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Last Updated: December 23, 2024

AMINOLEVULINIC ACID HYDROCHLORIDE - Generic Drug Details


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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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AMINOLEVULINIC ACID HYDROCHLORIDE
Generic Entry Dates for AMINOLEVULINIC ACID HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;TOPICAL
Generic Entry Dates for AMINOLEVULINIC ACID HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Lee's Pharmaceutical LimitedPhase 3
National Heart, Lung, and Blood Institute (NHLBI)Phase 1/Phase 2
University of ZurichEarly Phase 1

See all AMINOLEVULINIC ACID HYDROCHLORIDE clinical trials

Pharmacology for AMINOLEVULINIC ACID HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for AMINOLEVULINIC ACID HYDROCHLORIDE

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 ⤷  Subscribe ⤷  Subscribe
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 RX Yes Yes 11,235,169 ⤷  Subscribe ⤷  Subscribe
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 RX Yes Yes 11,540,981 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Subscribe
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 6,559,183 ⤷  Subscribe
Sun Pharm Inds Inc LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 8,758,418 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AMINOLEVULINIC ACID HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Australia 2021102111 Methods for photodynamic therapy ⤷  Subscribe
Canada 3029792 METHODES DE THERAPIE PHOTODYNAMIQUE (METHODS FOR PHOTODYNAMIC THERAPY) ⤷  Subscribe
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) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

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].

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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 verification 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.