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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.

Summary for LEVULAN

International Patents:	31
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	101
Clinical Trials:	25
Patent Applications:	151
Formulation / Manufacturing:	see details
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

Generic Entry Opportunity 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:

020965

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

Photosensitizing Agents

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
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes

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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
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999

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
8,030,836	Illuminator for photodynamic therapy
7,190,109	Illuminator for photodynamic therapy
9,723,991	Illuminator for photodynamic therapy

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International Patents for LEVULAN

Country	Document Number	Estimated Expiration
Czech Republic	20004038
Germany	69922944
European Patent Office	1566200
Spain	2237102
Canada	2331090