Zavegepant hydrochloride - Generic Drug Details

What are the generic sources for zavegepant hydrochloride and what is the scope of patent protection?

Zavegepant hydrochloride is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Zavegepant hydrochloride has thirty-six patent family members in twenty-nine countries.

Two suppliers are listed for this compound.

Summary for zavegepant hydrochloride

International Patents:	36
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	13
DailyMed Link:	zavegepant hydrochloride at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 zavegepant hydrochloride

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

Sponsor	Phase
Icahn School of Medicine at Mount Sinai	PHASE4
Pfizer	PHASE4
Pfizer	PHASE1

See all zavegepant hydrochloride clinical trials

Pharmacology for zavegepant hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for zavegepant hydrochloride

N02CD	Calcitonin gene-related peptide (CGRP) antagonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for zavegepant hydrochloride

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
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023		RX	Yes	Yes			Y	Y

Expired US Patents for zavegepant hydrochloride

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

International Patents for zavegepant hydrochloride

Country	Patent Number	Title	Estimated Expiration
Cyprus	1117593
Spain	2562610
Serbia	54608	ANTAGONOST CGRP RECEPTORA (CGRP RECEPTOR ANTAGONIST)

Market Dynamics and Financial Trajectory for Zavegepant Hydrochloride

Last updated: July 29, 2025

Introduction

Zavegepant hydrochloride, a novel calcitonin gene-related peptide (CGRP) antagonist, is emerging as a promising therapeutic candidate for the treatment of acute migraine. As a nasal spray formulation developed by Pfizer, Zavegepant is positioned within the expanding landscape of migraine therapeutics, targeting unmet needs for rapid relief and improved safety profiles. This analysis explores the current market landscape, anticipated growth drivers, competitive positioning, regulatory trajectory, and investment considerations relevant to Zavegepant hydrochloride.

Market Overview

The Burgeoning Migraine Market

Migraine affects approximately 15% of the global population, with over 1 billion sufferers worldwide [1]. The economic burden, including direct healthcare costs and lost productivity, exceeds $30 billion annually in the United States alone [2]. Traditional treatments, such as triptans and ergots, are often limited by contraindications, side effects, and incomplete efficacy, creating a substantial opportunity for novel therapeutics like CGRP antagonists.

The Rise of CGRP Inhibitors

Zavegepant belongs to the class of CGRP receptor antagonists or 'gepants,' designed to prevent or treat migraine attacks with fewer cardiovascular and build-up issues associated with earlier medications. The CGRP pathway has become a focal point for migraine management, with several pharmaceutical giants investing heavily in this space—notably Eli Lilly’s ubrogepant and pharma’s approval of rimegepant and atogepant for various migraine indications [3].

Current Market Dynamics

Regulatory Progress and Clinical Advancement

Since the launch of oral gepants, the pharmaceutical industry has seen accelerated development of nasal formulations like Zavegepant, aiming to provide rapid onset of relief. Pfizer's Zavegepant nasal spray has demonstrated promising phase 3 clinical trial results showing significant reduction in migraine pain within two hours, with a favorable safety profile [4]. Such development positions Zavegepant to fill its niche for urgent, non-oral migraine relief, especially beneficial for patients experiencing nausea or vomiting.

Competitive Landscape

Zavegepant faces competition from existing oral gepants, monoclonal antibodies targeting CGRP pathways, and emerging therapies such as lasmiditan. While oral formulations offer convenience, nasal delivery offers rapid onset, setting Zavegepant apart for acute management. Key competitors include:

• Ubrogepant (AbbVie): First oral gepant approved in 2019.
• Rimegepant (Biohaven): Approved for both acute and preventive treatment.
• Eptinezumab (Alder BioPharma): IV monoclonal antibody for preventive therapy.
• Lasmiditan (Eli Lilly): Non-CGRP receptor-acting drug, central nervous system active.

The nasal route provides a differentiation point amidst these therapies, potentially capturing a segment of the market seeking swift relief.

Market Entry and Adoption Challenges

Despite promising clinical data, commercialization hurdles could impact Zavegepant's trajectory, including:

• Regulatory approvals: Awaited FDA and EMA decisions are critical.
• Physician acceptance: Educating clinicians on nasal delivery advantages.
• Patient preferences: Willingness to adopt nasal sprays over oral medications.
• Pricing and reimbursement: Will significantly influence market penetration.

Financial Trajectory

Revenue Projections

With optimistic regulatory milestones, Pfizer aims for Zavegepant to tap into the multi-billion-dollar migraine market. In the initial phase, forecasts suggest:

• Year 1 post-approval: $100–$200 million in sales, capturing treatment for acute migraine episodes.
• Year 3–5: Potential to reach $500 million to over $1 billion, driven by expanded indications, formulary acceptance, and geographic expansion.

Forecasts are contingent upon successful regulatory approval, market acceptance, and competitive positioning.

R&D and Commercial Investment

Pfizer has invested substantially in clinical programs, with Phase 3 data suggesting a robust efficacy and safety profile. Marketing investment will focus on nephrologists and neurologists, as well as patient education campaigns emphasizing nasal delivery convenience.

Pricing Strategy and Reimbursement

Pricing will likely align with or slightly premium over existing gepants (approximately $50–$70 per dose), with insurance reimbursement being pivotal for adoption. NHS and Medicaid reimbursement strategies will influence accessibility in the U.S. and other major markets.

Market Risks and Revenue Risks

The trajectory remains susceptible to:

• Regulatory delays or denials
• Emergence of competitive therapies
• Safety concerns or adverse event reports post-market
• Limited patient acceptance of nasal delivery

Regulatory and Commercial Outlook

Regulatory Milestones

Approval timelines are anticipated in 2023–2024, contingent on ongoing phase 3 trial results. Regulatory agencies’ acceptance hinges on demonstrated efficacy, safety, and manufacturing quality.

Market Expansion Opportunities

Beyond the U.S., Europe, Japan, and other large markets offer significant revenue potential. Zavegepant could expand indications for preventive therapy if further trials demonstrate efficacy.

Strategic Collaborations and Licensing

Partnerships with regional distributors or licensing deals could accelerate market entry, especially in emerging markets where migraine prevalence is high but access to advanced therapies is limited.

Conclusion

Zavegepant hydrochloride’s introduction into the migraine therapeutics market represents a significant evolution in acute migraine management. Its nasal formulation, rapid onset, and favorable safety profile position it favorably against existing therapies, notably oral gepants and monoclonal antibodies. The financial trajectory depends heavily on regulatory success, market acceptance, pricing strategies, and competitive dynamics.

Preparedness in navigating these facets, coupled with strategic marketing and partnerships, is crucial for maximizing revenue potential. As migraine remains a significant global health burden, Zavegepant’s success could redefine acute treatment paradigms while delivering substantial value to Pfizer and stakeholders.

Key Takeaways

• Market Opportunity: The global migraine market exceeds $30 billion; innovations like Zavegepant fill urgent therapeutic gaps.
• Competitive Edge: Nasal delivery offers rapid relief, differentiating Zavegepant from oral gepants and injectables.
• Regulatory Pathway: Anticipated approval timelines in 2023-2024 are pivotal; positive trial results bolster prospects.
• Revenue Potential: Year 1 sales forecast at $100–$200 million, with potential growth surpassing $1 billion in favorable scenarios.
• Strategic Focus: Success hinges on regulatory approval, reimbursable pricing, clinician awareness, and patient adoption.

FAQs

1. When is Zavegepant hydrochloride expected to receive FDA approval?
Pfizer anticipates regulatory decisions in 2023–2024, pending positive phase 3 trial outcomes and review processes.

2. How does Zavegepant compare to existing migraine treatments?
Zavegepant offers rapid, non-oral relief via nasal spray, advantageous for patients with nausea or vomiting, setting it apart from oral gepants and injectable CGRP antibodies.

3. What are the main barriers to market entry for Zavegepant?
Regulatory approval, clinician acceptance, reimbursement strategies, patient preference for delivery route, and competitive pressure pose primary challenges.

4. What is the projected market size for Zavegepant?
Initial sales could reach $100–$200 million in the first year post-launch, with global potential exceeding $1 billion as adoption broadens.

5. Are there any known safety concerns associated with Zavegepant?
Clinical trials have demonstrated a favorable safety profile; ongoing surveillance post-market will monitor for adverse events.

References

[1] International Headache Society. The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018.
[2] Blumenfeld AM, et al. The Burden of Migraine: Results from the International Burden of Migraine Study (IBMS). Headache. 2019.
[3] Goadsby PJ, et al. CGRP antagonists for migraine. N Engl J Med. 2019.
[4] Pfizer Announces Positive Top-Line Results for Zavegepant Nasal Spray for Acute Treatment of Migraine. Pfizer Press Release, 2022.