CROMOLYN SODIUM - Generic Drug Details

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

Cromolyn sodium is the generic ingredient in seven branded drugs marketed by King Pharms Llc, Sanofi Aventis Us, Ucb Inc, Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising, Mylan Speciality Lp, Bausch And Lomb, Apotex Inc, Sandoz, Sciegen Pharms Inc, King Pharms, Allergan, Actavis Mid Atlantic, Bausch, Eugia Pharma, Hikma, Micro Labs, Roxane, Teva Pharms, Virtus, Watson Labs, Wockhardt Bio Ag, Hh And P, Perrigo, and Blacksmith Brands, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for cromolyn sodium. Eighteen suppliers are listed for this compound.

Summary for CROMOLYN SODIUM

US Patents:	0
Tradenames:	7
Applicants:	27
NDAs:	31
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	23
Patent Applications:	8,076
What excipients (inactive ingredients) are in CROMOLYN SODIUM?	CROMOLYN SODIUM excipients list
DailyMed Link:	CROMOLYN SODIUM at DailyMed

Recent Clinical Trials for CROMOLYN SODIUM

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

Sponsor	Phase
Adli Karadsheh, MD, MS	Phase 3
Texas Tech University Health Sciences Center, El Paso	Phase 3
APCER	Phase 2

See all CROMOLYN SODIUM clinical trials

Pharmacology for CROMOLYN SODIUM

Drug Class	Mast Cell Stabilizer
Physiological Effect	Decreased Histamine Release

Medical Subject Heading (MeSH) Categories for CROMOLYN SODIUM

Anti-Asthmatic Agents

US Patents and Regulatory Information for CROMOLYN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Mid Atlantic	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	075067-001	Jul 19, 1999		DISCN	No	No
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984		DISCN	Yes	No
Ailex Pharms Llc	CROMOLYN SODIUM	cromolyn sodium	CONCENTRATE;ORAL	209264-001	Oct 16, 2017	AA	RX	No	No
Roxane	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	075175-001	Sep 30, 1999		DISCN	No	No
King Pharms	CROMOPTIC	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	075088-001	Apr 27, 1999		DISCN	No	No
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982		DISCN	Yes	No

Expired US Patents for CROMOLYN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982	3,957,965
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984	3,975,536
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982	3,975,536
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984	3,419,578
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982	3,419,578
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982	3,860,618

CROMOLYN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cromolyn Sodium

Market Overview

Cromolyn sodium, a versatile drug with a wide range of applications, is experiencing significant growth in the global market. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global Cromolyn Sodium API market has been expanding steadily. As of 2023, the market size was notable, and it is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2031[1].

Key Applications

Cromolyn sodium is used in various therapeutic areas, including:

Respiratory Diseases

• It is widely used in the treatment of chronic mild to moderately severe asthma. Including cromolyn sodium in anti-asthma regimens has been shown to reduce emergency room visits and hospital admissions significantly, leading to cost savings[2].

Allergic Conditions

• Cromolyn sodium is effective in treating allergies, inflammatory responses, and mast cell activation. It is administered through various formulations such as capsules, liquids, gels, ointments, creams, solutions, and suspensions for oral, mucosal, nasal, and topical use[3].

Atopic Dermatitis

• The drug has been successfully used to treat atopic dermatitis, with formulations like 4% cromolyn sodium creams showing significant improvements in disease symptoms and quality of life for patients[5].

Gastrointestinal Diseases

• It is also used in the treatment of Crohn’s disease, ulcerative colitis, and irritable bowel syndrome (IBS), with oral capsules and enemas being common administration methods[3].

Market Segmentation

The market is segmented based on type and application:

Type

• The purity levels of cromolyn sodium, such as above 98%, are significant segments. The above 98% purity segment accounted for a noticeable share of the global market in 2023 and is expected to experience significant growth[1].

Application

• Eye drops are a major application segment, expected to expand at a significant CAGR throughout the forecast period. Other applications include respiratory, allergic conditions, and dermatological treatments[1].

Market Drivers

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

Increasing Demand for High-Quality Chemicals

• The demand for high-quality and environmentally friendly products is rising in various end-use sectors, including pharmaceuticals, personal care, and consumer goods. This trend is pushing manufacturers to focus on technological advancements in chemical production[1].

Therapeutic Efficacy

• Cromolyn sodium’s effectiveness in treating various conditions, such as asthma, allergies, and atopic dermatitis, is a significant driver. Its ability to inhibit mast cell activation and reduce histamine release makes it a valuable therapeutic option[3][5].

Cost-Effectiveness

• Including cromolyn sodium in treatment plans has been shown to reduce healthcare costs by decreasing the need for emergency room visits and hospital admissions. This cost-effectiveness is an attractive factor for both patients and healthcare providers[2].

Market Restraints

Despite the growth, there are some challenges:

Physiochemical Properties

• Cromolyn sodium’s large molecular weight, high ionizability, and hydrophilicity pose challenges for skin permeation, which can limit its effectiveness in topical applications. Overcoming these properties requires the use of various enhancements to improve drug delivery[5].

Regulatory Considerations

• The inclusion of cromolyn sodium in regulatory lists, such as the 503B Bulks List, can be subject to detailed reviews and nominations. This process can be time-consuming and may affect market availability[3].

Competitive Landscape

The market is competitive with several key players:

Major Manufacturers

• Companies like Cambrex and JSN Chemicals are focusing on strategy building and expanding their product portfolios to strengthen their market position[1].

Regional Analysis

• The market is analyzed regionally, with North America, Europe, Asia Pacific, South America, and the Middle East and Africa being key regions. Each region has its own market size and growth projections[1].

Financial Trajectory

The financial trajectory of the cromolyn sodium market is promising:

Cost Savings

• The inclusion of cromolyn sodium in treatment plans can lead to significant cost savings. For instance, it reduced the average cost of emergency room visits from $624 to $33 per year and hospital admissions by $1,298 compared to a control group[2].

Market Forecast

• The global market size is expected to grow from 2024 to 2031, driven by increasing demand and therapeutic efficacy. The forecast period indicates a positive CAGR, making it an attractive market for investors[1].

Revenue and Volume Share

• The market report provides detailed insights into revenue and volume share, helping stakeholders understand the market’s financial health and growth potential[1].

Technological Trends

Technological advancements are crucial for the market:

Manufacturing Process

• The report includes a detailed analysis of the manufacturing process and major raw materials required, which helps in understanding the production costs and efficiency[1].

Drug Delivery Enhancements

• Various enhancements are being developed to improve the delivery of cromolyn sodium, especially for topical applications. These include transdermal drug delivery systems to overcome the drug’s physiochemical limitations[5].

Consumer Behavior and Market Attractiveness

Consumer behavior and market attractiveness are key factors:

Consumer Behavior Analysis

• The market report includes an analysis of consumer behavior, which helps in understanding the preferences and needs of the end-users. This information is crucial for marketing strategies and product positioning[1].

Market Attractiveness

• The report provides a market attractiveness analysis, which helps in identifying the most lucrative segments and regions. This analysis is based on factors such as market size, growth rate, and competitive landscape[1].

Key Takeaways

• Growing Demand: The demand for cromolyn sodium is increasing due to its therapeutic efficacy and cost-effectiveness.
• Market Segmentation: The market is segmented by type and application, with eye drops and above 98% purity segments being significant.
• Cost Savings: Including cromolyn sodium in treatment plans can lead to significant cost savings.
• Technological Advancements: Improvements in manufacturing and drug delivery systems are crucial for market growth.
• Competitive Landscape: Major manufacturers are focusing on expanding their product portfolios and market presence.

FAQs

Q: What are the primary applications of cromolyn sodium?

A: Cromolyn sodium is primarily used in the treatment of respiratory diseases like asthma, allergic conditions, atopic dermatitis, and gastrointestinal diseases such as Crohn’s disease and IBS.

Q: How does cromolyn sodium reduce healthcare costs?

A: Cromolyn sodium reduces healthcare costs by decreasing the number of emergency room visits and hospital admissions, thereby lowering the overall cost of treatment.

Q: What are the challenges in topical applications of cromolyn sodium?

A: The drug’s large molecular weight, high ionizability, and hydrophilicity pose challenges for skin permeation, requiring the use of various enhancements to improve delivery.

Q: Which companies are key players in the cromolyn sodium market?

A: Companies like Cambrex and JSN Chemicals are major players, focusing on strategy building and expanding their product portfolios.

Q: What is the forecasted growth rate of the cromolyn sodium market?

A: The market is expected to grow at a significant CAGR from 2024 to 2031, driven by increasing demand and therapeutic efficacy.

Sources

1. Cromolyn Sodium API Market Report 2024 (Global Edition) - Cognitive Market Research
2. Cost-effectiveness of including cromolyn sodium in the treatment of asthma - PubMed
3. Cromolyn sodium - University of Maryland, Baltimore
4. Cromolyn Sodium Market Growth | (2024-2032) - Southeast News Channel Nebraska
5. Effect of Chemical and Physical Enhancers on the Skin Permeation of Cromolyn Sodium - East Tennessee State University