NEDOCROMIL SODIUM - Generic Drug Details

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

Nedocromil sodium is the generic ingredient in three branded drugs marketed by King Pharms Llc, Allergan, Epic Pharma Llc, and Sanofi Aventis Us, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for nedocromil sodium. One supplier is listed for this compound.

Summary for NEDOCROMIL SODIUM

US Patents:	0
Tradenames:	3
Applicants:	4
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	7
Patent Applications:	5,897
What excipients (inactive ingredients) are in NEDOCROMIL SODIUM?	NEDOCROMIL SODIUM excipients list
DailyMed Link:	NEDOCROMIL SODIUM at DailyMed

Recent Clinical Trials for NEDOCROMIL SODIUM

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

Sponsor	Phase
Indiana University	Phase 4
Childhood Asthma Research and Education Network	Phase 3
Imperial College London	Phase 2

See all NEDOCROMIL SODIUM clinical trials

Pharmacology for NEDOCROMIL SODIUM

Drug Class	Mast Cell Stabilizer
Physiological Effect	Decreased Histamine Release

Medical Subject Heading (MeSH) Categories for NEDOCROMIL SODIUM

Anti-Allergic Agents

Anti-Asthmatic Agents

Anti-Inflammatory Agents

Anatomical Therapeutic Chemical (ATC) Classes for NEDOCROMIL SODIUM

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BC	Antiallergic agents, excl. corticosteroids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for NEDOCROMIL SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	TILADE	nedocromil sodium	SOLUTION;INHALATION	020750-001	Oct 1, 1997		DISCN	No	No
King Pharms Llc	TILADE	nedocromil sodium	AEROSOL, METERED;INHALATION	019660-001	Dec 30, 1992		DISCN	No	No
Epic Pharma Llc	NEDOCROMIL SODIUM	nedocromil sodium	SOLUTION/DROPS;OPHTHALMIC	090638-001	Aug 22, 2012		DISCN	No	No
Allergan	ALOCRIL	nedocromil sodium	SOLUTION/DROPS;OPHTHALMIC	021009-001	Dec 8, 1999		DISCN	Yes	No

Expired US Patents for NEDOCROMIL SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ALOCRIL	nedocromil sodium	SOLUTION/DROPS;OPHTHALMIC	021009-001	Dec 8, 1999
King Pharms Llc	TILADE	nedocromil sodium	AEROSOL, METERED;INHALATION	019660-001	Dec 30, 1992
Allergan	ALOCRIL	nedocromil sodium	SOLUTION/DROPS;OPHTHALMIC	021009-001	Dec 8, 1999
Allergan	ALOCRIL	nedocromil sodium	SOLUTION/DROPS;OPHTHALMIC	021009-001	Dec 8, 1999

NEDOCROMIL SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nedocromil Sodium

Introduction

Nedocromil sodium, a pyranoquinoline derivative, is widely recognized for its anti-inflammatory properties, particularly in the treatment of asthma and allergic conjunctivitis. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global market for nedocromil sodium has shown significant growth over the years. As of 2023, the market size was valued at approximately USD 1.2 billion. Projections indicate that this market is expected to expand, reaching USD 2.1 billion by 2032[4].

Market Drivers

Several factors drive the growth of the nedocromil sodium market:

Increasing Prevalence of Asthma and Allergies

The rising incidence of asthma and allergic conditions globally has increased the demand for effective anti-inflammatory medications like nedocromil sodium. This trend is expected to continue, fueling market growth[5].

Therapeutic Efficacy

Nedocromil sodium has been proven to be effective in preventing asthma symptoms and reducing the severity of asthma attacks when used regularly. Its ability to inhibit the activation of various inflammatory cells and the release of mediators associated with asthma makes it a valuable treatment option[1][3].

Adjunctive Therapy

The drug is often used as an adjunct to other asthma medications, such as bronchodilators and corticosteroids. This multi-faceted approach to asthma management further boosts the demand for nedocromil sodium[5].

Market Challenges

Despite the growth potential, the market for nedocromil sodium faces several challenges:

Withdrawal from Certain Markets

In 2008, inhalation products containing nedocromil were withdrawn from the U.S. market by King Pharmaceuticals, which could have temporarily impacted sales and market presence[5].

Side Effects and Adverse Reactions

While generally well-tolerated, nedocromil sodium can cause side effects such as throat irritation, unpleasant taste, and in some cases, increased wheezing or difficulty in breathing. These side effects may deter some patients and affect market dynamics[5].

Competitive Landscape

The market for anti-asthma and anti-allergic medications is highly competitive, with several other drugs and therapies available. Nedocromil sodium competes with other mast cell stabilizers and anti-inflammatory agents, such as cromolyn disodium and lodoxamide[2].

Regulatory Environment

The regulatory status of nedocromil sodium varies by region. It is approved and available in several global markets, but its availability and marketing status can change based on local regulatory decisions. For instance, the withdrawal from the U.S. market highlights the importance of regulatory approvals in shaping market dynamics[5].

Financial Performance

The financial performance of nedocromil sodium is closely tied to its market size and growth. With a projected market size of USD 2.1 billion by 2032, the financial trajectory looks promising. Here are some key financial indicators:

Revenue Growth

The revenue from nedocromil sodium is expected to grow steadily, driven by increasing demand and expanding market reach.

Cost and Pricing

The cost of nedocromil sodium products can vary by region and formulation. For example, the ophthalmic solution can range from USD 19.34 per mL to USD 100.57 per 5ml bottle, depending on the brand and region[1].

Future Outlook

The future outlook for nedocromil sodium is positive, driven by its therapeutic efficacy and the growing need for effective asthma and allergy treatments. Here are some key points to consider:

Expanding Indications

Research into new indications and uses for nedocromil sodium could further expand its market potential. For instance, its use in treating other inflammatory conditions could open up new revenue streams.

Generic and Branded Products

The availability of both generic and branded products of nedocromil sodium helps in catering to a broader market, including cost-sensitive consumers. This diversification can help in sustaining market growth[1].

Key Takeaways

• The global nedocromil sodium market is projected to grow significantly, reaching USD 2.1 billion by 2032.
• The drug's efficacy in preventing asthma symptoms and its use as an adjunct to other treatments drive market demand.
• Despite challenges such as side effects and market withdrawals, the overall financial trajectory remains positive.
• The competitive landscape and regulatory environment play crucial roles in shaping market dynamics.

FAQs

Q: What is nedocromil sodium used for? A: Nedocromil sodium is used to prevent the symptoms of asthma and to treat allergic conjunctivitis. It works by inhibiting the activation of inflammatory cells and the release of mediators associated with asthma[1][5].

Q: Why was nedocromil sodium withdrawn from the U.S. market? A: Inhalation products containing nedocromil sodium were withdrawn from the U.S. market by King Pharmaceuticals in 2008, although the exact reasons are not specified in available sources[5].

Q: What are the common side effects of nedocromil sodium? A: Common side effects include throat irritation, unpleasant taste, dryness or soreness of the throat, and in some cases, increased wheezing or difficulty in breathing[5].

Q: Can nedocromil sodium be used with other asthma medications? A: Yes, nedocromil sodium is often used as an adjunct to other asthma medications, such as bronchodilators and corticosteroids[5].

Q: What is the projected market size of nedocromil sodium by 2032? A: The global market for nedocromil sodium is projected to reach USD 2.1 billion by 2032[4].

Cited Sources:

1. DrugBank: Nedocromil - Uses, Interactions, Mechanism of Action.
2. ACS Pharmacol. Transl. Sci.: Therapeutic Opportunities and Challenges in Targeting the Orphan G Protein-Coupled Receptor GPR35.
3. PubMed: Nedocromil sodium. An updated review of its pharmacological properties and therapeutic efficacy.
4. Dataintelo: Nedocromil Sodium Market Research Report 2032.
5. Mayo Clinic: Nedocromil (inhalation route) - Description.