Levulan is a drug owned by Dusa Pharmaceuticals Inc. It is protected by 11 US drug patents filed from 2013 to 2023. Out of these, 5 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 12, 2038. Details of Levulan'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5079262 | Method of detection and treatment of malignant and non-malignant lesions utilizing 5-aminolevulinic acid |
Sep, 2013
(10 years ago) |
Expired
|
| US5954703 | Method and apparatus for applying 5-aminolevulinic acid |
Oct, 2017
(6 years ago) |
Expired
|
| US8758418 | Illuminator for photodynamic therapy |
May, 2018
(6 years ago) |
Expired
|
| US8216289 | Illuminator for photodynamic therapy |
May, 2018
(6 years ago) |
Expired
|
| US6709446 | Illuminator for photodynamic therapy and diagnosis which produces substantially uniform intensity visible light |
May, 2018
(6 years ago) |
Expired
|
| US7723910 | Method of photodynamically diagnosing or treating a contoured surface |
Jun, 2019
(5 years ago) |
Expired
|
| US10357567 | Methods for photodynamic therapy |
Jan, 2038
(13 years from now) | Active |
| US11571478 | Methods for photodynamic therapy |
Jan, 2038
(13 years from now) | Active |
| US11135293 | Methods for photodynamic therapy |
Jan, 2038
(13 years from now) | Active |
| US11690914 | Methods for photodynamic therapy |
Jan, 2038
(13 years from now) | Active |
| US11077192 | Methods for photodynamic therapy |
Jan, 2038
(13 years 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 Levulan's patents.
Latest Legal Activities on Levulan's Patents
Given below is the list of recent legal activities going on the following patents of Levulan.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Email Notification | 06 Jul, 2023 | US11690914 |
| Patent eGrant Notification | 04 Jul, 2023 | US11690914 |
| Email Notification | 04 Jul, 2023 | US11690914 |
| Patent Issue Date Used in PTA Calculation | 04 Jul, 2023 | US11690914 |
| Electronic Review | 04 Jul, 2023 | US11690914 |
| Recordation of Patent eGrant | 04 Jul, 2023 | US11690914 |
| Recordation of Patent Grant Mailed | 04 Jul, 2023 | US11690914 |
| Mail Patent eGrant Notification | 04 Jul, 2023 | US11690914 |
| Email Notification | 15 Jun, 2023 | US11690914 |
| Electronic Review | 15 Jun, 2023 | US11690914 |
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 Levulan and ongoing litigations to help you estimate the early arrival of Levulan generic.
Levulan's Litigations
Levulan has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 19, 2021, against patent number US10357567. The petitioner Biofrontera Inc. et al., challenged the validity or infringement of this patent, with DUSA Pharmaceuticals, Inc. et al. as the respondent. Click below to track the latest information on how companies are challenging Levulan's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10357567 | October, 2021 | Terminated-Dismissed | DUSA Pharmaceuticals, Inc. et al. | Biofrontera Inc. et al. |
FDA has granted some exclusivities to Levulan. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Levulan, 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 Levulan.
Exclusivity Information
Levulan holds 2 exclusivities. All of its exclusivities have expired in 2021. Details of Levulan's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-82) | Mar 12, 2013 |
| New Indication(I-766) | Mar 09, 2021 |
US patents provide insights into the exclusivity only within the United States, but Levulan 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 Levulan's family patents as well as insights into ongoing legal events on those patents.
Levulan's family patents
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Generic Launch
Generic Release Date:
Levulan's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 12, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Levulan Generics:
There are no approved generic versions for Levulan as of now.
About Levulan
Levulan is a drug owned by Dusa Pharmaceuticals Inc. It is used for treating actinic keratoses on the upper extremities, face, and scalp through photodynamic therapy. Levulan uses Aminolevulinic Acid Hydrochloride as an active ingredient. Levulan was launched by Dusa in 1999.
Market Authorisation Date:
Levulan was approved by FDA for market use on 03 December, 1999.
Active Ingredient:
Levulan uses Aminolevulinic Acid Hydrochloride as the active ingredient. Check out other Drugs and Companies using Aminolevulinic Acid Hydrochloride ingredient
Treatment:
Levulan is used for treating actinic keratoses on the upper extremities, face, and scalp through photodynamic therapy.
Dosage:
Levulan is available in solution form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20% | SOLUTION | Prescription | TOPICAL |