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, 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:	113
Clinical Trials:	7
Patent Applications:	6,862
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
National Institutes of Health (NIH)	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
Annora Pharma	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	212475-002	Sep 10, 2020	AB	RX	No	No
Aurobindo Pharma	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	213163-001	Nov 27, 2023	AB	RX	No	No
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	AB	RX	Yes	No
Dr Reddys Labs Ltd	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	090372-001	Nov 18, 2010	AB	RX	No	No
Rising Pharms	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	204928-001	Aug 25, 2022	AB	RX	No	No
Annora Pharma	ZAFIRLUKAST	zafirlukast	TABLET;ORAL	212475-001	Sep 10, 2020	AB	RX	No	No

Expired US Patents for ZAFIRLUKAST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	5,319,097
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	6,143,775
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	5,583,152
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	5,294,636
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	4,859,692
Strides Pharma	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	6,143,775

ZAFIRLUKAST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zafirlukast

Overview of Zafirlukast

Zafirlukast, marketed under the brand name Accolate, is an oral leukotriene receptor antagonist (LTRA) primarily used for the maintenance treatment of asthma. It works by blocking the action of cysteinyl leukotrienes on the CysLT1 receptors, thereby reducing airway constriction, mucus buildup, and inflammation[2][4][5].

Market Size and Growth

The U.S. asthma drugs market, which includes zafirlukast, is experiencing significant growth. As of 2023, the U.S. asthma drugs market was valued at USD 8.95 billion and is projected to surpass USD 14.75 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.12% from 2024 to 2033[3].

Globally, the asthma drugs market is also on an upward trend. In 2024, the global market size was estimated at USD 25.69 billion and is expected to reach around USD 40.17 billion by 2033, with a CAGR of 5.09% during the forecast period[3].

Market Drivers

Rising Prevalence of Asthma

A key driver of the market growth is the increasing prevalence of asthma. Approximately 25 million individuals in the United States suffer from asthma, contributing significantly to the demand for asthma medications like zafirlukast[3].

Therapeutic Superiority

Clinical studies have shown that zafirlukast, when used in conjunction with other treatments, can significantly reduce the risk of severe asthma attacks. For instance, treatment with Airsupra (another asthma medication) has demonstrated a 28% reduction in the risk of severe asthma attacks, highlighting the therapeutic superiority of such medications and driving market demand[3].

Off-Label Uses

Zafirlukast is also used off-label for managing chronic urticaria, preventing exercise-induced bronchospasm, and treating allergic conditions. These additional uses expand its market potential beyond just asthma treatment[4].

Market Segmentation

The U.S. asthma drugs market is segmented into pediatric, adult, and adolescent segments. The adult segment is the dominant force and is expected to maintain its market leadership throughout the forecast period. Zafirlukast, being commonly prescribed for chronic asthma in adults, benefits from this segmentation[3].

Competitive Landscape

The market for zafirlukast is competitive, with several key players involved in its production and distribution. These include Target Molecule Corp., Merck, Cayman Chemical Company, APExBIO Technology LLC, and many others. The presence of multiple manufacturers ensures a steady supply and competitive pricing, which can influence market dynamics[1].

Financial Performance

Revenue and Prescriptions

Zafirlukast continues to be a widely used drug, with over 2 million prescriptions dispensed annually in the United States. This high prescription volume contributes significantly to its revenue. The drug's approval by the FDA in 1996 has established it as a staple in asthma treatment, ensuring a stable financial trajectory[4].

Pricing and Accessibility

The pricing of zafirlukast can be influenced by its availability as a generic medication, which often reduces costs compared to brand-name drugs. However, the need for regular dosing and the potential for long-term use can still result in substantial revenue for manufacturers[5].

Challenges and Considerations

Side Effects and Contraindications

Zafirlukast is associated with side effects such as rash and upset stomach. Additionally, it is not recommended for patients with hepatic impairment due to compromised hepatic clearance, which can increase the maximum plasma concentration by 50-60%. These factors can impact its market performance and financial trajectory[2][4][5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of zafirlukast. FDA approvals and updates, such as the recent approvals of other asthma medications like TEZSPIRE, can influence market competition and the financial performance of zafirlukast[3].

Future Outlook

Given the rising prevalence of asthma and the therapeutic superiority of zafirlukast, the drug is expected to continue playing a significant role in the asthma treatment market. The global and U.S. market projections indicate a steady growth trajectory, suggesting that zafirlukast will remain a valuable asset for pharmaceutical companies involved in its production and distribution.

Key Takeaways

• Market Growth: The U.S. and global asthma drugs markets are expected to grow significantly, driven by the increasing prevalence of asthma.
• Therapeutic Superiority: Zafirlukast's effectiveness in reducing severe asthma attacks and its off-label uses enhance its market potential.
• Competitive Landscape: Multiple manufacturers are involved, ensuring a competitive market.
• Financial Performance: High prescription volumes and long-term use contribute to stable revenue.
• Challenges: Side effects and contraindications, particularly for patients with hepatic impairment, need careful management.

FAQs

Q: What is zafirlukast used for?

A: Zafirlukast is primarily used for the maintenance treatment of asthma and can also be used off-label for conditions like chronic urticaria and exercise-induced bronchospasm[2][4].

Q: How does zafirlukast work?

A: Zafirlukast works by blocking the action of cysteinyl leukotrienes on the CysLT1 receptors, reducing airway constriction, mucus buildup, and inflammation[2][4].

Q: What are the common side effects of zafirlukast?

A: Common side effects include rash and upset stomach. It is also important to monitor for signs of liver problems[2][4].

Q: Can zafirlukast be used in patients with hepatic impairment?

A: No, zafirlukast is not recommended for patients with hepatic impairment due to compromised hepatic clearance[4][5].

Q: How is zafirlukast typically administered?

A: Zafirlukast is usually taken as a tablet, twice daily, and should be taken on an empty stomach to maximize absorption[5].