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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for LEVULAN?
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- What is Average Wholesale Price for LEVULAN?
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 |
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
Sponsor | Phase |
---|---|
National Institutes of Health (NIH) | Phase 2 |
National Cancer Institute (NCI) | Phase 2 |
Case Comprehensive Cancer Center | Phase 2 |
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 |
>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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 9101727 | ⤷ Sign Up | |
Austria | 285817 | ⤷ Sign Up | |
New Zealand | 504366 | Method and apparatus for applying 5-aminolevulinic acid (5-amino-4-oxo-pentanoic acid) | ⤷ Sign Up |
Austria | 287709 | ⤷ Sign Up | |
Poland | 344106 | ⤷ Sign Up | |
Australia | 2024205278 | METHODS FOR PHOTODYNAMIC THERAPY | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |