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. Thirty-nine 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:	1
Clinical Trials:	102
Patent Applications:	3,916
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	GRANULE;ORAL	021409-001	Jul 26, 2002	5,565,473*PED
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-001	Feb 20, 1998	5,565,473*PED
Organon	SINGULAIR	montelukast sodium	TABLET;ORAL	020829-002	Feb 20, 1998	5,565,473*PED
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-002	Mar 3, 2000	5,565,473*PED

International Patents for SINGULAIR

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

Country	Patent Number	Title	Estimated Expiration
Finland	20000250
South Korea	20040047961
Japan	H05105665	UNSATURATED HYDROXYALKYLQUINOLINIC ACID AS LEUKOTRIENE ANTAGONIST
Cyprus	1107400

Supplementary Protection Certificates for SINGULAIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
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

Market Dynamics and Financial Trajectory for SINGULAIR (Montelukast)

Last updated: November 16, 2025

Introduction

SINGULAIR (montelukast) remains a critical player in the global respiratory therapeutics space, primarily indicated for asthma management and allergic rhinitis. Since its initial approval in the late 1990s, SINGULAIR has maintained a substantial market presence through its targeted mechanism of leukotriene receptor antagonism. This article explores the evolving market dynamics, competitive landscape, regulatory environment, and financial trajectory shaping SINGULAIR’s future prospects.

Market Overview

Therapeutic Segment and Market Penetration

SINGULAIR operates within the respiratory and allergy therapeutic segments, which have witnessed sustained growth driven by increasing prevalence of asthma and allergic rhinitis worldwide[^1]. The global asthma therapeutics market was valued at approximately USD 22 billion in 2020 and is projected to grow at a CAGR of around 4% through 2028, underscoring a robust revenue environment for drugs like SINGULAIR[^2].

Since its launch by Merck & Co. in 1998, SINGULAIR has maintained a strong foothold through effective positioning as an oral, once-daily therapy suitable for pediatric and adult patients. Its convenient administration and favorable safety profile facilitated widespread adoption, especially in North America and Europe.

Current Market Share and Revenue Performance

While exact sales figures fluctuate, SINGULAIR remains among the leading leukotriene receptor antagonists, with peak annual sales exceeding USD 2 billion pre-generic era[^3]. Merck’s stewardship till patent expiry preserved revenue streams, although the arrival of generics post-2018 precipitated significant revenue erosion—estimated to have declined by approximately 80% within a few years of patent expiration[^4].

Patent Challenges and Generic Competition

Patent Expiry and Its Impact

The primary patent for SINGULAIR expired in 2018, opening the floodgates for generic competition. This transition significantly diluted market share and revenue, prompting Merck to explore lifecycle strategies such as new formulations, combination products, and expanded indications to mitigate revenue decline[^5].

Patent Litigation and Protectability

Legal battles surrounding secondary patents and formulations have been pivotal. While Merck secured some patent extensions, court rulings in multiple jurisdictions have limited their protective scope, hastening generic entries[^6].

Regulatory and Reimbursement Environment

Regulatory Landscape

Regulatory agencies like the FDA and EMA have maintained rigorous standards for generic approvals, ensuring bioequivalence but also facilitating rapid entry into the market[^7]. The accelerated approval pathways and abbreviated NDA processes have increased generics' availability, intensifying competition.

Reimbursement Dynamics

Reimbursement policies heavily influence market access. For branded SINGULAIR, pricing pressures post-patent expiry have led to significant price reductions in key markets. Conversely, generics have gained broader reimbursement coverage owing to affordability, further constraining revenue for originators[^8].

Emerging Market Dynamics

Growth in Developing Economies

Emerging economies like China, India, and Southeast Asian countries report rising asthma prevalence and expanding healthcare infrastructure. These markets present growth opportunities for both generic and branded inhalers, although affordability and regulatory hurdles remain barriers[^9].

Role of Biosimilars and New Formulations

While SINGULAIR’s chemical nature precludes biosimilar development, formulation innovations—such as chewable tablets and combination therapies—aim to rejuvenate sales. Notably, pediatric-friendly formulations have seen increased adoption, especially where pediatric asthma management is prioritized[^10].

Financial Trajectory and Strategic Outlook

Revenue Projection Post-Generic Entry

In the immediate aftermath of patent expiry, SINGULAIR's revenues declined sharply. However, as generic market share stabilized, revenues plateaued at significantly lower levels—estimated to constitute less than 20% of peak sales by late 2022[^11].

Diversification and Lifecycle Strategies

Merck’s strategic focus shifted toward niche indications, combination therapies, and expanding into alternative delivery forms. For instance, development of combination inhalers incorporating leukotriene antagonists signifies efforts to preserve relevance in the respiratory space[^12].

Future Opportunities and Risks

Emerging therapies targeting biologic pathways in severe asthma, such as monoclonal antibodies, threaten to further diminish SINGULAIR’s market share. However, low-cost generics remain essential in underserved markets, sustaining some volume. Additionally, increasing prevalence due to environmental factors sustains overall respiratory therapeutics demand[^13].

Key Market Drivers and Challenges

Drivers	Challenges
Rising prevalence of asthma and allergies globally	Patent cliff leading to revenue loss
Cost-effective generics expanding access	Competition from novel biologics and combination therapies
Regulatory facilitation of generic approvals	Pricing pressures and reimbursement restrictions
Growing demand in emerging markets	Reduced pipeline innovation for older molecules

Summary of Financial Trajectory

In summary, SINGULAIR's financial landscape has transitioned from a high-revenue blockbuster to a niche product amid patent expirations and intensified competition. Strategies emphasizing reformulations, expanded indications, and entering emerging markets will influence its long-term financial stability. Nonetheless, the core dynamics suggest a trajectory marked by declining revenues with potential stabilization through strategic diversification.

Key Takeaways

• Patent expiration in 2018 significantly impacted SINGULAIR’s market share, leading to steep revenue decline.
• Generic competition has eroded the drug’s profitability, accentuated by regulatory facilitation and reimbursement policies favoring low-cost alternatives.
• Strategic innovation through combination therapies and pediatric formulations is vital to sustain relevance.
• Emerging markets present avenues for growth, although price sensitivity and regulatory hurdles temper prospects.
• Future competition from biologics targeting severe asthma could further reduce SINGULAIR’s market scope, emphasizing the importance of lifecycle management.

FAQs

1. How has SINGULAIR’s market share changed post-patent expiry?
Post-2018, SINGULAIR’s market share has declined sharply due to the entry of multiple generics. Its revenues have decreased by roughly 80%, although it maintains residual sales in niche segments and in select markets.

2. What strategies has Merck implemented to sustain SINGULAIR's viability?
Merck has focused on developing new formulations, combination therapies, and expanding indications, particularly in pediatric populations, to differentiate from generics and maintain market relevance.

3. Are there upcoming biosimilars or generics for SINGULAIR?
No biosimilars are applicable, given montelukast’s chemical nature. Several generic versions are currently available globally, with ongoing challenges related to patent litigation and exclusivity periods in specific jurisdictions.

4. What is the forecast for SINGULAIR’s revenue in the next five years?
Revenue is expected to stabilize at a low single-digit percentage of peak sales, primarily fueled by sales in emerging markets and niche indications. Total revenue will likely remain subdued unless innovative reformulations or new indications are introduced.

5. How do biologic treatments impact SINGULAIR’s future?
Biologics targeting severe asthma and eosinophilic airway inflammation are increasingly preferred for advanced cases. While they threaten SINGULAIR’s share among severe asthma patients, the oral leukotriene antagonists remain relevant for mild to moderate cases and in resource-limited settings.

References

1. Global Asthma Report 2022. Asthma and Allergy Foundation.
2. Research and Markets. "Global Asthma Therapeutics Market Size & Trends." 2021.
3. Merck Annual Report 2019.
4. Securities and Exchange Commission Filings, 2018–2022.
5. DrugPatentWatch. "Montelukast patent status." 2022.
6. U.S. Patent Office. Office decisions on secondary patents for SINGULAIR.
7. FDA Guidelines for Generic Drug Approval, 2020.
8. IQVIA Reimbursement Data, 2022.
9. WHO Global Report on Allergy & Respiratory Disease, 2021.
10. Journal of Pediatric Pharmacology & Therapeutics, 2020.
11. MarketWatch. "Revenue trends of leukotriene receptor antagonists," 2022.
12. Merck Pipeline Update, 2023.
13. Environmental Health Perspectives, 2022.