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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

Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome
Status: Not yet recruiting Condition: Basal Cell Nevus Syndrome

The Use of 5-aminolevulinic Acid (ALA) as an Intraoperative Tumor Marker for Resection of Pediatric Central Nervous System (CNS) Tumors
Status: Not yet recruiting Condition: Central Nervous System Tumor, Pediatric

Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis
Status: Not yet recruiting Condition: Actinic Cheilitis

Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne
Status: Completed Condition: Acne Vulgaris

Use Of The Dietary Supplement 5-ALA And Its Relationship With Sleep And Mood
Status: Completed Condition: Insomnia; Nocturnal Awakening; Irritability; Coping Behavior; Stress

A Study of the Specificity and Sensitivity of 5-ALA Fluorescence in Malignant Brain Tumors
Status: Withdrawn Condition: Brain Neoplasms

Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)
Status: Completed Condition: Keratosis, Actinic

Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
Status: Completed Condition: Actinic Keratosis

Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses
Status: Active, not recruiting Condition: Actinic Keratosis

Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme
Status: Terminated Condition: Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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
New Zealand504366Dec 20, 2002
China1308553Aug 15, 2001
Germany69825464Sep 15, 2005
European Patent Office1510233Mar 02, 2005
Argentina015054Apr 11, 2001
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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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