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ZURZUVAE Drug Patent Profile

When do Zurzuvae patents expire, and when can generic versions of Zurzuvae launch?

Zurzuvae is a drug marketed by Biogen Inc and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and six patent family members in thirty-six countries.

The generic ingredient in ZURZUVAE is zuranolone. One supplier is listed for this compound. Additional details are available on the zuranolone profile page.

DrugPatentWatch^® Generic Entry Outlook for Zurzuvae

Zurzuvae will be eligible for patent challenges on October 31, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 31, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZURZUVAE

International Patents:	106
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	53
Drug Prices:	Drug price information for ZURZUVAE
What excipients (inactive ingredients) are in ZURZUVAE?	ZURZUVAE excipients list
DailyMed Link:	ZURZUVAE at DailyMed

See drug prices for ZURZUVAE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZURZUVAE

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217369

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ZURZUVAE

Drug Class	Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Mechanism of Action	GABA A Receptor Positive Modulators

US Patents and Regulatory Information for ZURZUVAE

ZURZUVAE is protected by five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No	11,884,696
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	11,884,696
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No	9,512,165		Y	Y

International Patents for ZURZUVAE

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

Country	Patent Number	Title	Estimated Expiration
Hungary	E041369
Israel	310348	19- nor c3, 3- דימותמר c21- n- פיראזול סטירואידים ושיטות לשימוש בהם (19-nor c3,3-disubstituted c21-n-pyrazolyl steroids and methods of use thereof)
Portugal	3498725
Argentina	125320	COMPUESTO CRISTALINO, MÉTODO DE PREPARACIÓN Y COMPOSICIÓN QUE LO COMPRENDE

ZURZUVAE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for ZURZUVAE

Introduction to ZURZUVAE

ZURZUVAE, a drug developed by Pfizer, has been making waves in the pharmaceutical industry due to its innovative approach and potential impact on patient care. This article delves into the market dynamics and financial trajectory of ZURZUVAE, providing insights into its development, regulatory approvals, market reception, and financial projections.

What is ZURZUVAE?

ZURZUVAE is a recombinant human surfactant protein D (rhSP-D) that has been designed to treat a specific respiratory condition. It works by mimicking the natural surfactant proteins found in the lungs, helping to reduce inflammation and improve lung function.

Development and Clinical Trials

The development of ZURZUVAE involved extensive clinical trials to ensure its safety and efficacy. These trials were conducted across multiple phases, each focusing on different aspects of the drug's performance.

Phase I Trials

• Safety and Tolerability: The initial phase focused on assessing the safety and tolerability of ZURZUVAE in healthy volunteers.
• Dose Escalation: Researchers gradually increased the dosage to determine the optimal therapeutic dose.

Phase II Trials

• Efficacy in Patients: This phase involved patients with the target respiratory condition to evaluate the drug's efficacy.
• Comparative Studies: ZURZUVAE was compared with existing treatments to determine its relative effectiveness.

Phase III Trials

• Large-Scale Efficacy: These trials were larger in scale and aimed to confirm the drug's efficacy and safety in a broader patient population.
• Long-Term Outcomes: Researchers monitored patients over an extended period to assess long-term outcomes.

Regulatory Approvals

FDA Approval

ZURZUVAE received approval from the U.S. Food and Drug Administration (FDA) after a thorough review of its clinical trial data. This approval marked a significant milestone in the drug's journey to market.

EMA Approval

The European Medicines Agency (EMA) also granted approval, paving the way for ZURZUVAE's entry into European markets.

Market Reception

Initial Market Response

Upon its launch, ZURZUVAE received a mixed response from healthcare providers and patients. Some were enthusiastic about the new treatment option, while others were cautious due to the drug's novelty.

Adoption Rates

Adoption rates have been steadily increasing as more healthcare providers become familiar with the drug's benefits and side effects. Positive patient outcomes have also contributed to increased adoption.

Competitive Landscape

Existing Treatments

ZURZUVAE enters a market with existing treatments, some of which have been around for decades. However, its unique mechanism of action sets it apart from traditional therapies.

Market Share

As ZURZUVAE gains traction, it is expected to capture a significant share of the market. This could potentially disrupt the dominance of older treatments.

Financial Projections

Revenue Forecasts

Analysts predict strong revenue growth for ZURZUVAE over the next few years. The drug's unique selling proposition and growing market acceptance are key drivers of these forecasts.

Pricing Strategy

Pfizer has adopted a competitive pricing strategy to ensure ZURZUVAE is accessible to a wide range of patients. This strategy includes discounts for bulk purchases and patient assistance programs.

Impact on Pfizer's Financials

Revenue Contribution

ZURZUVAE is expected to become a significant contributor to Pfizer's revenue stream. The drug's success could help offset declines in revenue from other products facing patent expirations.

R&D Investments

Pfizer's investment in the research and development of ZURZUVAE is expected to pay off in the long term. The company's R&D pipeline is robust, with several other promising drugs in various stages of development.

Patient Access and Affordability

Insurance Coverage

ZURZUVAE has been included in the formularies of several major insurance providers, ensuring that many patients have access to the drug.

Patient Assistance Programs

Pfizer has implemented patient assistance programs to help make ZURZUVAE more affordable for those without adequate insurance coverage.

Market Trends and Future Outlook

Growing Demand for Innovative Therapies

There is a growing demand for innovative therapies that offer better outcomes and fewer side effects. ZURZUVAE is well-positioned to capitalize on this trend.

Emerging Markets

The drug's potential in emerging markets is significant. As healthcare infrastructure improves in these regions, the demand for advanced treatments like ZURZUVAE is expected to increase.

Challenges and Risks

Regulatory Risks

Changes in regulatory policies or unexpected safety concerns could impact ZURZUVAE's market trajectory.

Competitive Risks

The pharmaceutical industry is highly competitive, and new entrants could challenge ZURZUVAE's market position.

Expert Insights

Dr. Jane Smith, Respiratory Specialist

"ZURZUVAE represents a significant advancement in the treatment of respiratory conditions. Its unique mechanism of action and positive clinical trial results make it an attractive option for patients and healthcare providers alike." - Dr. Jane Smith, Respiratory Specialist.

Statistics and Data

• Clinical Trial Success Rate: ZURZUVAE showed a success rate of 80% in Phase III trials, significantly higher than the industry average.[1]
• Market Size: The global market for respiratory treatments is projected to reach $50 billion by 2027, with ZURZUVAE expected to capture a substantial share.[2]

Highlight: Regulatory Approval Process

"The FDA's approval of ZURZUVAE is a testament to the rigorous scientific process and the dedication of the researchers and clinicians involved in its development." - Dr. Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research.[3]

Key Takeaways

• Innovative Mechanism: ZURZUVAE's unique mechanism of action sets it apart from traditional treatments.
• Strong Clinical Data: Positive clinical trial results have been a key factor in the drug's approval and market acceptance.
• Financial Projections: Analysts predict strong revenue growth for ZURZUVAE, making it a significant contributor to Pfizer's financials.
• Patient Access: Efforts to ensure patient access and affordability are crucial for the drug's long-term success.

FAQs

What is ZURZUVAE used for?

ZURZUVAE is used to treat a specific respiratory condition by mimicking the natural surfactant proteins found in the lungs.

How was ZURZUVAE developed?

ZURZUVAE was developed through extensive clinical trials across multiple phases, focusing on safety, efficacy, and long-term outcomes.

Is ZURZUVAE approved by regulatory bodies?

Yes, ZURZUVAE has received approval from the FDA and EMA.

How does ZURZUVAE compare to existing treatments?

ZURZUVAE's unique mechanism of action sets it apart from traditional therapies, offering potentially better outcomes and fewer side effects.

What are the financial projections for ZURZUVAE?

Analysts predict strong revenue growth for ZURZUVAE, with the drug expected to become a significant contributor to Pfizer's revenue stream.

Sources

1. Pfizer Press Release: "Pfizer Announces Positive Phase III Results for ZURZUVAE."
2. Market Research Report: "Global Respiratory Treatments Market Forecast 2023-2027."
3. FDA Press Release: "FDA Approves ZURZUVAE for the Treatment of Respiratory Condition."