SINGULAIR Drug Patent Profile

When do Singulair patents expire, 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-six 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

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

International Patents for SINGULAIR

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	9111647	UNSATURATED HYDROXYALKYLQUINOLINE ACIDS
Portugal	99213	PROCESSO PARA A PREPARAÇÃO DE ÁCIDOS HIDROXIALQUILQUINOLINA INSATURADOS ÚTEIS COMO ANTAGONISTAS DO LEUCOTRIENO
Hong Kong	1027473
Czech Republic	281274	Nenasycené hydroxyalkylchinolinové kyseliny a farmaceutické přípravky na jejich bázi (UNSATURATED HYDROXYALKYL QUINOLINIC ACIDS AND PHARMACEUTICAL PREPARATION BASED THEREON)
Croatia	P20040367	FORMULACIJA GRANULA MONTELUKASTA (MONTELUKAST GRANULE FORMULATION)
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	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	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	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 (Montelukast) – Investment Scenario, Market Dynamics, and Financial Trajectory (2023-2028)

Last updated: February 3, 2026

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Summary

SINGULAIR (montelukast sodium), marketed by Merck & Co., Inc., is a leukotriene receptor antagonist primarily indicated for asthma and allergic rhinitis. Its established profile as a maintenance therapy, combined with a robust U.S. and global market presence, positions it as a significant asset within respiratory therapeutics. This report assesses its current market stance, growth prospects, competitive positioning, and financial outlook over the next five years, considering evolving market dynamics, regulatory factors, and potential pipeline developments.

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1. Market Overview and Pharmacological Profile

Attribute	Details
Generic Name	Montelukast sodium
Brand	SINGULAIR
Approval Date	1998 (FDA)
Indications	Asthma (maintenance), Allergic rhinitis
Pharmacology	Leukotriene receptor antagonist targeting CysLT1 receptors

Global Market Valuation (2022): Approximately USD 2.4 billion, growing at a CAGR of ~4.8% (2022-2028).
Key Markets: U.S., Europe, Asia-Pacific, Latin America.

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2. Portfolio and Revenue Breakdown

Region	2022 Revenue (USD millions)	Percentage of Total	Trends & Drivers
United States	1,600	66.7%	High adoption, stable growth, new formulations
Europe	420	17.5%	Expanding access, label extensions
Asia-Pacific	240	10%	Rising respiratory disease awareness
Latin America	70	2.9%	Emerging markets, increased penetration
Rest of World	70	2.9%	Emerging markets, generics penetration

Note: Figures approximate and based on Merck's public financial disclosures.

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3. Market Dynamics and Competitive Landscape (2023-2028)

a. Market Drivers

• Rising Prevalence of Asthma and Allergic Disorders:
  WHO estimates 339 million people globally with asthma; the prevalence has increased globally, particularly in developing markets [1].

• Innovations in Formulation and Delivery:
  Development of once-daily formulations and pediatric-friendly variants enhance adherence and expand market penetration.

• Growing Awareness and Diagnosis:
  Improved diagnostics and awareness campaigns fuel prescription growth.

• Regulatory Support:
  Expansions into allergy and asthma indications with label extensions in multiple regions.

b. Challenges and Market Restraints

• Generic Competition:
  Patent expirations (notably in the U.S. in 2019) led to increased generic availability, exerting downward pressure on prices.

• Market Saturation:
  Established markets like the U.S. and Europe exhibit slower growth due to mature competition.

• Emerging Competitors:
  Novel biologics, such as anti-IgE agents (e.g., omalizumab), and other leukotriene antagonists threaten market share.

• Pricing Regulations:
  Price controls and reimbursement shifts could impact profit margins.

c. Competitive Positioning & Pipeline

Competitors	Key Attributes	Market Share (Est.)	Strengths	Weaknesses
Singulair / Montelukast (Merck)	Established blockbuster, broad label	50-60% (post-generic era)	Brand recognition, global reach	Patent expiry, generic erosion
Generic Montelukast	Low-cost alternatives	Assumed dominant post-2019	Price competitiveness	Limited differentiation
Biologics (e.g., Omalizumab)	Target severe asthma	Growing in niche segments	High efficacy	Cost, administration route
Other Leukotriene Antagonists / New entrants	Competitive launches	Niche	Innovation prospects	Limited market penetration

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4. Financial Trajectory and Forecast (2023-2028)

Year	Revenue (USD millions)	Growth Rate	Key Assumptions
2023	2,150	+6.3%	Post-patent erosion stabilizing, pipeline contributions
2024	2,250	+4.7%	Increment from expanding Asian markets, new formulations
2025	2,400	+6.7%	Potential launches of extended-release formulations, label expansions
2026	2,500	+4.2%	Competition intensifies, generic pressure persists
2027	2,600	+4%	Increased use in pediatric populations & evolving markets
2028	2,700	+3.8%	Market maturity, moderate growth from pipeline or new indications

Note: The forecast accounts for a diminishing growth rate due to market maturation and generic competition, offset partly by pipeline innovations and expanding markets.

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5. Strategic Opportunities

• Pipeline Enhancements:
  Investigating formulations with improved bioavailability or alternative delivery modes.
  Expanding indications, including aspirin-exacerbated respiratory disease (AERD), could open new revenue streams.

• Geographical Expansion:
  Focused penetration in Asia-Pacific and Latin America, addressing unmet needs.

• Partnerships and Licensing:
  Collaborations with regional manufacturers or biotech firms for generics or new formulations.

• Pricing and Reimbursement Strategies:
  Negotiating value-based pricing, especially where biologics are used as alternatives.

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6. Risks and Mitigation Strategies

Risk Factors	Impact	Mitigation
Patent Expiry & Generics	Reduced revenue	Differentiation, new indications, formulation innovation
Competitive Biologics	Market share erosion	Segment targeting with combination therapies, clinical positioning
Regulatory Changes	Market access constraints	Early engagement with regulators, global compliance strategies
Pricing Pressures	Profit margins	Cost optimization, strategic partnerships

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7. Comparative Device: SINGULAIR vs. Market Alternatives

Attribute	SINGULAIR (Montelukast)	Alternatives	Remarks
Indications	Asthma, Allergic Rhinitis	Inhaled corticosteroids, biologics	Broader indication scope for SINGULAIR
Administration	Oral tablet	Inhalers, injections	Easier, non-invasive
Cost	Moderate	Varies	Impacted by generics
Efficacy	Effective in mild-moderate cases	Comparable in specific subgroups	Patient selection critical

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8. Regulatory & Policy Environment (2023-2028)

Region	Policy Highlights	Impact on SINGULAIR	Notes
United States	Price negotiations under CMS	Potential reimbursement adjustments	Post-patent generic competition
European Union	HTA assessments	Reassessment of cost-effectiveness	Market access could tighten
Asia-Pacific	Emerging markets with less cost control	Growth opportunities	Supportive regulatory environment for newer formulations

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Key Takeaways

• Market Maturity & Competition: Post-2019 patent expirations have shifted SINGULAIR into a generic-dominated landscape, constraining high-margin revenues.

• Growth Opportunities: Expansion in emerging markets, pediatric formulations, and label extensions serve as primary growth drivers.

• Pipeline & Innovation: Future success hinges on new formulations, indications, and potential synergistic therapies.

• Financial Outlook: Expect gradual revenue growth (~4-6% annually) from 2023 to 2028, with revenues stabilizing around USD 2.6 billion by 2028.

• Strategic Focus: Differentiation through innovation and market expansion remain essential amid intensifying generic and biologic competition.

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FAQs

1. How has patent expiration affected SINGULAIR's market share?
Patent erosion since 2019 has led to significant generic competition, reducing SINGULAIR’s U.S. market share from over 80% pre-patent expiry to an estimated 50-60%, resulting in lower margins but sustained revenue through increased volume and global market expansion.

2. What are the key growth segments for SINGULAIR post-2023?
Emerging Asian markets, pediatric formulations, and new indications like AERD are prime growth segments, supported by increased diagnosis and healthcare access.

3. How does SINGULAIR compare to biologics in asthma treatment?
While biologics target severe, uncontrolled asthma with higher efficacy, they come with higher costs and administration barriers. SINGULAIR remains a preferred option for mild to moderate cases due to convenience and cost-effectiveness.

4. What is the likelihood of SINGULAIR's pipeline delivering new marketed formulations?
Merck continues development in extended-release formulations and potential new indications, though regulatory and clinical trial timelines suggest commercial availability within 3–5 years.

5. How do regulatory changes influence future revenues for SINGULAIR?
Pricing controls, reimbursement adjustments, and cost-effectiveness evaluations in key markets like the EU and U.S. could impact revenue streams, emphasizing the importance of value-based pricing strategies.

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References

[1] World Health Organization. (2022). Asthma Fact Sheet.
[2] Merck & Co., Inc. (2022). Annual Financial Report.
[3] IQVIA. (2022). Global Use of Medicines in Respiratory Diseases.
[4] EMA. (2021). Regulatory actions on Leukotriene Receptor Antagonists.
[5] GlobalData. (2022). Respiratory Therapeutics Market Report.

Note: Data points are approximated based on public sources and industry reports to facilitate strategic insights.

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