Fusilev is a drug owned by Acrotech Biopharma Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 07, 2022. Details of Fusilev'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). | |||
| US6500829 | Substantially pure diastereoisomers of tetrahydrofolate derivatives |
Mar, 2022
(2 years ago) |
Expired
|
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 Fusilev and ongoing litigations to help you estimate the early arrival of Fusilev generic.
Fusilev's Litigations
Fusilev been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Mar 09, 1998, against patent number US6500829. The petitioner , challenged the validity of this patent, with WOOD et al as the respondent. Click below to track the latest information on how companies are challenging Fusilev's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6500829 | March, 1998 |
Decision
(28 Sep, 2001) | WOOD et al | |
FDA has granted some exclusivities to Fusilev. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Fusilev, 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 Fusilev.
Exclusivity Information
Fusilev holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Fusilev's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-637) | Apr 29, 2014 |
| Orphan Drug Exclusivity(ODE) | Apr 29, 2018 |
| Orphan Drug Exclusivity(ODE-10) | Apr 29, 2018 |
US patents provide insights into the exclusivity only within the United States, but Fusilev 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 Fusilev's family patents as well as insights into ongoing legal events on those patents.
Fusilev's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fusilev's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 07, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fusilev Generic API suppliers:
Levoleucovorin Calcium is the generic name for the brand Fusilev. 10 different companies have already filed for the generic of Fusilev, with Meitheal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fusilev's generic
How can I launch a generic of Fusilev before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fusilev's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fusilev'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 Fusilev -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/mL, 17.5 mL vial and 25 mL vial | 26 Oct, 2011 | 1 | 09 Mar, 2015 | 31 Dec, 2019 | Eligible |
| 50 mg/vial | 19 Dec, 2013 | 1 |
About Fusilev
Fusilev is a drug owned by Acrotech Biopharma Inc. Fusilev uses Levoleucovorin Calcium as an active ingredient. Fusilev was launched by Acrotech Biopharma in 2008.
Approval Date:
Fusilev was approved by FDA for market use on 07 March, 2008.
Active Ingredient:
Fusilev uses Levoleucovorin Calcium as the active ingredient. Check out other Drugs and Companies using Levoleucovorin Calcium ingredient
Dosage:
Fusilev is available in the following dosage forms - powder form for intravenous use, solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INTRAVENOUS |
| EQ 50MG BASE/VIAL | POWDER | Discontinued | INTRAVENOUS |
| EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INTRAVENOUS |