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Last Updated: December 26, 2024

CROMOLYN SODIUM Drug Patent Profile


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Which patents cover Cromolyn Sodium, and when can generic versions of Cromolyn Sodium launch?

Cromolyn Sodium is a drug marketed by Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising, Apotex Inc, Sandoz, Sciegen Pharms Inc, Actavis Mid Atlantic, Bausch, Eugia Pharma, Hikma, Micro Labs, Roxane, Teva Pharms, Virtus, Watson Labs, Wockhardt Bio Ag, Bausch And Lomb, Hh And P, and Perrigo. and is included in twenty-two NDAs.

The generic ingredient in CROMOLYN SODIUM is cromolyn sodium. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cromolyn Sodium

A generic version of CROMOLYN SODIUM was approved as cromolyn sodium by SANDOZ on June 16th, 1999.

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Summary for CROMOLYN SODIUM
US Patents:0
Applicants:20
NDAs:22
Finished Product Suppliers / Packagers: 16
Raw Ingredient (Bulk) Api Vendors: 76
Clinical Trials: 23
Patent Applications: 4,783
What excipients (inactive ingredients) are in CROMOLYN SODIUM?CROMOLYN SODIUM excipients list
DailyMed Link:CROMOLYN SODIUM at DailyMed
Drug patent expirations by year for CROMOLYN SODIUM
Recent Clinical Trials for CROMOLYN SODIUM

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

SponsorPhase
Texas Tech University Health Sciences Center, El PasoPhase 3
Adli Karadsheh, MD, MSPhase 3
MedAvantePhase 2

See all CROMOLYN SODIUM clinical trials

Pharmacology for CROMOLYN SODIUM
Drug ClassMast Cell Stabilizer
Physiological EffectDecreased Histamine Release
Medical Subject Heading (MeSH) Categories for CROMOLYN SODIUM

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
Ailex Pharms Llc CROMOLYN SODIUM cromolyn sodium CONCENTRATE;ORAL 209264-001 Oct 16, 2017 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wockhardt Bio Ag CROMOLYN SODIUM cromolyn sodium SOLUTION;INHALATION 075346-001 Oct 25, 1999 AN RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sciegen Pharms Inc CROMOLYN SODIUM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 074706-001 Apr 29, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising CROMOLYN SODIUM cromolyn sodium CONCENTRATE;ORAL 202583-001 Oct 27, 2011 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma CROMOLYN SODIUM cromolyn sodium SOLUTION;INHALATION 075333-001 Apr 30, 2002 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch And Lomb CROMOLYN SODIUM cromolyn sodium SPRAY, METERED;NASAL 075702-001 Jul 3, 2001 OTC No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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