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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 / Packaging: see list2
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, 1999RXYes8,758,418<disabled><disabled>
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, 1999RXYes7,723,910<disabled><disabled>
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999RXYes6,709,446<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
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 Ingredient: aminolevulinic acid hydrochloride

Country Document Number Publication Date
Japan2002513660May 14, 2002
Israel135850May 20, 2001
Hungary0004737May 28, 2001
Czech Republic20004038Jun 13, 2001
Germany69825464Sep 15, 2005
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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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Copyright 2002-2015 thinkBiotech LLC
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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