INTAL Drug Patent Profile

When do Intal patents expire, and what generic alternatives are available?

Intal is a drug marketed by King Pharms Llc and Sanofi Aventis Us and is included in three NDAs.

The generic ingredient in INTAL 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 Intal

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

Summary for INTAL

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	98
Patent Applications:	3,605
DailyMed Link:	INTAL at DailyMed

US Patents and Regulatory Information for INTAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms Llc	INTAL	cromolyn sodium	AEROSOL, METERED;INHALATION	018887-001	Dec 5, 1985		DISCN	No	No
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982		DISCN	Yes	No

Expired US Patents for INTAL

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
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982
King Pharms Llc	INTAL	cromolyn sodium	AEROSOL, METERED;INHALATION	018887-001	Dec 5, 1985
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982

International Patents for INTAL

See the table below for patents covering INTAL around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	7202823
Malaysia	7400330	PHARMACEUTICAL COMPOSITION
Italy	1158890	DISPERSIONI O SOSPENSIONI DI LECITINA O DI UN ESTERE DI SORBITANO O SORBITOLO IN UNA MISCELA PROPELLENTE PRIVA DI TRICLOROMONOFLUOROMETANO
United Kingdom	1473318
Australia	465305
Germany	1920365

INTAL Market Analysis and Financial Projection Experimental

Inhalable Drugs Market: Focus on INTAL and Market Dynamics

Introduction to Inhalable Drugs

The inhalable drugs market has been experiencing significant growth, driven by the increasing prevalence of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. This market includes various types of inhalable drugs, including those like INTAL, which is used to treat respiratory conditions.

Overview of INTAL

INTAL, also known as cromolyn sodium, is an anti-inflammatory medication used to prevent asthma attacks and other allergic reactions. It works by stabilizing mast cells, which are involved in the allergic response, thereby preventing the release of histamine and other mediators that cause allergic symptoms.

Market Size and Growth

The global inhalable drugs market was valued at USD 32.4 billion in 2023 and is expected to reach USD 60.8 billion by 2033, growing at a compound annual growth rate (CAGR) of 6.5% during the forecast period[1][4].

Product Type Segmentation

The market is segmented by product type, including aerosol, dry powder formulation, spray, and other types. Dry powder formulations, which include drugs like INTAL, held a significant market share of 38.4% in 2023[1].

Indication Segmentation

The market is also segmented by indication, with respiratory diseases accounting for the largest share of 62.1% in 2023. INTAL falls under this category, as it is primarily used to treat respiratory conditions such as asthma[1].

Distribution Channel Segmentation

Hospital pharmacies dominate the distribution channel segment, holding the largest revenue share of 45.2% in the inhalable drugs market. This indicates that a significant portion of inhalable drugs, including INTAL, are prescribed and dispensed through hospital settings[1].

Regional Analysis

North America leads the inhalable drugs market with a market share of 48% in 2023, driven by advanced healthcare infrastructure, high prevalence of respiratory diseases, and robust regulatory environments. The Asia Pacific region is expected to experience the highest CAGR during the forecast period due to rapid urbanization, increasing healthcare expenditure, and rising awareness about respiratory health issues[1].

Macroeconomic and Geopolitical Factors

Macroeconomic factors such as GDP growth rates, inflation, and healthcare expenditure significantly influence the inhalable drugs market. Economic downturns can constrain healthcare spending, while robust economic growth can drive demand for these drugs. Geopolitical factors like trade tensions and regulatory changes can also impact the market by disrupting supply chains and increasing manufacturing costs[1].

Financial Trajectory of Inhalable Drugs

The financial performance of the inhalable drugs market is closely tied to the prevalence of respiratory diseases and the efficiency of treatment alternatives. Here are some key financial highlights:

• Revenue Growth: The market is expected to grow from USD 32.4 billion in 2023 to USD 60.8 billion by 2033, indicating a strong financial trajectory[1].
• CAGR: A CAGR of 6.5% during the forecast period reflects steady and consistent growth driven by increasing demand for inhalable drugs[1].
• Distribution Channels: Hospital pharmacies, being the dominant distribution channel, play a crucial role in the financial performance of inhalable drugs like INTAL[1].

Impact of INTAL on the Market

INTAL, as a part of the dry powder formulation segment, contributes to the overall growth of the inhalable drugs market. Here are some key points:

• Usage: INTAL is widely used for preventing asthma attacks and other allergic reactions, contributing to the market share of dry powder formulations[1].
• Prescription Trends: The increasing prescription of INTAL and similar drugs reflects the growing need for effective and convenient treatment options for respiratory diseases[4].

Competitive Landscape

The inhalable drugs market is competitive, with several major pharmaceutical companies involved. Companies like AstraZeneca Plc., Vectura Group Ltd, GSK plc., and Boehringer Ingelheim International GmbH are key players in this market. These companies invest heavily in research and development to sustain their market position and innovate in drug formulations and delivery systems[1].

Innovations and Trends

The market is driven by several trends and innovations:

• Advancements in Drug Formulations: Continuous innovation in drug formulations, such as the development of more efficient inhalers, is a key trend. For instance, investments in the development of inhaled antibiotics and other inhalable drugs are gaining popularity[3].
• Patient-Centric Approach: There is an increasing focus on personalized medicine and patient-centric approaches, which are expected to drive the market forward[3].
• Targeted Therapies: The shift towards targeted therapies, especially in respiratory health, is another significant trend in the inhalable drugs market[3].

Challenges and Opportunities

Despite the growth, the market faces several challenges and opportunities:

• Antibiotic Resistance: The concern over antibiotic resistance is driving research into new and more effective inhalable antibiotics, presenting opportunities for innovation[3].
• Regulatory Environment: Robust regulatory environments, particularly in regions like North America, support the development and adoption of new inhalable drugs. However, regulatory uncertainties can also pose challenges[1].

Key Takeaways

• The inhalable drugs market is expected to grow significantly, driven by the increasing prevalence of respiratory diseases.
• INTAL, as part of the dry powder formulation segment, contributes to this growth.
• The market is influenced by macroeconomic and geopolitical factors.
• Innovations in drug formulations and delivery systems are key trends.
• The competitive landscape is dominated by major pharmaceutical companies.

FAQs

Q: What is the current market size of the inhalable drugs market? A: The global inhalable drugs market was valued at USD 32.4 billion in 2023[1].

Q: What is the expected CAGR of the inhalable drugs market from 2024 to 2033? A: The market is expected to grow at a CAGR of 6.5% during the forecast period[1].

Q: Which region dominates the inhalable drugs market? A: North America leads the market with a market share of 48% in 2023[1].

Q: What is the primary indication for INTAL? A: INTAL is primarily used to prevent asthma attacks and other allergic reactions, falling under the respiratory diseases category[1].

Q: What are the major trends in the inhalable drugs market? A: Key trends include innovations in drug formulations, a patient-centric approach, increased research in respiratory health, and advancements in drug delivery systems[3].

Sources

1. Market.us: Inhalable Drugs Market Size, Share, Growth | CAGR of 6.5% [2023]
2. Intra-Cellular Therapies: Intra-Cellular Therapies Reports Second Quarter 2024 Financial Results
3. The Business Research Company: Global Inhaled Antibiotics Market Report 2024
4. Grand View Research: Inhalable Drugs Market Size, Share & Growth Report, 2030