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Serving leading biopharmaceutical companies globally:

Novartis
Express Scripts
Cipla
Medtronic
Queensland Health
AstraZeneca
Colorcon
QuintilesIMS
Harvard Business School
US Department of Justice

Generated: November 21, 2017

DrugPatentWatch Database Preview

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 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. Two suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.

Summary for 020965

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:5
Formulation / Manufacturing:see details

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength20%
Approval Date:Dec 3, 1999TE:RLD:Yes
Patent:► SubscribePatent Expiration:Oct 31, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
Patent:► SubscribePatent Expiration:May 1, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
Patent:► SubscribePatent Expiration:Jun 17, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP

Expired Orange Book Patents for NDA: 020965

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999► Subscribe► Subscribe
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999► Subscribe► Subscribe
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999► Subscribe► Subscribe
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999► Subscribe► Subscribe
Dusa
LEVULAN
aminolevulinic acid hydrochloride
SOLUTION;TOPICAL020965-001Dec 3, 1999► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

McKesson
Fuji
Argus Health
Daiichi Sankyo
Citi
Boehringer Ingelheim
Moodys
Covington
Novartis
Chinese Patent Office

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 verifification 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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