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LEVULAN Drug Patent Profile

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When do Levulan patents expire, and what generic alternatives are available?

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

This drug has eleven patent family members in three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Levulan

Levulan was eligible for patent challenges on December 3, 2003.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 12, 2038. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for LEVULAN

International Patents:	11
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	29
Patent Applications:	271
Drug Prices:	Drug price information for LEVULAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVULAN
DailyMed Link:	LEVULAN at DailyMed

Drug patent expirations by year for LEVULAN

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LEVULAN

Generic Entry Date for LEVULAN^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 020965 Dosage: SOLUTION;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LEVULAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institutes of Health (NIH)	Phase 2
National Cancer Institute (NCI)	Phase 2
Case Comprehensive Cancer Center	Phase 2

See all LEVULAN clinical trials

US Patents and Regulatory Information for LEVULAN

LEVULAN is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LEVULAN is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting LEVULAN

Methods for photodynamic therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for LEVULAN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	⤷ Sign Up	⤷ Sign Up
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	⤷ Sign Up	⤷ Sign Up
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	⤷ Sign Up	⤷ Sign Up
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	⤷ Sign Up	⤷ Sign Up
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for LEVULAN

When does loss-of-exclusivity occur for LEVULAN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 19200152
Patent: Methods for photodynamic therapy
Estimated Expiration: ⤷ Sign Up

Patent: 20103365
Patent: Methods for photodynamic therapy
Estimated Expiration: ⤷ Sign Up

Patent: 20267186
Patent: Methods for photodynamic therapy
Estimated Expiration: ⤷ Sign Up

Patent: 21102111
Patent: Methods for photodynamic therapy
Estimated Expiration: ⤷ Sign Up

Patent: 21107564
Patent: Methods for photodynamic therapy
Estimated Expiration: ⤷ Sign Up

Patent: 22209242
Patent: METHODS FOR PHOTODYNAMIC THERAPY
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 29792
Patent: METHODES DE THERAPIE PHOTODYNAMIQUE (METHODS FOR PHOTODYNAMIC THERAPY)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 11268
Estimated Expiration: ⤷ Sign Up

Patent: 19123708
Patent: 光線力学療法のための局所用組成物、閉塞性ドレッシング材、それを用いたキット、光線力学療法材料、および光線力学療法のための方法 (TOPICAL COMPOSITION FOR PHOTODYNAMIC THERAPY, OCCLUSIVE DRESSING MATERIAL, KIT USING THE SAME, PHOTODYNAMIC THERAPY MATERIAL, AND METHOD FOR PHOTODYNAMIC THERAPY)
Estimated Expiration: ⤷ Sign Up

Patent: 23130447
Patent: 光線力学的治療のための局所用組成物、閉塞性ドレッシング材、それを用いたキット、光線力学的治療用材料、および光線力学的治療のための方法 (TOPICAL COMPOSITION FOR PHOTODYNAMIC THERAPY, OBSTRUCTIVE DRESSING MATERIAL, KIT USING THE SAME, MATERIAL FOR PHOTODYNAMIC THERAPY, AND METHOD FOR PHOTODYNAMIC THERAPY)
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LEVULAN around the world.

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Country	Patent Number	Title	Estimated Expiration
Canada	2223522	UTILISATION D'ACIDE 5-AMINOLEVULIQUE POUR TRAITER OU DETECTER DES CELLULES A CROISSANCE RAPIDE D'ORIGINE EXOGENE (USE OF 5-AMINOLEVULINIC ACID FOR TREATING OR DETECTING RAPIDLY GROWING CELLS OF EXOGENOUS ORIGIN)	⤷ Sign Up
Germany	69634250		⤷ Sign Up
Australia	6034390		⤷ Sign Up
Norway	20002295		⤷ Sign Up
Argentina	015054	UN ILUMINADOR PARA DIAGNOSTICAR O TRATAR UNA SUPERFICIE CON RELIEVE	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration