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Details for Generic Name: aminolevulinic acid hydrochloride

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Aminolevulinic acid hydrochloride is the generic ingredient in one branded drug marketed by Dusa and is included in one NDA. 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:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers: see list1
Formulation / Manufacturing:see details

Clinical Trials for: aminolevulinic acid hydrochloride

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

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Status: Withdrawn Condition: Brain Neoplasms

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

Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia
Status: Terminated Condition: Oral Leukoplakia

Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
Status: Not yet recruiting Condition: Primary Malignant Neoplasm of Nervous System; Glioma; Glioblastoma; Metastasis

Fluorescence-guided Surgery for Low- and High-grade Gliomas
Status: Recruiting Condition: Glioma

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

Gliadel Wafer and Fluorescence-Guided Surgery With 5-ALA Followed by Radiation Therapy And Temozolomide in Treating Patients With Primary Glioblastoma
Status: Active, not recruiting Condition: Glioblastoma

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

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, 1999RXYes6,709,446<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, 1999RXYes7,723,910<disabled><disabled>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999RXYes8,758,418<disabled><disabled>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999RXYes5,954,703<disabled><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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International Patent Family for Ingredient: aminolevulinic acid hydrochloride

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)9956827Nov 11, 1999
China1308553Aug 15, 2001
New Zealand507891Jul 25, 2003
Israel139397Nov 25, 2001
World Intellectual Property Organization (WIPO)9922802May 14, 1999
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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.

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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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