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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Johnson and Johnson
Harvard Business School
Cerilliant
Chinese Patent Office
QuintilesIMS
Colorcon
Medtronic
Daiichi Sankyo

Generated: August 19, 2018

DrugPatentWatch Database Preview

LEVULAN Drug Profile

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Which patents cover Levulan, and when can generic versions of Levulan launch?

Levulan is a drug marketed by Dusa and is included in one NDA. There are four patents protecting this drug.

This drug has thirty-one patent family members in twenty 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.

Drug patent expirations by year for LEVULAN
Generic Entry Opportunity Date for LEVULAN
Generic Entry Date for LEVULAN*:
Constraining patent/regulatory exclusivity:
TREATMENT OF MINIMALLY TO MODERATELY THICK ACTINIC KERATOSIS OF THE UPPER EXTREMITIES IN CONJUNCTION WITH A BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
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.

Medical Subject Heading (MeSH) Categories for LEVULAN
Synonyms for LEVULAN
.delta.-Aminolevulinic acid hydrochloride
0C1E43DB-1221-4963-BFA4-18D3170000A4
4-carboxy-2-oxobutan-1-aminium chloride
451A092
5 ALA HCL
5-amino levulinic acid hydrochloride
5-Amino-3-oxopentanoic acid (hydrochloride)
5-amino-4-keto-valeric acid
5-Amino-4-ketovaleric acid hydrochloride
5-AMINO-4-OXOPENTANOIC ACID HCL
5-Amino-4-oxopentanoic acid hydrochloride
5-amino-4-oxopentanoic acid hydrochloride;5-Amino-4-oxopentanoic acid
5-amino-4-oxopentanoic acid, chloride
5-Amino-4-oxovaleric acid hydrochloride
5-amino-levulinic acid hydrochloride
5-Aminolaevulinic acid hydrochloride
5-Aminolevulinate hydrochloride
5-Aminolevulinic acid (hydrochloride)
5-Aminolevulinic acid HCl
5-Aminolevulinic acid hydrochloride
5-aminolevulinic acid hydrochloride salt
5-Aminolevulinic acid hydrochloride, >=97.0% (AT)
5-Aminolevulinic acid hydrochloride, >=98%
5-Aminolevulinic acid hydrochloride, BioReagent, suitable for cell culture, powder, >=98%
5-Aminolevulinic acid hydrochloride, GMP
5-Aminolevulinic acid hydrochloride, particle size < 0.25 mm
5-Aminolevulinic Acid, Hydrochloride Salt
5-aminolevulinic acid.HCl
5451-09-2
A-6100
A-6102
A-6103
A0325
AB1005459
AC-4252
AC1L3WYV
AC1Q5HEA
ACT05562
AK-30504
AKOS015904495
ALA HCl
ALA-PDT
AlaCare
AM20100341
Ameluz
Ameluz (TN)
Aminolevulinic Acid HCl
Aminolevulinic acid hydrochloride
Aminolevulinic acid hydrochloride (JAN/USAN)
Aminolevulinic acid hydrochloride [USAN]
Aminolevulinic acid hydrochloride, United States Pharmacopeia (USP) Reference Standard
ANW-43114
AT-6127
AX8102341
BC210778
BCP9000174
BR-30504
C-04944
C5H9NO3.HCl
CA-291
CAS-5451-09-2
CC-21174
CCG-39079
CHEBI:132969
CHEMBL1200582
CS-2575
CTK1G9933
D02908
D0O4GY
DB-005367
delta-Aminolevulinic acid hydrochloride
DSSTox_CID_25914
DSSTox_GSID_45914
DSSTox_RID_81222
DTXSID5045914
EINECS 226-679-5
FT-0082845
Gleolan
Gliolan
GM8475
GS-3020
HMS1922F13
HY-N0305
I14-1649
KB-196689
KB-244625
KS-000001DZ
KSC269S3H
Levulan (TN)
Levulan Kerastick
Levulinic acid, 5-amino-, hydrochloride
Levulinic acid, 5-amino-, hydrochloride (8CI)
LS-87948
M-2865
MCULE-8125179397
MFCD00012869
MolPort-001-757-321
NCGC00095111-01
NCGC00095111-02
NCGC00095111-03
NCGC00178086-03
NSC 18509
NSC-18509
NSC-758687
NSC18509
NSC758687
OR002139
OR1490
PD-P-506-A
Pentanoic acid, 5-amino-4-oxo-, hydrochloride
Pentanoic acid, hydrochloride
Pentanoicacid, 5-amino-4-oxo-, hydrochloride (1:1)
Pharmakon1600-01504184
RL04038
RP23037
RTR-019277
S2553
SBB003880
SC-18502
SC-52394
SCHEMBL192308
SPECTRUM1504184
ST2411714
ST50824911
Tox21_111426
Tox21_111426_1
TPC-I025
TR-019277
UNII-V35KBM8JGR
V35KBM8JGR
ZLHFONARZHCSET-UHFFFAOYSA-N
ZX-AT009947

US Patents and Regulatory Information for LEVULAN

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 Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 Free Trial ➤ Try a Free Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for LEVULAN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,223,071 Illuminator for photodynamic therapy and diagnosis which produces substantially uniform intensity visible light ➤ Try a Free Trial
8,030,836 Illuminator for photodynamic therapy ➤ Try a Free Trial
7,190,109 Illuminator for photodynamic therapy ➤ Try a Free Trial
9,723,991 Illuminator for photodynamic therapy ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Queensland Health
Moodys
McKesson
Cipla
US Department of Justice
Express Scripts
Federal Trade Commission
Mallinckrodt

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.