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Aminolevulinic acid hydrochloride - Generic Drug Details
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This ingredient has forty-three patent family members in twenty-one countries.
There are six drug master file entries for aminolevulinic acid hydrochloride. Two suppliers are listed for this compound.
Summary for Generic Name: aminolevulinic acid hydrochloride
| Tradenames: | 2 |
| Patents: | 5 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: see list | 6 |
| Suppliers / Packaging: see list | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: aminolevulinic acid hydrochloride
| Ingredient-type | Porphyrinogens |
| Drug Class | Porphyrin Precursor |
Clinical Trials for: aminolevulinic acid hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | 6,709,446 | May 1, 2018 | ||||||||||||||||||||
Biofrontera | AMELUZ | aminolevulinic acid hydrochloride | GEL;TOPICAL | 208081-001 | May 10, 2016 | RX | Yes | May 10, 2019 | |||||||||||||||||||||
Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | 7,723,910 | Jun 17, 2019 | ||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: aminolevulinic acid hydrochloride
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | 5,079,262 | <disabled> | ||||||||||||||||||||||
Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | 5,422,093 | <disabled> | ||||||||||||||||||||||
Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | 5,211,938 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: aminolevulinic acid hydrochloride
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,030,836 | Illuminator for photodynamic therapy | <disabled in preview> | |||||||||||||||||||||||||||
| 6,223,071 | Illuminator for photodynamic therapy and diagnosis which produces substantially uniform intensity visible light | <disabled in preview> | |||||||||||||||||||||||||||
| 7,190,109 | Illuminator for photodynamic therapy | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Ingredient: aminolevulinic acid hydrochloride
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Denmark | 1566200 | <disabled in preview> | |||||||||||||||||||||||||||
| Hungary | 0101340 | <disabled in preview> | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 9922802 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
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