Aminolevulinic acid hydrochloride - Generic Drug Details

What are the generic sources for aminolevulinic acid hydrochloride and what is the scope of freedom to operate?

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

Aminolevulinic acid hydrochloride has thirty-seven patent family members in eighteen countries.

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

Summary for aminolevulinic acid hydrochloride

International Patents:	37
US Patents:	7
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	100
Patent Applications:	6,457
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aminolevulinic acid hydrochloride
What excipients (inactive ingredients) are in aminolevulinic acid hydrochloride?	aminolevulinic acid hydrochloride excipients list
DailyMed Link:	aminolevulinic acid hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for aminolevulinic acid hydrochloride

Constraining patent/regulatory exclusivity:

11,690,914

Dosage:

SOLUTION;TOPICAL

Constraining patent/regulatory exclusivity:

11,540,981

Dosage:

GEL;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.

Recent Clinical Trials for aminolevulinic acid hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lee's Pharmaceutical Limited	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1/Phase 2
University of Zurich	Early Phase 1

See all aminolevulinic acid hydrochloride clinical trials

Pharmacology for aminolevulinic acid hydrochloride

Drug Class	Optical Imaging Agent Porphyrin Precursor
Mechanism of Action	Fluorescence Contrast Activity

Medical Subject Heading (MeSH) Categories for aminolevulinic acid hydrochloride

Photosensitizing Agents

Anatomical Therapeutic Chemical (ATC) Classes for aminolevulinic acid hydrochloride

L01XD	Sensitizers used in photodynamic/radiation therapy
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	10,357,567
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016		RX	Yes	Yes	11,235,169
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016		RX	Yes	Yes	11,540,981		Y
Nxdc	GLEOLAN	aminolevulinic acid hydrochloride	FOR SOLUTION;ORAL	208630-001	Jun 6, 2017		RX	Yes	Yes
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	11,077,192
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	11,571,478
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	11,135,293

Expired US Patents for aminolevulinic acid hydrochloride

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	6,709,446
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016	6,559,183
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	8,758,418
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	8,216,289
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	5,954,703
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	6,710,066
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	5,422,093

International Patents for aminolevulinic acid hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2021102111	Methods for photodynamic therapy
Canada	3029792	METHODES DE THERAPIE PHOTODYNAMIQUE (METHODS FOR PHOTODYNAMIC THERAPY)
Japan	2019123708	光線力学療法のための局所用組成物、閉塞性ドレッシング材、それを用いたキット、光線力学療法材料、および光線力学療法のための方法 (TOPICAL COMPOSITION FOR PHOTODYNAMIC THERAPY, OCCLUSIVE DRESSING MATERIAL, KIT USING THE SAME, PHOTODYNAMIC THERAPY MATERIAL, AND METHOD FOR PHOTODYNAMIC THERAPY)
Chile	2007003730	Nanoemulsion que comprende a) componente acuoso y b) un vehiculo con i) 0,1-15% de un componente lipofilico, ii) un tensoactivo y iii) un alcohol c3-c5; composicion que la comprende opcionalmente con un agente activo; proceso de preparacion de la nanoemulsion y de la composicion; kit; y uso para diagnosticar enfermedades dermicas y proliferativas, y tratar enfermedades virales, dermicas y proliferativas.
Australia	2020103365	Methods for photodynamic therapy
Australia	2007338323	Nanoemulsion
South Africa	200903468	NANOEMULSION

Aminolevulinic acid hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for 5-Aminolevulinic Acid Hydrochloride (ALA)

Market Overview

The global 5-Aminolevulinic Acid Hydrochloride (ALA) market is poised for significant growth, driven by various factors including increasing healthcare infrastructure, rising incidence of chronic diseases, and advancements in medical technology.

Market Size and Forecast

As of 2022, the global 5-Aminolevulinic Acid Hydrochloride (ALA) market was valued at USD 89.04 million. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 7.29% from 2022 to 2030, reaching a market size of USD 159.58 million by 2030[1][2].

Regional Analysis

North America

North America emerged as the largest market for 5-Aminolevulinic Acid Hydrochloride (ALA) in 2022, holding a market share of 36.66%. This dominance is attributed to the region's advanced healthcare infrastructure and substantial investments in research and development (R&D). The surge in cancer incidences and the need for effective diagnostic and therapeutic tools also contribute to the market's growth in this region[1][2].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing market during the forecast period, driven by increasing per capita expenditure and a rising incidence of cancer in emerging economies such as China and India. These countries, being the most populous in the world, present a significant market opportunity for ALA[1][2].

Purity Segment Analysis

The purity segment of the ALA market is divided into purity 98%, purity 95%, and others. In 2022, the purity 98% segment dominated the market with a share of around 64.71% and market revenue of USD 57.62 million. This high demand is primarily driven by the R&D sector and the increasing prevalence of chronic diseases like cancer[1][2].

Application Segment Analysis

Pharmaceutical Sector

The pharmaceutical segment dominated the market in 2022 with a share of 44.02% and market revenue of USD 39.20 million. ALA is widely used in cancer diagnosis, particularly in photodynamic therapy (PDT) for visualizing and treating various types of cancer, such as bladder cancer and skin cancer[1][2].

Agricultural Use

ALA is also used as a growth regulator in plants, contributing to its demand in the agricultural sector. However, this segment is smaller compared to the pharmaceutical sector[2].

Distribution Channel Analysis

The distribution channel segment is divided into online sales and offline sales. In 2022, the offline sales segment dominated the market with a share of 69.34% and market revenue of USD 61.74 million. The preference for offline sales is attributed to the nature of the product and the trust associated with traditional purchasing methods[1][2].

Market Growth Drivers

Increasing Incidence of Chronic Diseases

The rising incidence of chronic diseases, particularly cancer, is a significant driver for the ALA market. ALA's role in photodynamic therapy and its ability to penetrate tumor cell membranes make it a valuable tool in cancer diagnosis and treatment[1][2].

Advancements in Healthcare Infrastructure

Better healthcare infrastructure, especially in North America, and increased investments in R&D are driving the market growth. Emerging economies in the Asia-Pacific region are also contributing to this growth due to their increasing per capita expenditure on healthcare[1][2].

Market Challenges

Economic Slowdown

The economic slowdown has led to a decrease in GDP growth, resulting in a disparity between production and earnings. This economic downturn can reduce investments in R&D, posing a challenge to the market growth of ALA[1].

High R&D Costs

High costs associated with research and development, particularly in the pharmaceutical sector, can act as a restraint for the market. These costs are reflected in the high prices of drugs, which can limit market expansion[2].

Competitive Strategy

Key players in the ALA market are adopting strategies such as product innovations, mergers and acquisitions, joint ventures, and collaborations to enhance their market position. For example, Photonamic Gmbh & Co. KG's acquisition of the Oncology business of MolecuLight Inc. expanded their R&D activities and market reach[2].

Regulatory and Clinical Landscape

ALA has been approved for various indications, including the treatment of superficial basal cell carcinoma and malignant glioma of the brain. It holds orphan drug status in the US, Japan, and South Korea, and has fast-track designation in the US. Clinical trials are ongoing for other indications such as ovarian epithelial carcinoma and breast cancer[3].

Financial Trajectory

The financial trajectory of the ALA market is positive, with a projected growth from USD 89.04 million in 2022 to USD 159.58 million by 2030. This growth is supported by increasing demand in the pharmaceutical sector, advancements in healthcare infrastructure, and expanding applications in agriculture and other fields[1][2].

Key Takeaways

• The global ALA market is expected to grow at a CAGR of 7.29% from 2022 to 2030.
• North America is the largest market, while the Asia-Pacific region is expected to grow the fastest.
• The purity 98% segment and pharmaceutical application segment dominate the market.
• Offline sales are preferred over online sales.
• Increasing incidence of chronic diseases and advancements in healthcare infrastructure are key drivers.
• Economic slowdown and high R&D costs are significant challenges.

FAQs

What is the current market size of the 5-Aminolevulinic Acid Hydrochloride (ALA) market?

The global 5-Aminolevulinic Acid Hydrochloride (ALA) market was valued at USD 89.04 million in 2022[1].

What is the projected CAGR for the ALA market from 2022 to 2030?

The ALA market is expected to grow at a CAGR of 7.29% from 2022 to 2030[1][2].

Which region dominates the ALA market?

North America is the largest market for ALA, holding a market share of 36.66% in 2022[1][2].

What are the primary applications of ALA?

ALA is primarily used in the pharmaceutical sector for cancer diagnosis and treatment, particularly in photodynamic therapy, and also as a growth regulator in plants[1][2].

What are the main challenges facing the ALA market?

The main challenges include economic slowdown affecting R&D investments and high costs associated with research and development[1][2].

Sources

1. The Brainy Insights: 5-Aminolevulinic Acid Hydrochloride (ALA) Market Report[1].
2. GlobeNewswire: 5-Aminolevulinic Acid Hydrochloride (ALA) Market Size to Reach USD 159.58 Million by 2030[2].
3. Synapse by Patsnap: Aminolevulinic Acid Hydrochloride - Drug Targets, Indications, Patents[3].