Alimta is a drug owned by Eli Lilly And Co. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 24, 2022. Details of Alimta'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). | |||
|
US7772209 (Pediatric) | Antifolate combination therapies |
May, 2022
(2 years ago) |
Expired
|
| US7772209 | Antifolate combination therapies |
Nov, 2021
(3 years ago) |
Expired
|
|
US5344932 (Pediatric) | N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-glutamic acid derivatives |
Jan, 2017
(8 years ago) |
Expired
|
| US5344932 | N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-glutamic acid derivatives |
Jul, 2016
(8 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 Alimta's patents.
Latest Legal Activities on Alimta's Patents
Given below is the list of recent legal activities going on the following patents of Alimta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 12 Sep, 2022 | US7772209 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 28 Mar, 2022 | US7772209 (Litigated) |
| Review Certificate Mailed | 26 Sep, 2019 | US7772209 (Litigated) |
| Review Certificate | 06 Sep, 2019 | US7772209 (Litigated) |
| Termination or Final Written Decision | 05 Oct, 2017 | US7772209 (Litigated) |
| Request for Trial Granted Critical | 02 Dec, 2016 | US7772209 (Litigated) |
| Request for Trial Granted Critical | 21 Nov, 2016 | US7772209 (Litigated) |
| Request for Trial Granted Critical | 06 Oct, 2016 | US7772209 (Litigated) |
| Request for Trial Granted Critical | 04 Oct, 2016 | US7772209 (Litigated) |
| Request for Trial Granted Critical | 30 Sep, 2016 | US7772209 (Litigated) |
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 Alimta and ongoing litigations to help you estimate the early arrival of Alimta generic.
Alimta's Litigations
Alimta 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 Alimta's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7772209 | November, 2015 |
FWD Entered
(05 Oct, 2017) | Eli Lilly and Company | Neptune Generics, LLC |
| US7772209 | December, 2015 |
FWD Entered
(05 Oct, 2017) | Eli Lilly and Company | Sandoz Inc. |
| US7772209 | June, 2016 |
FWD Entered
(05 Oct, 2017) | Eli Lilly and Company | Wockhardt Bio AG |
| US7772209 | July, 2016 |
FWD Entered
(05 Oct, 2017) | Eli Lilly and Company | Apotex Inc. |
| US7772209 | July, 2016 |
FWD Entered
(05 Oct, 2017) | Eli Lilly and Company | Teva Pharmaceuticals USA, Inc. |
| US7772209 | July, 2016 |
FWD Entered
(05 Oct, 2017) | Eli Lilly and Company | Wockhardt Bio AG |
| US7772209 | July, 2016 |
FWD Entered
(05 Oct, 2017) | Eli Lilly and Company | Apotex Inc. |
| US7772209 | June, 2013 |
Terminated-Denied
(01 Oct, 2013) | Eli Lilly and Company | Accord Healthcare, Inc., USA |
FDA has granted some exclusivities to Alimta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Alimta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Alimta.
Exclusivity Information
Alimta holds 5 exclusivities. All of its exclusivities have expired in 2015. Details of Alimta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-571) | Sep 26, 2011 |
| New Indication(I-601) | Jul 02, 2012 |
| Pediatric Exclusivity(PED) | Sep 17, 2014 |
| M(M-61) | Mar 17, 2014 |
| M(M-122) | Oct 17, 2015 |
Several oppositions have been filed on Alimta'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 Alimta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Alimta patents.
Alimta's Oppositions Filed in EPO
Alimta 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 Alimta 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 Alimta's family patents as well as insights into ongoing legal events on those patents.
Alimta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Alimta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 24, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Alimta Generic API suppliers:
Pemetrexed Disodium is the generic name for the brand Alimta. 18 different companies have already filed for the generic of Alimta, with Fresenius Kabi Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Alimta's generic
How can I launch a generic of Alimta before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Alimta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Alimta'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 Alimta -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg/vial | 01 Jul, 2008 | 1 | 24 Jan, 2017 | Extinguished | |
| 500 mg/vial | 04 Feb, 2008 | 2 | 24 Jan, 2017 | Extinguished | |
| 1000 mg/vial | 27 Jun, 2012 | 1 | 24 Nov, 2021 | Extinguished | |
| 750 mg/vial | 06 Oct, 2016 | 1 | 24 Nov, 2021 | Extinguished |
Alternative Brands for Alimta
Alimta which is used for treating certain types of cancer., has several other brand drugs using the same active ingredient (Pemetrexed Disodium). 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 | |
|---|---|---|
| Shilpa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Pemetrexed Disodium, Alimta's active ingredient. Check the complete list of approved generic manufacturers for Alimta
About Alimta
Alimta is a drug owned by Eli Lilly And Co. It is used for treating certain types of cancer. Alimta uses Pemetrexed Disodium as an active ingredient. Alimta was launched by Lilly in 2007.
Approval Date:
Alimta was approved by FDA for market use on 07 September, 2007.
Active Ingredient:
Alimta uses Pemetrexed Disodium as the active ingredient. Check out other Drugs and Companies using Pemetrexed Disodium ingredient
Treatment:
Alimta is used for treating certain types of cancer.
Dosage:
Alimta is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 500MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |
| EQ 100MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |