Include Associate POA)
Critical | 07 May, 2021 | US9586010 |
| Email Notification
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) |
Several oppositions have been filed on Epipen Jr.'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 Jr.'s generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Epipen Jr. patents.
Epipen Jr.'s Oppositions Filed in EPO
Epipen Jr. 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 Jr. 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 Jr.'s family patents as well as insights into
ongoing legal events
on those patents.
Epipen Jr.'s Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Epipen Jr.:
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:
Epipen Jr.'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 Jr. Generic API suppliers:
Epinephrine is the generic name for the brand Epipen Jr.. 9 different companies have already filed for the generic of Epipen Jr., with Gland having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Epipen Jr.'s generic
How can I launch a generic of Epipen Jr. before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Epipen Jr.'s patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Epipen Jr.'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 Jr. -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 20 Jul, 2009 | 11 Sep, 2025 | Deferred | 16 Aug, 2018 | Less |
Alternative Brands for Epipen Jr.
Epipen Jr. which is used for treating high blood pressure, heart failure, and reducing the risk of heart attacks., has several other brand drugs using the same active ingredient (Epinephrine). 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 |
| ||
| 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, Epipen Jr.'s active ingredient. Check the complete list of approved generic manufacturers for Epipen Jr.
About Epipen Jr.
Epipen Jr. is a drug owned by Viatris Specialty Llc. It is used for treating high blood pressure, heart failure, and reducing the risk of heart attacks. Epipen Jr. uses Epinephrine as an active ingredient. Epipen Jr. was launched by Viatris in 1987.
Approval Date:
Epipen Jr. was approved by FDA for market use on 22 December, 1987.
Active Ingredient:
Epipen Jr. uses Epinephrine as the active ingredient. Check out other Drugs and Companies using Epinephrine ingredient
Treatment:
Epipen Jr. is used for treating high blood pressure, heart failure, and reducing the risk of heart attacks.
Dosage:
Epipen Jr. is available in injectable form for intramuscular, subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.15MG/DELIVERY | INJECTABLE | Prescription | INTRAMUSCULAR, SUBCUTANEOUS |