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 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
Summary for LEVULAN
| International Patents: | 10 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 151 |
| Clinical Trials: | 28 |
| Patent Applications: | 2,542 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Case Comprehensive Cancer Center | Phase 2 |
| Brigham and Women's Hospital | N/A |
| Mayo Clinic | Early Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for LEVULAN
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY
Methods for photodynamic therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY
Methods for photodynamic therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Dusa | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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
Estimated Expiration: ⤷ Try a Trial
Patent: 20103365
Estimated Expiration: ⤷ Try a Trial
Patent: 20267186
Estimated Expiration: ⤷ Try a Trial
Patent: 21102111
Estimated Expiration: ⤷ Try a Trial
Patent: 21107564
Estimated Expiration: ⤷ Try a Trial
Patent: 22209242
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 29792
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 11268
Estimated Expiration: ⤷ Try a Trial
Patent: 19123708
Estimated Expiration: ⤷ Try a Trial
Patent: 23130447
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Australia | 2020267186 | Methods for photodynamic therapy | ⤷ Try a Trial |
| Norway | 328315 | ⤷ Try a Trial | |
| European Patent Office | 1027093 | APPAREIL POUR APPLIQUER DE L'ACIDE PENTA-AMINOLEVULIQUE (APPARATUS FOR APPLYING 5-AMINOLEVULINIC ACID) | ⤷ Try a Trial |
| Australia | 753997 | ⤷ Try a Trial | |
| Turkey | 200001185 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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.
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