Details for New Drug Application (NDA): 020965
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NDA 020965 describes LEVULAN, which is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. It is available from one supplier. There are five 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.
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: | Sun Pharm Inds Inc |
| Ingredient: | aminolevulinic acid hydrochloride |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 | Sun Pharmaceutical Industries, 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 | Sun Pharmaceutical Industries, 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: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 20% | ||||
| Approval Date: | Dec 3, 1999 | TE: | RLD: | Yes | |||||
| Patent: | 10,357,567 | Patent Expiration: | Jan 12, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY | ||||||||
| Patent: | 11,077,192 | Patent Expiration: | Jan 12, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACTINIC KERATOSES OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY | ||||||||
| Patent: | 11,135,293 | Patent Expiration: | Jan 12, 2038 | Product 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 |
|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | 7,723,910 | ⤷ Subscribe |
| Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | 5,079,262 | ⤷ Subscribe |
| Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | 6,710,066 | ⤷ Subscribe |
| Sun Pharm Inds Inc | LEVULAN | aminolevulinic acid hydrochloride | SOLUTION;TOPICAL | 020965-001 | Dec 3, 1999 | 8,216,289 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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