MONTELUKAST SODIUM - Generic Drug Details

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

Montelukast sodium is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Norvium Bioscience, Teva Pharms, Torrent, Organon, Amneal Pharms, Anbison Lab, Apotex Inc, Chartwell Molecular, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Natco Pharma, Rising, Sandoz Inc, Strides Pharma, Torrent Pharms Ltd, Unichem, Unimark Remedies Ltd, Accord Hlthcare, Apotex Corp, Breckenridge, Cipla, Glenmark Pharms Ltd, and L Perrigo Co, and is included in fifty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-three drug master file entries for montelukast sodium. Forty-one suppliers are listed for this compound.

Summary for MONTELUKAST SODIUM

US Patents:	0
Tradenames:	2
Applicants:	29
NDAs:	52
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	81
Patent Applications:	6,479
Drug Sales Revenues:	Drug sales revenues for MONTELUKAST SODIUM
What excipients (inactive ingredients) are in MONTELUKAST SODIUM?	MONTELUKAST SODIUM excipients list
DailyMed Link:	MONTELUKAST SODIUM at DailyMed

See drug sales revenues for MONTELUKAST SODIUM

Recent Clinical Trials for MONTELUKAST SODIUM

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

Sponsor	Phase
Mansoura University Children Hospital	Phase 1
The Children's Hospital of Zhejiang University School of Medicine	Phase 4
Zhejiang Provincial Hospital of TCM	Phase 4

See all MONTELUKAST SODIUM clinical trials

Pharmacology for MONTELUKAST SODIUM

Drug Class	Leukotriene Receptor Antagonist
Mechanism of Action	Leukotriene Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for MONTELUKAST SODIUM

R03DC	Leukotriene receptor antagonists
R03D	OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for MONTELUKAST SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SINGULAIR	Oral Granules	montelukast sodium	4 mg	021409	1	2008-10-17
SINGULAIR	Tablets	montelukast sodium	10 mg	020829	2	2007-02-20
SINGULAIR	Chewable Tablets	montelukast sodium	4 mg and 5 mg	020830	1	2006-12-26

US Patents and Regulatory Information for MONTELUKAST SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex Inc	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	201508-002	Aug 3, 2012		DISCN	No	No
Unichem	MONTELUKAST SODIUM	montelukast sodium	TABLET;ORAL	204290-001	Oct 8, 2015	AB	RX	No	No
Norvium Bioscience	MONTELUKAST SODIUM	montelukast sodium	TABLET;ORAL	079103-001	Aug 3, 2012		DISCN	No	No
Teva Pharms	MONTELUKAST SODIUM	montelukast sodium	TABLET;ORAL	078605-001	Aug 3, 2012	AB	RX	No	No
Apotex Inc	MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	201508-001	Aug 3, 2012		DISCN	No	No
Norvium Bioscience	MONTELUKAST SODIUM	montelukast sodium	GRANULE;ORAL	202776-001	Dec 18, 2012		DISCN	No	No

Expired US Patents for MONTELUKAST SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	SINGULAIR	montelukast sodium	TABLET;ORAL	020829-002	Feb 20, 1998
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-001	Feb 20, 1998
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-002	Mar 3, 2000
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002

MONTELUKAST SODIUM Market Analysis and Financial Projection Experimental

Montelukast Sodium Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The montelukast sodium market is poised for significant growth over the coming years. As of 2024, the market size is estimated to be around USD 4.08 billion, with a projected growth to USD 7.38 billion by 2029, at a Compound Annual Growth Rate (CAGR) of 12.60%[1].

Another forecast suggests that the market will grow from USD 0.451 billion in 2023 to USD 2.24 billion by 2034, with a CAGR of 15.71% during the forecast period of 2024-2034[2].

Regional Market Performance

• North America: This region currently holds the largest market share in the montelukast sodium market, driven by the high prevalence of respiratory conditions such as asthma and allergic rhinitis, and the presence of well-developed healthcare infrastructure[3][4].
• Asia Pacific: This region is expected to be the fastest-growing market during the forecast period, driven by a growing geriatric population, increasing healthcare expenditure, and the high incidence of respiratory diseases due to environmental pollution[1][3][4].

Key Drivers of Market Growth

• Rising Prevalence of Respiratory Diseases: The increasing incidence of asthma, allergic rhinitis, and other respiratory disorders globally is a significant driver of the montelukast sodium market. As air pollution levels rise and lifestyles change, the demand for effective medications like montelukast sodium is escalating[2][3][4].
• Aging Population: The growing geriatric population is more susceptible to respiratory illnesses, leading to an increased demand for montelukast sodium[2][3][4].
• Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in emerging economies, are making montelukast sodium more accessible and contributing to market growth[3][4].
• Research and Development: Continuous investments in R&D are leading to innovative formulations and delivery methods, enhancing the efficacy and patient compliance of montelukast sodium[3][4].

Product Type and Dosage Form

• Amorphous vs. Crystalline Forms: The amorphous form of montelukast sodium accounted for the highest revenue in 2023 due to its superior bioavailability and solubility. However, the crystalline segment is expected to grow at the fastest CAGR during the forecast period due to its long-term stability and scalability[2].
• Tablets and Oral Solutions: Tablets are the highest revenue-grossing segment by dosage form, thanks to their convenience and widespread patient acceptance. Oral solutions, however, are expected to grow at the fastest CAGR due to the rising demand for alternative dosage forms and patient-centric drug delivery[2][4].

Applications of Montelukast Sodium

• Asthma: This segment accounts for the highest revenue due to the global prevalence of asthma and the effectiveness of montelukast sodium in managing asthma symptoms[2][3][4].
• Allergic Rhinitis: Montelukast sodium is also widely used to relieve symptoms of allergic rhinitis, such as itching, sneezing, and nasal congestion[2][3].

Market Concentration and Key Players

The montelukast sodium market has a medium level of concentration. Key players include Merck & Co., Inc., Morepen Laboratories, Teva Pharmaceuticals USA, Inc., Cipla Limited, Sanofi Aventis, Sandoz International, and Sun Pharmaceutical Industries[1][3][4].

Challenges and Opportunities

• Complexities in Screening and Diagnosis: Despite the growth, the market faces challenges related to the complexities in screening and diagnosis of respiratory diseases, which can hinder timely intervention and treatment[5].
• Patient Assistance Initiatives: Government and advocacy group initiatives to assist patients are contributing to the market's expansion by making montelukast sodium more accessible[5].

Financial Trajectory

The financial trajectory of the montelukast sodium market is robust, with multiple forecasts indicating significant growth:

• 2023-2029: Expected to grow from USD 3.62 billion in 2023 to USD 7.38 billion by 2029 at a CAGR of 12.60%[1].
• 2023-2034: Predicted to grow from USD 0.451 billion in 2023 to USD 2.24 billion by 2034 at a CAGR of 15.71%[2].
• 2023-2032: Anticipated to grow from USD 293.80 million in 2023 to USD 773.78 million by 2032 at a CAGR of 11.4%[3].

Key Takeaways

• The montelukast sodium market is driven by the rising prevalence of respiratory diseases, an aging population, and advancements in healthcare infrastructure.
• North America is the largest market, while Asia Pacific is expected to be the fastest-growing region.
• Innovative formulations and patient-centric drug delivery methods are enhancing market growth.
• Key players are focusing on R&D and strategic partnerships to expand their market share.

FAQs

1. What is the current market size of the montelukast sodium market? The current market size of the montelukast sodium market is estimated to be around USD 4.08 billion in 2024[1].

2. Which region is expected to grow the fastest in the montelukast sodium market? The Asia Pacific region is expected to grow the fastest during the forecast period due to its growing geriatric population and high incidence of respiratory diseases[1][3][4].

3. What are the primary applications of montelukast sodium? Montelukast sodium is primarily used in the treatment of asthma and allergic rhinitis[2][3][4].

4. Who are the key players in the montelukast sodium market? Key players include Merck & Co., Inc., Morepen Laboratories, Teva Pharmaceuticals USA, Inc., Cipla Limited, Sanofi Aventis, Sandoz International, and Sun Pharmaceutical Industries[1][3][4].

5. What are the major drivers of the montelukast sodium market growth? The major drivers include the rising prevalence of respiratory diseases, an aging population, advancements in healthcare infrastructure, and continuous investments in R&D[2][3][4].

Cited Sources

1. Mordor Intelligence: Montelukast Sodium Market Size & Share Analysis - Growth Trends[1]
2. GlobeNewswire: Global Montelukast Sodium Market Report 2024: A USD 2.24 Billion Market by 2034 at a CAGR of 15.7[2]
3. Polaris Market Research: Montelukast Sodium Market Share and Size, Future Growth 2024[3]
4. The Business Research Company: Montelukast Sodium Global Market Report 2024[4]
5. Technavio: Montelukast Sodium Market Size 2024-2028[5]