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Aminolevulinic acid hydrochloride - Generic Drug Details
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What are the generic drug sources for aminolevulinic acid hydrochloride and what is the scope of patent protection?
Aminolevulinic acid hydrochloride
is the generic ingredient in three branded drugs marketed by Nxdc, Biofrontera, and Dusa, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Aminolevulinic acid hydrochloride has three patent family members in three countries.
There are six drug master file entries for aminolevulinic acid hydrochloride. Two suppliers are listed for this compound.
Summary for aminolevulinic acid hydrochloride
| International Patents: | 3 |
| US Patents: | 1 |
| Tradenames: | 3 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 6 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 119 |
| Clinical Trials: | 83 |
| Patent Applications: | 252 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for aminolevulinic acid hydrochloride |
| DailyMed Link: | aminolevulinic acid hydrochloride at DailyMed |
Recent Clinical Trials for aminolevulinic acid hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| photonamic GmbH & Co. KG | Phase 2 |
| LifePhotonic GmbH | Phase 2 |
| University Hospital Muenster | Phase 2 |
Pharmacology for aminolevulinic acid hydrochloride
| Drug Class | Porphyrin Precursor |
Medical Subject Heading (MeSH) Categories for aminolevulinic acid hydrochloride
US Patents and Regulatory Information for aminolevulinic acid hydrochloride
| 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 | ||||
| Nxdc | GLEOLAN | aminolevulinic acid hydrochloride | FOR SOLUTION;ORAL | 208630-001 | Jun 6, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | 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 aminolevulinic acid hydrochloride
| 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 |
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | Start Trial | Start Trial |
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | Start Trial | Start Trial |
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | Start Trial | Start Trial |
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | Start Trial | Start Trial |
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | Start Trial | Start Trial |
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aminolevulinic acid hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 3029792 | Start Trial |
| Australia | 2019200152 | Start Trial |
| Japan | 2019123708 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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