AMELUZ Drug Patent Profile
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Which patents cover Ameluz, and when can generic versions of Ameluz launch?
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
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: | 12 |
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 |
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 |
---|---|
Dartmouth-Hitchcock Medical Center | Early Phase 1 |
Jeffrey B. Travers, MD, PhD | Early Phase 1 |
Royal Cornwall Hospitals Trust | Phase 4 |
Pharmacology for AMELUZ
Drug Class | Optical Imaging Agent Porphyrin Precursor |
Mechanism of Action | Fluorescence Contrast Activity |
Anatomical Therapeutic Chemical (ATC) Classes for AMELUZ
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Biofrontera | AMELUZ | aminolevulinic acid hydrochloride | GEL;TOPICAL | 208081-001 | May 10, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
>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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 07338323
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0720853
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 70715
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 07003730
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1588792
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 38801
Estimated Expiration: ⤷ Try a Trial
Patent: 20872
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8934
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 58827
Estimated Expiration: ⤷ Try a Trial
Patent: 10513363
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 09006088
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 7061
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 91917
Estimated Expiration: ⤷ Try a Trial
Patent: 09128179
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0903468
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 02107
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 1471
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 833
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Argentina | 064659 | NANOEMULSION | ⤷ Try a Trial |
Australia | 758098 | ⤷ Try a Trial | |
Portugal | 1128812 | ⤷ Try a Trial | |
China | 101588792 | Nanoemulsion | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |