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 Sun Pharm Inds Inc and is included in one NDA. There are ten patents protecting this drug.
This drug has twenty-four patent family members in seven countries.
The generic ingredient in LEVULAN is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Four 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 October 13, 2036. 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 Deep Research
Questions you can ask:
- What is the 5 year forecast for LEVULAN?
- What are the global sales for LEVULAN?
- What is Average Wholesale Price for LEVULAN?
Summary for LEVULAN
International Patents: | 24 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 29 |
Patent Applications: | 486 |
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 ten US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LEVULAN is ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>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 |
---|---|---|---|---|---|---|---|
Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | ⤷ Try for Free | ⤷ Try for Free |
Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | ⤷ Try for Free | ⤷ Try for Free |
Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | ⤷ Try for Free | ⤷ Try for Free |
Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | ⤷ Try for Free | ⤷ Try for Free |
>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: 18250595
Patent: Adjustable illuminators and methods for photodynamic therapy and diagnosis
Estimated Expiration: ⤷ Try for Free
Patent: 23285927
Patent: ADJUSTABLE ILLUMINATORS AND METHODS FOR PHOTODYNAMIC THERAPY AND DIAGNOSIS
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 57840
Patent: ILLUMINATEURS REGLABLES ET PROCEDES DE THERAPIE PHOTODYNAMIQUE ET DIAGNOSTIC (ADJUSTABLE ILLUMINATORS AND METHODS FOR PHOTODYNAMIC THERAPY AND DIAGNOSIS)
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 62145
Patent: DISPOSITIF D'ÉCLAIRAGE RÉGLABLE POUR DIAGNOSTIC ET THÉRAPIE PHOTODYNAMIQUE (ADJUSTABLE ILLUMINATOR FOR PHOTODYNAMIC THERAPY AND DIAGNOSIS)
Estimated Expiration: ⤷ Try for Free
Patent: 51161
Patent: DISPOSITIF D'ÉCLAIRAGE RÉGLABLE POUR DIAGNOSTIC ET THÉRAPIE PHOTODYNAMIQUE (ADJUSTABLE ILLUMINATOR FOR PHOTODYNAMIC THERAPY AND DIAGNOSIS)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 82832
Estimated Expiration: ⤷ Try for Free
Patent: 96967
Estimated Expiration: ⤷ Try for Free
Patent: 20516393
Patent: 光線力学療法及び診断のための調節可能な照射装置及び方法
Estimated Expiration: ⤷ Try for Free
Patent: 23162440
Patent: 光線力学療法及び診断のための調節可能な照射装置及び方法 (ADJUSTABLE ILLUMINATORS AND METHODS FOR PHOTODYNAMIC THERAPY AND DIAGNOSIS)
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 62145
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 60807
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
European Patent Office | 3362145 | DISPOSITIF D'ÉCLAIRAGE RÉGLABLE POUR DIAGNOSTIC ET THÉRAPIE PHOTODYNAMIQUE (ADJUSTABLE ILLUMINATOR FOR PHOTODYNAMIC THERAPY AND DIAGNOSIS) | ⤷ Try for Free |
Austria | 272422 | ⤷ Try for Free | |
Australia | 2020103365 | Methods for photodynamic therapy | ⤷ Try for Free |
Slovenia | 1027093 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LEVULAN
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