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Last Updated: June 23, 2024

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LEVULAN Drug Patent Profile


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When do Levulan patents expire, and when can generic versions of Levulan launch?

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

This drug has ten 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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Drug patent expirations by year for LEVULAN
Drug Prices for LEVULAN

See drug prices for LEVULAN

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LEVULAN
Generic Entry Date for LEVULAN*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
National Institutes of Health (NIH)Phase 2
National Cancer Institute (NCI)Phase 2
Case Comprehensive Cancer CenterPhase 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

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

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


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

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

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
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.

Country Patent Number Title Estimated Expiration
Hungary 0004737 ⤷  Sign Up
Australia 1278399 ⤷  Sign Up
Canada 3029792 METHODES DE THERAPIE PHOTODYNAMIQUE (METHODS FOR PHOTODYNAMIC THERAPY) ⤷  Sign Up
Australia 6034390 ⤷  Sign Up
Japan 4837826 ⤷  Sign Up
Norway 328315 ⤷  Sign Up
Norway 319662 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.