Ameluz is a drug owned by Biofrontera Bioscience Gmbh. It is protected by 3 US drug patents filed from 2016 to 2023. Out of these, 2 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 15, 2040. Details of Ameluz'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). | |||
| US6559183 | Nano-emulsion of 5-aminolevulinic acid |
Nov, 2019
(4 years ago) |
Expired
|
| US11540981 | Nanoemulsion formulation with improved stability and cell penetration |
Feb, 2028
(3 years from now) | Active |
| US11235169 | Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device |
Oct, 2040
(16 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 Ameluz's patents.
Latest Legal Activities on Ameluz's Patents
Given below is the list of recent legal activities going on the following patents of Ameluz.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Email Notification | 21 Mar, 2024 | US11540981 |
| Mail O.P. Petition Decision | 21 Mar, 2024 | US11540981 |
| Mail-Petition Decision - Denied | 19 Mar, 2024 | US11540981 |
| Petition Decision - Denied | 18 Mar, 2024 | US11540981 |
| O.P. Petition Decision | 18 Mar, 2024 | US11540981 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 06 Dec, 2023 | US11540981 |
| Petition Entered | 27 Apr, 2023 | US11540981 |
| Recordation of Patent Grant Mailed | 03 Jan, 2023 | US11540981 |
| Patent Issue Date Used in PTA Calculation | 03 Jan, 2023 | US11540981 |
| Email Notification | 15 Dec, 2022 | US11540981 |
FDA has granted several exclusivities to Ameluz. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ameluz, 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 Ameluz.
Exclusivity Information
Ameluz holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Ameluz's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 10, 2019 |
US patents provide insights into the exclusivity only within the United States, but Ameluz 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 Ameluz's family patents as well as insights into ongoing legal events on those patents.
Ameluz's family patents
Coming Soon
Patent Strength Analyzer
YesNo
Thank you for your response 🥳
Generic Launch
Generic Release Date:
Ameluz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 15, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ameluz Generics:
There are no approved generic versions for Ameluz as of now.
About Ameluz
Ameluz is a drug owned by Biofrontera Bioscience Gmbh. It is used for treating actinic keratosis on the face and scalp through photodynamic therapy. Ameluz uses Aminolevulinic Acid Hydrochloride as an active ingredient. Ameluz was launched by Biofrontera in 2016.
Market Authorisation Date:
Ameluz was approved by FDA for market use on 10 May, 2016.
Active Ingredient:
Ameluz uses Aminolevulinic Acid Hydrochloride as the active ingredient. Check out other Drugs and Companies using Aminolevulinic Acid Hydrochloride ingredient
Treatment:
Ameluz is used for treating actinic keratosis on the face and scalp through photodynamic therapy.
Dosage:
Ameluz is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10% | GEL | Prescription | TOPICAL |