SINGULAIR Drug Patent Profile

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

Singulair is a drug marketed by Organon and is included in three NDAs.

The generic ingredient in SINGULAIR is montelukast sodium. There are thirty-five drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Singulair

A generic version of SINGULAIR was approved as montelukast sodium by AUROBINDO PHARMA LTD on August 3^rd, 2012.

Summary for SINGULAIR

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	102
Patent Applications:	4,129
Drug Prices:	Drug price information for SINGULAIR
What excipients (inactive ingredients) are in SINGULAIR?	SINGULAIR excipients list
DailyMed Link:	SINGULAIR at DailyMed

See drug prices for SINGULAIR

See drug sales revenues for SINGULAIR

Recent Clinical Trials for SINGULAIR

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

Sponsor	Phase
Michael E. DeBakey VA Medical Center	Phase 1
Baylor College of Medicine	Phase 1
Texas A&M University	Phase 1

See all SINGULAIR clinical trials

Pharmacology for SINGULAIR

Drug Class	Leukotriene Receptor Antagonist
Mechanism of Action	Leukotriene Receptor Antagonists

Paragraph IV (Patent) Challenges for SINGULAIR

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 SINGULAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002	AB	RX	Yes	Yes
Organon	SINGULAIR	montelukast sodium	TABLET;ORAL	020829-002	Feb 20, 1998	AB	RX	Yes	Yes
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-002	Mar 3, 2000	AB	RX	Yes	No
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-001	Feb 20, 1998	AB	RX	Yes	Yes

Expired US Patents for SINGULAIR

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

International Patents for SINGULAIR

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0480717
Portugal	1441701
Canada	2463947	FORMULATION DE GRANULES DE MONTELUKAST (MONTELUKAST GRANULE FORMULATION)
Cyprus	1107400
Brazil	1100383
Finland	914796
Germany	69129257

Supplementary Protection Certificates for SINGULAIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0480717	98C0022	France		PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0480717	C990009	Netherlands		PRODUCT NAME: MONTELUKASTUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NATRII MONTELUKASTUM; NATL REGISTRATION NO/DATE: RVG 23164 AND RVG 23165 19981103; FIRST REGISTRATION: FI 12766 AND 12767 19970825
0480717	9890027-7	Sweden		PRODUCT NAME: MONTELUKAST, R-(E)-1-1-3-2-(7-KLOR-2KINOLINYL)-ETENYL)-FENYL)-3-(2-(1-HYDROXI-1-METYLETYL)-FENYL)-PROPYL)-TIO)METYL)-CYKLOPROPANAETTIKSYRA, ELLER ETT FARMACEUTISKT GODDTAGBART SALT DAERAV, FOERETRAEDESVIS NATRIUMSALTET; NAT REG./DATE: 13944 19880111; FIRST REG.: FI EG 12766 19970825
0480717	19/1999	Austria		PRODUCT NAME: MONTELUKAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MONTELUKASTNATRIUM; NAT. REGISTRATION NO/DATE: 1-22765 UND 1-22766 19981030; FIRST REGISTRATION: FI 12766 UND 12767 19970825
0480717	SPC/GB98/025	United Kingdom		PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115

SINGULAIR Market Analysis and Financial Projection Experimental

Montelukast Sodium Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction to Montelukast Sodium

Montelukast sodium, commonly known by the brand name Singulair, is a leukotriene inhibitor used to treat various respiratory and allergic conditions, including asthma, allergic rhinitis, and exercise-induced bronchospasm. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Market Size and Growth Projections

The montelukast sodium market is experiencing significant growth. As of 2023, the market size was estimated to be around $3.52 billion, and it is projected to grow to $3.86 billion in 2024 at a compound annual growth rate (CAGR) of 9.6%[3].

By 2027, the market is expected to reach $946 million, growing at a CAGR of 11.3% during the forecast period 2022-2027[1]. Moreover, by 2029, the market is anticipated to expand to $7.38 billion, with a CAGR of 12.60% from 2024 to 2029[4].

Market Segmentation

The montelukast sodium market is segmented based on several criteria:

By Product

• Crystal-like and form-less or amorphous forms are the primary product types[3].

By Dosage Form

• Tablets and oral solutions are the main dosage forms. The pills/tablets segment is expected to be the fastest-growing, driven by the geriatric population's preference and the high accuracy and low production costs of pills[1].

By Application

• The drug is used for various conditions including bronchospasm, allergic coryza, asthma, urticaria, and other applications. Asthma treatment is a significant segment, particularly for exercise-induced asthma and asthma associated with allergic rhinitis[3][4].

Geographical Analysis

North America

• This region held the largest share of the market in 2021, with approximately 33% of the overall market. The growth here is driven by increasing cases of breathing abnormalities, poor dietary habits, and a well-established healthcare infrastructure[1].

Asia-Pacific

• This region is expected to be the fastest-growing over the forecast period, driven by an expanding geriatric population, especially in countries like India and China, and worsening pollution problems[1][4].

Market Drivers

Growing Geriatric Population

• The increasing global population, particularly the elderly, is more prone to respiratory problems, thereby driving the demand for montelukast sodium. By 2030, the number of people aged 65 or older is expected to reach 994 million, and by 2050, it will be 1.6 billion[4].

Soaring Pollution Problem

• Rapid industrialization and increasing air pollution levels are contributing to rising respiratory disorders, which in turn boost the demand for montelukast sodium[1].

Increasing Respiratory Disorders

• The rise in respiratory conditions such as asthma, COPD, and pneumonia is a significant driver. For instance, approximately 25 million Americans have asthma, which translates to about 1 in every 13 people[1].

Market Trends

Generic Competition

• The market is expected to see increased generic competition, which could impact the pricing and market share of branded products like Singulair[3].

Shift Towards Combination Therapies

• There is a growing trend towards using montelukast in combination with other drugs, such as inhaled corticosteroids (ICS), which is enhancing its positioning in asthma treatment[4].

Expansion in Emerging Markets

• The growth in emerging markets, particularly in Asia-Pacific, is driven by increasing GDP and the ability to invest more in healthcare and research[1][4].

Focus on Pediatric Use

• Asthma is a common chronic condition in children, leading to increased demand for montelukast sodium. The CDC's National Asthma Control Program (NACP) and other initiatives are raising awareness and driving adoption[4].

Financial Performance and Projections

The financial performance of the montelukast sodium market is robust, with significant growth projections:

• By 2024, the market size is expected to reach $4.08 billion and grow to $7.38 billion by 2029[4].
• The CAGR for the period 2024-2029 is estimated at 12.60%, indicating strong growth potential[4].

Challenges and Restraints

Side Effects

• Side effects such as stomach pain, heartburn, upset stomach, nausea, and diarrhea may restrain market growth. However, the benefits of the drug in treating severe respiratory conditions often outweigh these side effects[4].

Key Players

Major players in the montelukast sodium market include:

• Merck & Co., Inc.
• Morepen Laboratories
• Teva Pharmaceuticals USA, Inc.
• Cipla Limited
• Sanofi Aventis[4].

Conclusion

The montelukast sodium market, driven by the increasing prevalence of respiratory disorders, an aging population, and rising pollution levels, is poised for significant growth. The market's segmentation by product, dosage form, and application, along with geographical trends, highlights the diverse and expanding demand for this medication.

Key Takeaways

• The montelukast sodium market is expected to grow significantly, reaching $7.38 billion by 2029.
• The Asia-Pacific region is the fastest-growing segment.
• The geriatric population and increasing pollution are key drivers.
• Generic competition and a shift towards combination therapies are major trends.
• Side effects may restrain market growth but are often outweighed by the drug's benefits.

Frequently Asked Questions (FAQs)

1. What is the current market size of the montelukast sodium market?

The montelukast sodium market size is expected to reach $4.08 billion in 2024[4].

2. Which region holds the largest share in the montelukast sodium market?

North America holds the largest share in the montelukast sodium market as of 2021[1].

3. What are the primary applications of montelukast sodium?

Montelukast sodium is primarily used for treating bronchospasm, allergic coryza, asthma, urticaria, and other respiratory conditions[3].

4. What are the major drivers of the montelukast sodium market?

The growing geriatric population, soaring pollution problem, and increasing respiratory disorders are major drivers of the market[1][4].

5. Who are the key players in the montelukast sodium market?

Key players include Merck & Co., Inc., Morepen Laboratories, Teva Pharmaceuticals USA, Inc., Cipla Limited, and Sanofi Aventis[4].

Cited Sources:

1. IndustryARC: Montelukast Sodium Market - Forecast(2024 - 2030)[1].
2. StockTitan: Singular Genomics Reports Recent Highlights and Second Quarter 2024 Financial Results[2].
3. The Business Research Company: Montelukast Sodium Global Market Report 2024[3].
4. Mordor Intelligence: Montelukast Sodium Market Size & Share Analysis - Growth Trends[4].