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LEVULAN Drug Profile

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Levulan is a drug marketed by Dusa and is included in one NDA. It is available from one supplier. There are five patents protecting this drug.

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

The generic ingredient in LEVULAN is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.

Summary for Tradename: LEVULAN

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Clinical Trials for: LEVULAN

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, 1999RXYes5,954,703<disabled> <disabled>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999RXYes8,216,289<disabled> <disabled>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999RXYes6,709,446<disabled> <disabled>
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Expired Patents for Tradename: LEVULAN

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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, 19995,079,262<disabled>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 19996,710,066<disabled>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 19995,422,093<disabled>
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Non-Orange Book Patents for Tradename: LEVULAN

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
6,223,071 Illuminator for photodynamic therapy and diagnosis which produces substantially uniform intensity visible light<disabled in preview>
8,030,836Illuminator for photodynamic therapy<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 Tradename: LEVULAN

Country Document Number Estimated Expiration
Spain2226188<disabled in preview>
Norway319662<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.

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