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Aminolevulinic acid hydrochloride - Generic Drug Details

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Aminolevulinic acid hydrochloride is the generic ingredient in two branded drugs marketed by Dusa and Biofrontera, and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-three patent family members in twenty-one countries.

There are six drug master file entries for aminolevulinic acid hydrochloride. One supplier is listed for this compound.

Summary for Generic Name: aminolevulinic acid hydrochloride

Tradenames:2
Patents:5
Applicants:2
NDAs:2
Drug Master File Entries: see list6
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

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;TOPICAL020965-001Dec 3, 1999RXYes6,709,446<disabled> <disabled>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999RXYes8,216,289<disabled> <disabled>
Biofrontera
AMELUZ
aminolevulinic acid hydrochloride
GEL;TOPICAL208081-001May 10, 2016RXYes<disabled><disabled>
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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;TOPICAL020965-001Dec 3, 19995,422,093<disabled>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 19995,079,262<disabled>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 19996,710,066<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
8,030,836Illuminator 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>
7,190,109Illuminator 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
Norway20005342<disabled in preview>
Spain2237102<disabled in preview>
Australia1278399<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.

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