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Last Updated: October 6, 2022

Details for New Drug Application (NDA): 020965


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NDA 020965 describes LEVULAN, which is a drug marketed by Dusa and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the LEVULAN profile page.

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.
Summary for 020965
Tradename:LEVULAN
Applicant:Dusa
Ingredient:aminolevulinic acid hydrochloride
Patents:3
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 020965
Generic Entry Date for 020965*:
Constraining patent/regulatory exclusivity:
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.

Medical Subject Heading (MeSH) Categories for 020965
Suppliers and Packaging for NDA: 020965
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965 NDA DUSA Pharmaceuticals, Inc. 67308-101 67308-101-01 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE
LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965 NDA DUSA Pharmaceuticals, Inc. 67308-101 67308-101-02 2 APPLICATOR in 1 CARTON (67308-101-02) > 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength20%
Approval Date:Dec 3, 1999TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Jan 12, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY
Patent:See Plans and PricingPatent Expiration:Jan 12, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY
Patent:See Plans and PricingPatent Expiration:Jan 12, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY

Expired US Patents for NDA 020965

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

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