ZAVZPRET Drug Patent Profile

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

Zavzpret is a drug marketed by Pfizer and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-six patent family members in twenty-nine countries.

The generic ingredient in ZAVZPRET is zavegepant hydrochloride. Two suppliers are listed for this compound. Additional details are available on the zavegepant hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Zavzpret

Zavzpret will be eligible for patent challenges on March 9, 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 March 9, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZAVZPRET

International Patents:	36
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	1
Drug Prices:	Drug price information for ZAVZPRET
What excipients (inactive ingredients) are in ZAVZPRET?	ZAVZPRET excipients list
DailyMed Link:	ZAVZPRET at DailyMed

See drug prices for ZAVZPRET

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216386

Dosage:

SPRAY, METERED;NASAL

^*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.

Recent Clinical Trials for ZAVZPRET

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

Sponsor	Phase
Mayo Clinic	PHASE4

See all ZAVZPRET clinical trials

Pharmacology for ZAVZPRET

Drug Class	Calcitonin Gene-related Peptide Receptor Antagonist
Mechanism of Action	Calcitonin Gene-related Peptide Receptor Antagonists

US Patents and Regulatory Information for ZAVZPRET

ZAVZPRET is protected by one 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
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023		RX	Yes	Yes	8,481,546		Y	Y
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023		RX	Yes	Yes

Expired US Patents for ZAVZPRET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023	7,220,862
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023	7,314,883

International Patents for ZAVZPRET

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1539766
Brazil	112012024785
Georgia, Republic of	P20074231	CALCITONIN GENE RELATED PEPTIDE RECEPTOR ANTAGONISTS
Croatia	P20041147	CALCITONIN GENE RELATED PEPTIDE RECEPTOR ANTAGONISTS
Russian Federation	2004139061	АНТАГОНИСТЫ ПЕПТИДНОГО РЕЦЕПТОРА, СВЯЗАННОГО С ГЕНОМ КАЛЬЦИТОНИНА
Denmark	2552906

Market Dynamics and Financial Trajectory for ZAVZPRET

Last updated: August 4, 2025

Introduction

ZAVZPRET (atogepant) emerges as a promising therapeutic agent within the migraine prophylaxis landscape. Developed by Odreo (Teva Pharmaceutical Industries), ZAVZPRET is a calcitonin gene-related peptide (CGRP) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) in September 2023 for the preventive treatment of episodic migraines in adult patients. Its entry into a rapidly evolving market underscores the importance of analyzing key market dynamics and projecting its financial trajectory.

Market Overview

The global migraine therapeutics market is projected to reach approximately USD 5.2 billion by 2028, growing at a compound annual growth rate (CAGR) of around 4.5% from 2023 to 2028 [1]. The shift towards targeted biologics and small molecules, especially CGRP antagonists, catalyzes this growth. The increasing prevalence of migraine globally, coupled with heightened awareness and advancements in preventative therapies, positions ZAVZPRET to claim a significant segment within this expanding market.

Key Drivers of Market Growth

• Rising Migraine Prevalence: Approximately 1 billion individuals worldwide suffer from migraines, with about 60% classified as episodic and 40% as chronic sufferers [2]. The disorder impacts productivity and quality of life, creating sustained demand for effective prophylactic medications.

• Limitations of Existing Therapies: Traditional prophylactics, such as beta-blockers, anticonvulsants, and antidepressants, display variable efficacy and tolerability issues, driving demand for novel treatments like ZAVZPRET.

• Advancements in CGRP-based Therapies: The advent of CGRP antagonists, including erenumab, fremanezumab, and galcanezumab, has revolutionized migraine management, establishing a robust platform for follow-on agents like ZAVZPRET.

Competitive Landscape

ZAVZPRET faces competition primarily from existing CGRP monoclonal antibodies and emerging oral agents such as ubrogepant and rimegepant. While monoclonal antibodies dominate in prophylactic use due to their long half-life and efficacy, oral formulations introduce convenience and potentially broader accessibility.

Key competitors include:

• Aimovig (erenumab) – Monoclonal antibody, marketed by Amgen/Novartis.
• Emgality (galcanezumab) – Marketed by Eli Lilly.
• Vyepti (eptinezumab) – Marketed by Lundbeck.
• Nurtec ODT (rimegepant) – Oral gepant approved for both acute and preventive treatment.
• Ubrelvy (ubrogepant) – Oral gepant for acute treatment.

ZAVZPRET’s distinctive profile as a small-molecule oral CGRP receptor antagonist allows it to potentially bridge gaps in the current treatment spectrum.

Market Dynamics

Regulatory Environment

ZAVZPRET's FDA approval exemplifies strict regulatory standards and underscores the drug’s safety and efficacy profile based on pivotal clinical trials. The evolving regulatory landscape remains receptive to oral CGRP antagonists, given their convenience and targeted mechanism. Importantly, approvals in major markets like Europe and Japan are pivotal for global commercial expansion.

Prescriber and Patient Acceptance

Physicians favor oral agents for their ease of administration, especially for episodic migraine prevention. Patient preference for non-invasive, oral medications boosts adoption rates. Conversely, concerns about long-term safety profiles and potential side effects influence prescribing patterns.

Pricing and Reimbursement

Pricing strategies for ZAVZPRET will significantly impact its market penetration. Given competitive pressures, Teva must balance value-based pricing with reimbursement negotiations. In the U.S., Medicare and Medicaid, along with private insurers, heavily influence accessibility. Favorable reimbursement policies can accelerate uptake and revenue generation.

Distribution Channels

Engagement with specialty pharmacies, healthcare providers, and telemedicine platforms enhances distribution efficiency. Partnerships and direct-to-patient programs can also foster brand awareness and adherence.

Patent and Generic Landscape

Teva’s robust patent portfolio for ZAVZPRET, coupled with exclusivity periods, provides a window for premium pricing. The emergence of generics over time may exert downward price pressures, necessitating innovative value propositions and lifecycle management.

Financial Trajectory

Revenue Projections

Initial post-launch revenues depend on market size, prescriber acceptance, pricing, and competitive positioning. Early sales estimates suggest an initial launch phase capturing USD 50-100 million globally within the first year, with projections indicating potential reach of USD 500 million to USD 1 billion within 3-5 years, contingent upon market penetration and expanding indications.

Market Penetration Strategies

• Key Target Populations: Patients with episodic migraine refractory to traditional prophylactics.
• Clinical Positioning: Emphasizing oral delivery, safety profile, and efficacy to differentiate from monoclonal antibodies.
• Geographic Expansion: Sequential launches in Europe, Asia-Pacific, and other regions post-approval.

Pricing Strategy and Margins

Based on comparable products, ZAVZPRET may be priced approximately USD 600-800 per month in the U.S. with tiered pricing globally. Revenue streams will be influenced by reimbursement levels, patient affordability, and physician adoption rates.

Cost Considerations

Development costs, marketing expenditures, and manufacturing expenses shape profitability. While initial marketing investments are substantial, scale economies in manufacturing and increasing prescriptions will improve margins over time.

Long-term Outlook

As ZAVZPRET gains market share, revenue growth is expected to follow a sigmoid curve—initial slow uptake, rapid growth as awareness and trust increase, and eventual stabilization upon market saturation.

Challenges and Risks

• Competitive Pressure: Entrenched preferences for existing monoclonals pose barriers; ZAVZPRET must demonstrate clear advantages.
• Safety and Efficacy: Long-term safety data remains vital; adverse events could hinder adoption.
• Pricing Negotiations: Regulatory and payer pressures may lead to price reductions.
• Market Penetration: Physician education and patient awareness are critical; misinformation or skepticism could slow growth.

Opportunities

• Richer Patient Segments: Potential to extend indications to chronic migraine.
• Combination Therapies: Synergies with other prophylactic agents.
• Digital Health Initiatives: Integration with telemedicine and adherence tools.

Conclusion

ZAVZPRET is poised to carve out a significant role in the migraine prophylaxis market. Its success hinges on navigating competitive pressures, establishing a compelling value proposition, and deploying strategic market entry initiatives. While initial revenues may be moderate, the long-term financial trajectory appears promising, especially given the increasing global burden of migraine and patient demand for effective, convenient treatments.

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Key Takeaways

• Market Potential: The global migraine prophylaxis market is growing, driven by rising prevalence and demand for targeted therapies; ZAVZPRET aligns well with this trend.
• Competitive Edge: Oral administration offers a unique differentiation among CGRP antagonists, facilitating prescriber and patient acceptance.
• Revenue Outlook: Early sales are modest but poised for exponential growth as market penetration deepens and indications expand.
• Pricing and Reimbursement: Strategic pricing and favorable reimbursement are pivotal to maximizing revenue streams.
• Risk Mitigation: Long-term safety data and effective marketing are crucial for sustained market share.

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FAQs

1. How does ZAVZPRET differentiate itself from existing migraine prophylactics?
ZAVZPRET's oral small-molecule design offers a convenient alternative to injectable monoclonal antibodies, potentially improving adherence and broadening access.

2. What is the anticipated timeline for ZAVZPRET's geographical expansion?
Pending approval, European and Asian launches are expected within 1-2 years, contingent upon regulatory processes. Broader global expansion will follow.

3. How might pricing strategies influence ZAVZPRET’s market adoption?
Competitive, value-based pricing aligned with insurance reimbursement will be critical for physician prescribing behavior and patient affordability.

4. What are the key challenges ZAVZPRET faces in capturing market share?
Entrenched preferences for existing therapies, long-term safety concerns, and reimbursement hurdles present significant challenges.

5. Can ZAVZPRET be used for chronic migraine prevention?
Currently approved for episodic migraine, future clinical trials may explore additional indications, potentially expanding its market scope.