Aminosalicylate sodium - Generic Drug Details

What are the generic sources for aminosalicylate sodium and what is the scope of patent protection?

Aminosalicylate sodium is the generic ingredient in six branded drugs marketed by Century Pharms, Hexcel, Panray, Lannett, Consolidated Midland, and Medpointe Pharm Hlc, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for aminosalicylate sodium.

Summary for aminosalicylate sodium

US Patents:	0
Tradenames:	6
Applicants:	6
NDAs:	6
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	329
Clinical Trials:	1
Patent Applications:	6,564
DailyMed Link:	aminosalicylate sodium at DailyMed

Recent Clinical Trials for aminosalicylate sodium

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

Sponsor	Phase
Beijing Chest Hospital	N/A

See all aminosalicylate sodium clinical trials

US Patents and Regulatory Information for aminosalicylate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Panray	PARASAL SODIUM	aminosalicylate sodium	TABLET;ORAL	006811-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Lannett	SODIUM P.A.S.	aminosalicylate sodium	TABLET;ORAL	080138-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Century Pharms	P.A.S. SODIUM	aminosalicylate sodium	POWDER;ORAL	080947-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Medpointe Pharm Hlc	NEOPASALATE	aminosalicylate sodium; aminosalicylic acid	TABLET;ORAL	080059-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Panray	PARASAL SODIUM	aminosalicylate sodium	TABLET;ORAL	006811-011	Approved Prior to Jan 1, 1982		DISCN	No	No

Aminosalicylate sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aminosalicylate Sodium

Introduction

Aminosalicylate sodium, a derivative of aminosalicylic acid, is a medication used in the treatment of various conditions, including tuberculosis and inflammatory bowel diseases like ulcerative colitis and Crohn's disease. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global market for aminosalicylate sodium and related compounds, such as 5-aminosalicylates (5-ASAs), is experiencing significant growth. The global aminosalicylate sodium market was valued at $456 million in 2023 and is projected to reach $763 million by 2032, growing at a compound annual growth rate (CAGR)[1].

Market Drivers

Several factors are driving the growth of the aminosalicylate sodium market:

Increasing Prevalence of Inflammatory Bowel Diseases

The rising number of patients with ulcerative colitis and Crohn's disease is a major driver. In the United States, over 1.6 million individuals are affected by inflammatory bowel disease (IBD), with approximately 70,000 new cases diagnosed annually[3].

Government Initiatives and Healthcare Advancements

Government measures to improve healthcare infrastructure and advancements in diagnostic and therapeutic technologies are also contributing to market growth. These initiatives enhance the accessibility and effectiveness of treatments, including those involving aminosalicylate sodium[3].

Regional Healthcare Practices

North America dominates the global market due to better healthcare practices, high treatment rates, and increased prescription of novel medicines. The presence of strong market participants and strategic actions in this region further boost the market[3].

Market Segmentation

The global 5-aminosalicylates drugs market, which includes aminosalicylate sodium, is segmented based on type and indication:

Type

The market is segmented into sulfasalazine, mesalazine, olsalazine, and others. Mesalazine, also known as mesalamine, is a key player in this segment due to its widespread use in treating ulcerative colitis and other inflammatory bowel diseases[3].

Indication

The market is primarily driven by the treatment of ulcerative colitis, which holds the largest revenue share. Other indications include inflammatory bowel disease and other gastrointestinal conditions[3].

Competitive Landscape

The market for aminosalicylate sodium and related 5-ASAs is competitive, with several key players:

• Tillotts Pharma AG
• Wallace Pharma
• Takeda Pharmaceutical Company Limited
• Abbvie, Inc.
• Cosmo Pharmaceuticals NV

These companies are involved in the development, manufacturing, and marketing of various 5-ASA formulations[3].

Financial Trajectory

The financial trajectory of the aminosalicylate sodium market is promising, with several key indicators:

Revenue Growth

The market is expected to grow at a CAGR of around 3.5% from 2023 to 2031. This growth is driven by the increasing prevalence of IBD and the introduction of new medications and formulations[3].

Regional Revenue

North America holds the largest revenue share due to advanced healthcare practices and a high number of prescriptions for novel medicines. Other regions, such as Europe and Asia Pacific, are also expected to contribute significantly to the market growth[3].

Pharmacokinetics and Clinical Use

Aminosalicylate sodium, particularly in the form of mesalamine, has specific pharmacokinetic properties that influence its clinical use:

Absorption and Distribution

Mesalamine, a form of aminosalicylate, is released in the terminal ileum due to its pH-dependent polymer coating. This delayed release ensures that the drug acts locally in the intestines, reducing systemic side effects. The drug's absorption is affected by factors such as food intake, with high-fat meals delaying absorption but increasing systemic exposure[2].

Clinical Indications

Aminosalicylate sodium is used in the treatment of tuberculosis, often in combination with other anti-TB drugs. For IBD, it is used to induce and maintain remission in patients with mild to moderate ulcerative colitis[5].

Side Effects and Precautions

While aminosalicylate sodium is generally well-tolerated, it can cause side effects such as diarrhea, loss of appetite, nausea, and stomach pain. It is crucial to follow the prescribed dosage and avoid taking the drug within 6 hours of rifampin to ensure efficacy and safety[5].

Key Takeaways

• The global aminosalicylate sodium market is projected to grow significantly, driven by the increasing prevalence of IBD and advancements in healthcare.
• North America dominates the market due to better healthcare practices and high treatment rates.
• The market is segmented by type and indication, with ulcerative colitis being the primary indication.
• Key players include Tillotts Pharma AG, Takeda Pharmaceutical Company Limited, and Abbvie, Inc.
• The drug's pharmacokinetics and clinical use are critical in its effectiveness and safety.

FAQs

1. What is the primary use of aminosalicylate sodium? Aminosalicylate sodium is primarily used in the treatment of tuberculosis and inflammatory bowel diseases such as ulcerative colitis and Crohn's disease[5].

2. How is the global aminosalicylate sodium market expected to grow? The global aminosalicylate sodium market is expected to grow at a CAGR of around 3.5% from 2023 to 2031, reaching $763 million by 2032[1][3].

3. Which region dominates the global 5-aminosalicylates drugs market? North America dominates the global 5-aminosalicylates drugs market due to better healthcare practices, high treatment rates, and increased prescription of novel medicines[3].

4. What are the common side effects of aminosalicylate sodium? Common side effects include diarrhea, loss of appetite, nausea, and stomach pain. Less common side effects may include changes in menstrual periods, decreased sexual ability in males, and dry, puffy skin[5].

5. How does food intake affect the absorption of mesalamine? High-fat meals can delay the absorption of mesalamine but increase its systemic exposure. It is advisable to take the drug with or after meals or with an antacid if it upsets the stomach[2].

Cited Sources:

1. Dataintelo. Aminosalicylate Sodium Market Research Report 2032 - Dataintelo.
2. FDA. LIALDA (Mesalamine), - accessdata.fda.gov.
3. GlobeNewswire. 5-Aminosalicylates Drugs Market Is Projected to increase at a CAGR of around 3.5% during 2023 to 2031: Exclusive report by Growth Plus Reports.
4. News Channel Nebraska. Aminosalicylate Sodium Market: Key Players, Applications, and Future Prospects.
5. Mayo Clinic. Aminosalicylate sodium (oral route) - Mayo Clinic.