Pemfexy is a drug owned by Eagle Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2020 to 2025. Out of these, 3 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 19, 2036. Details of Pemfexy's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9604990 | Crystalline forms of pemetrexed diacid and manufacturing processes therefor |
Oct, 2035
(9 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11793813 | Pemetrexed formulations |
Feb, 2036
(9 years from now) | Active |
| US12115164 | Pemetrexed Formulations |
Feb, 2036
(9 years from now) | Active |
| US7772209 | Antifolate combination therapies |
May, 2022
(4 years 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 Pemfexy's patents.
Latest Legal Activities on Pemfexy's Patents
Given below is the list of recent legal activities going on the following patents of Pemfexy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eGrant Notification | 15 Oct, 2024 | US12115164 |
| Recordation of Patent eGrant | 15 Oct, 2024 | US12115164 |
| Patent Issue Date Used in PTA Calculation | 15 Oct, 2024 | US12115164 |
| Recordation of Patent Grant Mailed | 15 Oct, 2024 | US12115164 |
| Mail Patent eGrant Notification | 15 Oct, 2024 | US12115164 |
| Email Notification | 15 Oct, 2024 | US12115164 |
| Issue Notification Mailed | 25 Sep, 2024 | US12115164 |
| Email Notification | 25 Sep, 2024 | US12115164 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Sep, 2024 | US9604990 |
| Application Is Considered Ready for Issue | 15 Aug, 2024 | US12115164 |
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 Pemfexy and ongoing
litigations to
help you estimate the early arrival of Pemfexy generic.
Pemfexy's Litigations
Pemfexy been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 14, 2013, against patent number US7772209. The petitioner Accord Healthcare, Inc., USA, challenged the validity of this patent, with Eli Lilly and Company as the respondent. Click below to track the latest information on how companies are challenging Pemfexy's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7772209 | November, 2015 |
Final Written Decision
(05 Oct, 2017) | Eli Lilly and Company | Neptune Generics, LLC et al. |
| US7772209 | December, 2015 |
Final Written Decision
(05 Oct, 2017) | Eli Lilly and Company | Sandoz Inc. |
| US7772209 | June, 2016 |
Final Written Decision
(05 Oct, 2017) | Eli Lilly and Company | Wockhardt Bio AG et al. |
| US7772209 | July, 2016 |
Final Written Decision
(05 Oct, 2017) | Eli Lilly and Company | Apotex Inc. et al. |
| US7772209 | July, 2016 |
Final Written Decision
(05 Oct, 2017) | Eli Lilly and Company | Teva Pharmaceuticals USA, Inc. et al. |
| US7772209 | July, 2016 |
Final Written Decision
(05 Oct, 2017) | Eli Lilly and Company | Wockhardt Bio AG et al. |
| US7772209 | July, 2016 |
Final Written Decision
(05 Oct, 2017) | Eli Lilly and Company | Apotex Inc. et al. |
| US7772209 | June, 2013 |
Institution Denied
(01 Oct, 2013) | Eli Lilly and Company | Accord Healthcare, Inc., USA |
Several oppositions have been filed on Pemfexy'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 Pemfexy's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Pemfexy patents.
Pemfexy's Oppositions Filed in EPO
Pemfexy has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 17, 2008, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP01948214A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP01948214A | Oct, 2012 | Actavis Deutschland GmbH & Co. KG | Opposition rejected |
| EP01948214A | Jan, 2008 | Teva Pharmaceutical Industries Ltd. | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but
Pemfexy 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 Pemfexy's family patents as well as insights into
ongoing legal events
on those patents.
Pemfexy's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Pemfexy:
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:
Pemfexy's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 19, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pemfexy Generics:
There are no approved generic versions for Pemfexy as of now.
Alternative Brands for Pemfexy
Pemfexy which is used for the treatment of non-squamous non-small cell lung cancer in patients receiving pemetrexed along with vitamin B12 and folic acid supplementation., has several other brand drugs using the same active ingredient (Pemetrexed). 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 | |
|---|---|---|
| Avyxa Holdings |
| |
| Lilly |
| |
| Shilpa |
|
About Pemfexy
Pemfexy is a drug owned by Eagle Pharmaceuticals Inc. It is used for the treatment of non-squamous non-small cell lung cancer in patients receiving pemetrexed along with vitamin B12 and folic acid supplementation. Pemfexy uses Pemetrexed as an active ingredient. Pemfexy was launched by Eagle in 2020.
Approval Date:
Pemfexy was approved by FDA for market use on 08 February, 2020.
Active Ingredient:
Pemfexy uses Pemetrexed as the active ingredient. Check out other Drugs and Companies using Pemetrexed ingredient
Treatment:
Pemfexy is used for the treatment of non-squamous non-small cell lung cancer in patients receiving pemetrexed along with vitamin B12 and folic acid supplementation.
Dosage:
Pemfexy is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG/20ML (25MG/ML) | SOLUTION | Prescription | INTRAVENOUS |