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AMELUZ Drug 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.
The generic ingredient in AMELUZ is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.
Summary for AMELUZ
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 77 |
| Clinical Trials: | 12 |
| Patent Applications: | 4,725 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AMELUZ |
| DailyMed Link: | AMELUZ at DailyMed |
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 3 |
Pharmacology for AMELUZ
| Drug Class | Porphyrin Precursor |
US Patents and Regulatory Information for AMELUZ
| 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 | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMELUZ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 200104726 | Start Trial |
| European Patent Office | 1128812 | Start Trial |
| Germany | 59908665 | Start Trial |
| Japan | 2002529495 | Start Trial |
| Portugal | 1128812 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
