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Profile for Tradename: LEVULAN

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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 list2

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>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999RXYes7,723,910<disabled><disabled>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999RXYes8,758,418<disabled><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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International Patent Family for Tradename: LEVULAN

Country Document Number Publication Date
European Patent Office1075315Dec 29, 2004
Australia3858699Nov 23, 1999
Brazil9911781Sep 25, 2001
World Intellectual Property Organization (WIPO)9956827Mar 09, 2000
Norway20002295Apr 28, 2000
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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 information. There is no warranty that the information contained herein is error free. 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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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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