Balsalazide disodium - Generic Drug Details

What are the generic drug sources for balsalazide disodium and what is the scope of patent protection?

Balsalazide disodium is the generic ingredient in three branded drugs marketed by Apotex Inc, Dash Pharms Natco, Hikma, Zydus Lifesciences, Valeant Pharms Intl, and Strides Pharma, and is included in seven NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Balsalazide disodium has forty-five patent family members in twelve countries.

There are ten drug master file entries for balsalazide disodium. Nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for balsalazide disodium

International Patents:	45
US Patents:	6
Tradenames:	3
Applicants:	6
NDAs:	7
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	221
Clinical Trials:	7
Patent Applications:	3,589
Drug Prices:	Drug price trends for balsalazide disodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for balsalazide disodium
What excipients (inactive ingredients) are in balsalazide disodium?	balsalazide disodium excipients list
DailyMed Link:	balsalazide disodium at DailyMed

See drug prices for balsalazide disodium

Recent Clinical Trials for balsalazide disodium

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

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 3
Bausch Health Americas, Inc.	Phase 3
Roxane Laboratories	N/A

See all balsalazide disodium clinical trials

Generic filers with tentative approvals for BALSALAZIDE DISODIUM

Applicant	Application No.	Strength	Dosage Form
		1.1GM	TABLET;ORAL
		1.1G	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for balsalazide disodium

Drug Class

Aminosalicylate

Anatomical Therapeutic Chemical (ATC) Classes for balsalazide disodium

A07EC	Aminosalicylic acid and similar agents
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for BALSALAZIDE DISODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COLAZAL	Capsules	balsalazide disodium	750 mg	020610	1	2022-05-26
GIAZO	Tablets	balsalazide disodium	1.1 g	022205	1	2013-11-05

US Patents and Regulatory Information for balsalazide disodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Lifesciences	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	217592-001	Jun 8, 2023	AB	RX	No	No
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	AB	RX	Yes	Yes	7,452,872*PED				Y
Apotex Inc	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077883-001	Dec 28, 2007	AB	RX	No	No
Strides Pharma	BALSALAZIDE DISODIUM	balsalazide disodium	TABLET;ORAL	206336-001	Sep 8, 2015		DISCN	No	No

Expired US Patents for balsalazide disodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	4,412,992*PED
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012	6,197,341

International Patents for balsalazide disodium

Country	Patent Number	Title	Estimated Expiration
China	101610670	Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Japan	2013525440
China	101247812	Balsalazide formulations and manufacture and use thereof
New Zealand	593132	BALSALAZIDE FORMULATIONS AND MANUFACTURE AND USE THEREOF

Balsalazide disodium Market Analysis and Financial Projection Experimental

Balsalazide Disodium: Market Dynamics and Financial Trajectory

Introduction to Balsalazide Disodium

Balsalazide disodium is an anti-inflammatory medication used primarily to treat mildly to moderately active ulcerative colitis, a condition characterized by swelling and sores in the lining of the colon and rectum. Here, we delve into the market dynamics and financial trajectory of this drug.

Mechanism of Action and Clinical Use

Balsalazide disodium works as a prodrug, delivering mesalazine (5-aminosalicylic acid) directly to the large intestine where it is enzymatically cleaved by bacterial azoreduction. This targeted delivery minimizes systemic absorption and maximizes therapeutic efficacy in treating ulcerative colitis[5].

Market Dynamics

Drivers of Growth

• Rising Prevalence of Ulcerative Colitis: The increasing incidence of inflammatory bowel diseases (IBD), particularly ulcerative colitis, is a significant driver of the balsalazide market. This trend is more pronounced in wealthy nations where healthcare access and awareness are higher[3].
• Technological Advancements: Improvements in pharmaceutical formulations and administration methods enhance treatment outcomes and patient compliance, contributing to market growth[3].
• Growing Awareness of Gastrointestinal Health: Increased awareness about the importance of early diagnosis and treatment of gastrointestinal disorders is driving demand for balsalazide[3].

Restraints and Challenges

• Side Effects: Despite its efficacy, balsalazide can have side effects, which may hamper market growth. Common adverse effects include gastrointestinal issues and other reactions that could deter some patients[1][5].
• Limited Efficacy in Certain Populations: Clinical studies have shown that balsalazide's effectiveness is not consistent across all patient groups, particularly in female patients, which can limit its market potential[2].

Market Segmentation

By Dosage Form

The balsalazide market is segmented into tablets and capsules. Each form has its own advantages and patient preferences, contributing to the overall market size. For instance, the tablet formulation of balsalazide disodium, such as Giazo, is dosed twice daily and has specific indications and usage guidelines[2].

By Distribution Channel

The market is also segmented by distribution channels, including hospitals, retail channels, and online pharmacies. This segmentation highlights the various pathways through which balsalazide is accessed by patients, influencing market dynamics and revenue streams[1][3].

Regional Framework

The global balsalazide market is analyzed across several regions:

• North America: This region is a significant market due to high healthcare spending and advanced healthcare infrastructure.
• Europe: Similar to North America, Europe has a well-developed healthcare system and a high incidence of IBD.
• Asia-Pacific: This region is expected to grow rapidly due to increasing healthcare awareness and improving healthcare infrastructure.
• Middle East and Africa: These regions are also seeing growth, driven by rising healthcare accessibility and awareness.
• South and Central America: These regions are emerging markets with potential for growth in the balsalazide sector[1][3].

Financial Trajectory

Current Market Size and Forecast

As of 2023, the global balsalazide market was valued at approximately USD 100 billion. It is projected to reach USD 194.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 10% from 2024 to 2031[3].

Revenue Projections

The market is expected to witness significant growth driven by the factors mentioned above. Here are some key financial projections:

• Market Size by 2031: USD 194.5 billion
• CAGR (2024-2031): 10%
• Historical Data: The market has shown steady growth from 2021 to 2023, setting the stage for continued expansion[3].

Market Players and Strategies

Key Players

Several companies are active in the balsalazide market, including:

• PD-Rx Pharmaceuticals, Inc.
• Oceanside Pharmaceuticals
• AvKARE, LLC.
• Apotex Corp.
• Salix Pharmaceuticals, Inc.
• Sun Pharma
• Intas Pharmaceuticals Ltd
• Torrent Pharma

These companies are focusing on organic growth strategies such as product launches, product approvals, and inorganic strategies like acquisitions and partnerships to expand their market presence[1].

Competitive Landscape

The competitive landscape is characterized by intense competition among market players. Companies are investing in research and development to improve treatment regimens for IBD and enhance patient compliance. The report includes detailed profiles of key players, their market strategies, and SWOT analyses[1][3].

Technological and Research Advancements

Improvements in Formulations

Technological advancements in pharmaceutical formulations are enhancing the efficacy and patient compliance of balsalazide. These improvements include better delivery mechanisms that ensure the drug reaches the colon intact, where it can be enzymatically cleaved to release the active ingredient, mesalamine[5].

Ongoing Research

Continuous research and development efforts are aimed at improving treatment outcomes for IBD. These efforts include studies on new formulations, dosing regimens, and combination therapies that could further expand the market for balsalazide[3].

Regulatory Environment

FDA Approvals and Guidelines

The FDA has played a crucial role in the approval process of balsalazide products. For instance, the approval of Giazo was contingent upon additional clinical studies to demonstrate its efficacy in treating mildly to moderately active ulcerative colitis in male patients. The regulatory environment continues to influence the market dynamics, with strict guidelines ensuring the safety and efficacy of balsalazide products[2].

PEST Analysis

Political Factors

Regulatory policies and healthcare reforms significantly impact the balsalazide market. Changes in healthcare policies can affect the availability and affordability of the drug.

Economic Factors

Economic factors such as healthcare spending, insurance coverage, and the overall economic health of regions influence the market size and growth.

Social Factors

Increasing awareness about gastrointestinal health and the importance of early diagnosis and treatment drive demand for balsalazide.

Technological Factors

Advancements in pharmaceutical technology and healthcare infrastructure are key drivers of the market[1].

"The growing prevalence of inflammatory bowel diseases (IBD), such as ulcerative colitis, which calls for efficient treatment choices, is one of the major factors propelling the balsalazide market." - Market Research Intellect[3]

Key Takeaways

• The balsalazide market is driven by the rising prevalence of ulcerative colitis and technological advancements in pharmaceutical formulations.
• The market is segmented by dosage form (tablets and capsules) and distribution channels (hospitals, retail, and online pharmacies).
• The global market is expected to grow at a CAGR of 10% from 2024 to 2031, reaching USD 194.5 billion by 2031.
• Key players are focusing on organic and inorganic growth strategies to expand their market presence.
• Regulatory approvals and ongoing research are crucial for the market's growth and expansion.

FAQs

What is the primary use of balsalazide disodium?

Balsalazide disodium is primarily used to treat mildly to moderately active ulcerative colitis, delivering mesalazine directly to the large intestine.

Which regions are expected to drive the growth of the balsalazide market?

North America, Europe, and the Asia-Pacific region are expected to be significant drivers of the balsalazide market due to high healthcare spending and increasing awareness of gastrointestinal health.

What are the key growth drivers of the balsalazide market?

The key growth drivers include the rising prevalence of ulcerative colitis, technological advancements in pharmaceutical formulations, and growing awareness of gastrointestinal health.

Which companies are major players in the balsalazide market?

Major players include PD-Rx Pharmaceuticals, Inc., Oceanside Pharmaceuticals, AvKARE, LLC., Apotex Corp., Salix Pharmaceuticals, Inc., and others.

What is the projected CAGR of the balsalazide market from 2024 to 2031?

The balsalazide market is projected to grow at a CAGR of 10% from 2024 to 2031.

Sources

1. The Insight Partners, "Balsalazide Market Strategies and Share 2031"
2. FDA, "022205Orig1s000 - accessdata.fda.gov"
3. Market Research Intellect, "Global balsalazide market size and forecast"
4. Dataintelo, "Balsalazide Disodium Market Research Report 2032"
5. DrugBank, "Balsalazide: Uses, Interactions, Mechanism of Action"