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Aminolevulinic acid hydrochloride - Generic Drug Details

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What are the generic drug sources for aminolevulinic acid hydrochloride and what is the scope of aminolevulinic acid hydrochloride patent protection?

Aminolevulinic acid hydrochloride is the generic ingredient in three branded drugs marketed by Nxdc, Biofrontera, and Dusa, and is included in three NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aminolevulinic acid hydrochloride has forty-four patent family members in twenty-one countries.

There are six drug master file entries for aminolevulinic acid hydrochloride. Three suppliers are listed for this compound.

Summary for aminolevulinic acid hydrochloride

International Patents:	44
US Patents:	5
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	6
Suppliers / Packagers:	3
Bulk Api Vendors:	101
Clinical Trials:	67
Patent Applications:	219
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aminolevulinic acid hydrochloride
DailyMed Link:	aminolevulinic acid hydrochloride at DailyMed

Pharmacology for aminolevulinic acid hydrochloride

Ingredient-type	Porphyrinogens
Drug Class	Porphyrin Precursor

Medical Subject Heading (MeSH) Categories for aminolevulinic acid hydrochloride

Photosensitizing Agents

Synonyms for aminolevulinic acid hydrochloride

.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 (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

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 aminolevulinic acid hydrochloride

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
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016		RX	Yes	Yes
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016		RX	Yes	Yes			Y

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Expired US Patents for aminolevulinic acid hydrochloride

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

Non-Orange Book US Patents for aminolevulinic acid hydrochloride

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

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International Patents for aminolevulinic acid hydrochloride

Country	Document Number	Estimated Expiration
Portugal	1075315
Canada	2351620
Germany	69922944
Norway	20005342