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Last Updated: December 22, 2024

ZAFIRLUKAST Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Zafirlukast

A generic version of ZAFIRLUKAST was approved as zafirlukast by DR REDDYS LABS LTD on November 18th, 2010.

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Summary for ZAFIRLUKAST
Drug patent expirations by year for ZAFIRLUKAST
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Recent Clinical Trials for ZAFIRLUKAST

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SponsorPhase
Allergy & Asthma Medical Group & Research CenterPhase 2
King Abdullah International Medical Research CenterPhase 3
National Institutes of Health (NIH)Phase 2

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Pharmacology for ZAFIRLUKAST
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 212475-001 Sep 10, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising Pharms ZAFIRLUKAST zafirlukast TABLET;ORAL 204928-001 Aug 25, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma ZAFIRLUKAST zafirlukast TABLET;ORAL 213163-002 Nov 27, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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].

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