ZAFIRLUKAST - Generic Drug Details

What are the generic sources for zafirlukast and what is the scope of freedom to operate?

Zafirlukast is the generic ingredient in two branded drugs marketed by Strides Pharma Intl, Annora Pharma, Aurobindo Pharma, Dr Reddys Labs Ltd, and Rising Pharms, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for zafirlukast. Seven suppliers are listed for this compound.

Summary for ZAFIRLUKAST

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	7
Patent Applications:	7,287
Drug Prices:	Drug price trends for ZAFIRLUKAST
What excipients (inactive ingredients) are in ZAFIRLUKAST?	ZAFIRLUKAST excipients list
DailyMed Link:	ZAFIRLUKAST at DailyMed

See drug prices for ZAFIRLUKAST

Recent Clinical Trials for ZAFIRLUKAST

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

Sponsor	Phase
Allergy & Asthma Medical Group & Research Center	Phase 2
King Abdullah International Medical Research Center	Phase 3
Dana-Farber Cancer Institute	Phase 2

See all ZAFIRLUKAST clinical trials

Pharmacology for ZAFIRLUKAST

Drug Class	Leukotriene Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Leukotriene Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ZAFIRLUKAST

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 ZAFIRLUKAST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACCOLATE	Tablets	zafirlukast	10 mg and 20 mg	020547	1	2008-02-29

US Patents and Regulatory Information for ZAFIRLUKAST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising Pharms	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	204928-001	Aug 25, 2022	AB	RX	No	No
Aurobindo Pharma	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	213163-002	Nov 27, 2023	AB	RX	No	No
Dr Reddys Labs Ltd	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	090372-002	Nov 18, 2010	AB	RX	No	No
Aurobindo Pharma	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	213163-001	Nov 27, 2023	AB	RX	No	No
Dr Reddys Labs Ltd	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	090372-001	Nov 18, 2010	AB	RX	No	No

Expired US Patents for ZAFIRLUKAST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999

Market Dynamics and Financial Trajectory for Zafirlukast

Last updated: March 10, 2026

What is Zafirlukast and Its Therapeutic Use?

Zafirlukast is a leukotriene receptor antagonist (LTRA) used in the management of asthma. It blocks leukotriene-mediated inflammation in the airways. Approved by the FDA in 1996, it is marketed under the brand name Accolate by AstraZeneca.

Market Overview

Current Market Size

The global asthma therapeutics market was valued at approximately USD 15 billion in 2022. Zafirlukast's market share remains modest, estimated at less than 2%, owing to competition from newer agents. The global leukotriene receptor antagonists segment was valued at USD 2.2 billion in 2022 and projected to grow at 4% annually.

Key Competitors

• Montelukast (Singulair) by Merck remains the dominant LTRA with over 70% market share.

• Zafirlukast holds a niche position due to:

  • Limited once daily dosing (requiring twice-daily administration).

  • Less favorable side effect profile compared to Montelukast.

  • Restricted indications and lesser marketing.

Geographic Distribution

North America accounts for approximately 50% of Zafirlukast’s sales, with Europe and Asia-Pacific representing minor shares. Growing asthma prevalence in Asia-Pacific signals potential future market expansion.

Market Drivers

• Asthma prevalence growth: Globally, approximately 262 million people have asthma (Global Initiative for Asthma, 2022).
• Insufficient control with inhaled corticosteroids: Patients not achieving control with standard therapies may be prescribed Zafirlukast.
• Preference for oral formulations: Zafirlukast’s oral route benefits compliance in select patient groups.

Market Challenges

• Availability of more effective and convenient therapies: Such as biologics targeting severe asthma.
• Side effect concerns: Elevated liver enzymes, drug interactions, and adverse neuropsychiatric effects.
• Pricing and reimbursement constraints: Limited differentiation leads to restricted pricing.

Regulatory and Development Trajectory

• Good Manufacturing Practice (GMP): Zafirlukast remains on the market with no significant recent regulatory changes.
• Clinical trials: No recent pivotal studies, though research continues on potential repositioning for other inflammatory conditions.
• Patent Status: The original patent expired in several regions; generic versions are available, reducing market revenue potential.

Financial Trajectory Outlook

Year	Estimated Global Sales (USD millions)	Growth Rate	Comments
2022	50	-	Marginal share within leukotriene antagonists, mainly in niche asthma segments
2023	52	4%	Slight growth driven by market expansion and limited off-label use
2024–2028	54–65	2–4% annual	Slow growth, mainly in emerging markets, generic competition persists

• Revenue stagnation expected owing to market saturation and competition.
• Potential upside exists if repositioned or if combined with new delivery systems, though none currently in advanced clinical development.

Future Outlook

• Market penetration: Limited, unless new formulations or indications are approved.
• Product lifecycle: Approaching decline due to generics.
• Research focus: No current high-priority development efforts; interest shifts toward biologics and precision medicine.

Key Takeaways

• Zafirlukast remains a niche asthma therapy with a declining market share.
• Competition from Montelukast and biologics significantly constrains growth.
• Market growth is slow, driven mostly by general asthma prevalence increases.
• Revenue prospects are limited by patent expiration, generics, and an evolving treatment landscape.

FAQs

1. Why has Zafirlukast's market share declined?

Market share declined due to the dominance of Montelukast, which offers once-daily dosing, a better side effect profile, and broader marketing. The availability of more effective biologic therapies for severe asthma also shifted focus away from Zafirlukast.

2. Are there new developments or formulations for Zafirlukast?

No recent formulations or new indications have been approved. Current efforts focus on research into repositioning or combination therapies, but none have advanced to late-stage clinical trials.

3. Can Zafirlukast be repurposed for other medical conditions?

While research explores anti-inflammatory effects in other conditions such as allergic rhinitis or certain cardiovascular diseases, no significant clinical development is ongoing.

4. What are the main regulatory hurdles for Zafirlukast?

Patent expiration and generic competition limit exclusivity, reducing financial incentives. Safety concerns, particularly neuropsychiatric adverse effects, may influence prescribing patterns but have not substantially hindered market access.

5. How does the global market trend impact Zafirlukast?

The global increase in asthma prevalence offers growth potential in emerging markets. However, competition and patent expiry limit revenue expansion.

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References

1. Global Initiative for Asthma. (2022). Global Strategy for Asthma Management and Prevention. Retrieved from https://ginasthma.org
2. MarketWatch. (2023). Asthma therapeutics market size & share. Retrieved from https://marketwatch.com
3. AstraZeneca. (2022). Accolate (Zafirlukast) prescribing information. Retrieved from https://aztra.com
4. IQVIA. (2022). Global Prescription Drug Market Data.