AMELUZ Drug Patent Profile
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Which patents cover Ameluz, and what generic alternatives are available?
Ameluz is a drug marketed by Biofrontera and is included in one NDA. There are two patents protecting this drug.
This drug has twenty-six patent family members in eighteen countries.
The generic ingredient in AMELUZ is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Ameluz
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 7, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for AMELUZ?
- What are the global sales for AMELUZ?
- What is Average Wholesale Price for AMELUZ?
Summary for AMELUZ
International Patents: | 26 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 13 |
Patent Applications: | 271 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AMELUZ |
What excipients (inactive ingredients) are in AMELUZ? | AMELUZ excipients list |
DailyMed Link: | AMELUZ at DailyMed |
![AMELUZ drug patent expirations Drug patent expirations by year for AMELUZ](/p/graph/s/t/AMELUZ-patent-expirations.png)
![Drug Prices for AMELUZ](/p/graph/drug-price/AMELUZ.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AMELUZ
Generic Entry Date for AMELUZ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GEL;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for AMELUZ
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Case Comprehensive Cancer Center | Phase 2 |
The Cleveland Clinic | Phase 2 |
Biofrontera, Inc. | Phase 2 |
Pharmacology for AMELUZ
Drug Class | Optical Imaging Agent Porphyrin Precursor |
Mechanism of Action | Fluorescence Contrast Activity |
US Patents and Regulatory Information for AMELUZ
AMELUZ is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AMELUZ is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting AMELUZ
Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL LESION-DIRECTED AND FIELD-DIRECTED TREATMENT OF ACTINIC KERATOSIS OF THE FACE AND SCALP WITH PHOTODYNAMIC THERAPY BY POSITIONING AN ILLUMINATION DEVICE IN AN APPROPRIATE DISTANCE AND ILLUMINATING THE TREATMENT AREA WITH NARROWBAND RED LIGHT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Biofrontera | AMELUZ | aminolevulinic acid hydrochloride | GEL;TOPICAL | 208081-001 | May 10, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Biofrontera | AMELUZ | aminolevulinic acid hydrochloride | GEL;TOPICAL | 208081-001 | May 10, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for AMELUZ
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Biofrontera | AMELUZ | aminolevulinic acid hydrochloride | GEL;TOPICAL | 208081-001 | May 10, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMELUZ
When does loss-of-exclusivity occur for AMELUZ?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 4659
Patent: NANOEMULSION
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 07338323
Patent: Nanoemulsion
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0720853
Patent: NANOEMULSÃO
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 70715
Patent: NANOEMULSION (NANOEMULSION)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 07003730
Patent: Nanoemulsion que comprende a) componente acuoso y b) un vehiculo con i) 0,1-15% de un componente lipofilico, ii) un tensoactivo y iii) un alcohol c3-c5; composicion que la comprende opcionalmente con un agente activo; proceso de preparacion de la nanoemulsion y de la composicion; kit; y uso para diagnosticar enfermedades dermicas y proliferativas, y tratar enfermedades virales, dermicas y proliferativas.
Estimated Expiration: ⤷ Sign Up
China
Patent: 1588792
Patent: Nanoemulsion
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 38801
Patent: Nanoémulsion (Nanoemulsion)
Estimated Expiration: ⤷ Sign Up
Patent: 20872
Patent: NANOÉMULSION (NANOEMULSION)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8934
Patent: ננו-תחליב (Nanoemulsion)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 58827
Estimated Expiration: ⤷ Sign Up
Patent: 10513363
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 09006088
Patent: NANOEMULSION. (NANOEMULSION.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 7061
Patent: NANOEMULSION
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 91917
Patent: НАНОЭМУЛЬСИЯ (NANOEMULSION)
Estimated Expiration: ⤷ Sign Up
Patent: 09128179
Patent: НАНОЭМУЛЬСИЯ
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0903468
Patent: NANOEMULSION
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 02107
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 1471
Patent: НАНОЕМУЛЬСІЇ[НАНОЭМУЛЬСИИ (NANOEMULSIONS)
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 833
Patent: NANOEMULSION
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering AMELUZ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 758098 | ⤷ Sign Up | |
Japan | 5558827 | ⤷ Sign Up | |
Ukraine | 101471 | НАНОЕМУЛЬСІЇ[НАНОЭМУЛЬСИИ (NANOEMULSIONS) | ⤷ Sign Up |
Japan | 2002529495 | ⤷ Sign Up | |
South Africa | 200104726 | Nano-emulsion of 5-aminolevulinic acid. | ⤷ Sign Up |
South Korea | 20230088755 | 광역학 요법용 조명 디바이스, 피부 질환 치료 방법 및 조명 디바이스 작동 방법 | ⤷ Sign Up |
Canada | 2351620 | EMULSION NANOMETRIQUE D'ACIDE 5-AMINOLEVULINIQUE (NANO-EMULSION OF 5-AMINOLEVULINIC ACID) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |