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 are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zavegepant hydrochloride has seventy-one patent family members in thirty-five countries.

Two suppliers are listed for this compound.

Summary for zavegepant hydrochloride

International Patents:	71
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	9
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
Pfizer	Phase 3
Pfizer	Phase 1
Biohaven Pharmaceuticals, Inc.	Phase 1

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

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			Y	Y
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
European Patent Office	1539766	ANTAGONISTES DES RECEPTEURS DU PEPTIDE RELIE AU GENE DE LA CALCITONINE (CALCITONIN GENE RELATED PEPTIDE RECEPTOR ANTAGONISTS)
Hungary	E032132
Serbia	104004	ANTAGONISTI, PEPTIDNOG RECEPTORA KOJI JE U VEZI SA KALCITONINSKIM GENOM (CALCITONIN GENE RELATED PEPTIDE RECEPTOR ANTAGONISTS)
Taiwan	I483937

Zavegepant hydrochloride Market Analysis and Financial Projection Experimental

ZAVEGEPANT HYDROCHLORIDE: Market Dynamics and Financial Trajectory

Introduction

Zavegepant hydrochloride, marketed as ZAVZPRET™, is a groundbreaking calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved for the acute treatment of migraine in adults. This article delves into the market dynamics and financial trajectory of zavegepant, highlighting its competitive advantages, potential challenges, and projected financial performance.

Approval and Regulatory Milestones

In March 2023, the U.S. Food and Drug Administration (FDA) approved ZAVZPRET™, marking a significant milestone in migraine treatment. The approval followed a successful new drug application (NDA) submitted by Biohaven Pharmaceutical Holding Company, which was later acquired by Pfizer[2][4].

Market Positioning

Zavegepant is the first and only intranasal CGRP receptor antagonist, positioning it uniquely in the migraine treatment market. It competes with oral gepants such as AbbVie’s Ubrelvy (ubrogepant) and Biohaven’s Nurtec (rimegepant). The intranasal formulation is particularly advantageous for patients experiencing migraine-related nausea and dysphagia, who may struggle with oral medications[1][2][4].

Clinical Efficacy

The Phase 3 clinical trials demonstrated that zavegepant is statistically superior to placebo in achieving pain freedom and freedom from the most bothersome symptom at two hours post-dose. Notably, zavegepant provided pain relief as early as 15 minutes and sustained efficacy up to 48 hours in many patients[2][4].

Safety Profile

Zavegepant has shown a favorable safety profile, with no significant hepatotoxicity or elevation of liver enzymes, a concern that has plagued earlier CGRP inhibitors. Common adverse events include taste disorder, nasal discomfort, nausea, vomiting, throat irritation, nasal congestion, and fatigue/somnolence[3][5].

Competitive Landscape

The migraine treatment market is crowded with several CGRP antagonists, including Aimovig (erenumab), Emgality (galcanezumab), Ajovy (fremanezumab), and Qulipta (atogepant). However, zavegepant’s intranasal delivery method offers a distinct advantage, especially for patients who cannot tolerate oral medications due to nausea and dysphagia[4].

Financial Projections

GlobalData forecasts that zavegepant nasal spray will generate annual sales of $206.8 million in the U.S. by 2030. This projection is based on the drug’s unique delivery method and its potential to capture a significant share of the migraine treatment market[1][4].

Challenges and Considerations

Despite its promising outlook, zavegepant faces several challenges. Key opinion leaders (KOLs) have expressed concerns about side effects inherent to nasal sprays, such as congestion, post-nasal drip, and a bad taste. Additionally, there are concerns about reimbursement issues due to the higher annual costs of nasal sprays compared to oral tablets[1][4].

Marketing and Market Access Strategies

To overcome these challenges, solid marketing and market access strategies are crucial. Pfizer, with its extensive resources and experience, is well-positioned to promote zavegepant and negotiate favorable reimbursement terms. The company’s commitment to building its migraine franchise will be essential in ensuring the commercial success of zavegepant[2].

Acquisition and Collaboration

The acquisition of Biohaven’s CGRP program by Pfizer for $12.2 billion underscores the significant potential of zavegepant. This acquisition will support the development and commercialization of zavegepant, as well as other CGRP-targeting assets in Biohaven’s portfolio[1].

Future Development

In addition to its acute treatment indication, an oral formulation of zavegepant is in Phase II/III development for migraine prevention. Ongoing research also explores the use of zavegepant in other respiratory diseases, further expanding its potential therapeutic applications[1][3].

Patient Impact

The approval of zavegepant marks a significant breakthrough for migraine patients, offering a convenient and effective treatment option that can enhance their quality of life. As Angela Hwang, Chief Commercial Officer at Pfizer, noted, "ZAVZPRET underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives."[2]

Key Takeaways

• First and Only Intranasal CGRP Antagonist: Zavegepant is the first and only intranasal CGRP receptor antagonist approved for acute migraine treatment.
• Unique Delivery Method: The intranasal formulation provides a competitive edge, especially for patients with migraine-related nausea and dysphagia.
• Favorable Safety Profile: Zavegepant has shown no significant hepatotoxicity and a favorable adverse event profile.
• Financial Projections: Projected annual sales of $206.8 million in the U.S. by 2030.
• Challenges: Side effects inherent to nasal sprays and reimbursement issues.
• Marketing and Access Strategies: Solid marketing and market access strategies are crucial for commercial success.

FAQs

Q: What is zavegepant, and how is it administered?

A: Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist administered via an intranasal spray for the acute treatment of migraine in adults.

Q: What are the key benefits of zavegepant over other CGRP antagonists?

A: Zavegepant offers a unique intranasal delivery method, which is beneficial for patients experiencing nausea and dysphagia, and it has a favorable safety profile with no significant hepatotoxicity.

Q: What are the common adverse events associated with zavegepant?

A: Common adverse events include taste disorder, nasal discomfort, nausea, vomiting, throat irritation, nasal congestion, and fatigue/somnolence.

Q: Who acquired the rights to commercialize zavegepant?

A: Pfizer acquired the rights to commercialize zavegepant through its acquisition of Biohaven Pharmaceutical Holding Company.

Q: What are the projected annual sales of zavegepant by 2030?

A: GlobalData forecasts that zavegepant will generate annual sales of $206.8 million in the U.S. by 2030.

References

1. Clinical Trials Arena: Biohaven's zavegepant nasal spray set to reach projected worth of $206.8m in 2030.
2. Pfizer: Pfizer's ZAVZPRET™ (zavegepant) Migraine Nasal Spray Receives FDA Approval.
3. IJPS Journal: Zavegepant: Revolution To Migraine Therapy.
4. Drug Discovery Trends: Phase 3 study shows zavegepant can relieve migraine pain quickly.
5. FDA: 216386Orig1s000 - accessdata.fda.gov.