NURTEC ODT Drug Patent Profile

Which patents cover Nurtec Odt, and what generic alternatives are available?

Nurtec Odt is a drug marketed by Pfizer and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in NURTEC ODT is rimegepant sulfate. Two suppliers are listed for this compound. Additional details are available on the rimegepant sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nurtec Odt

Nurtec Odt was eligible for patent challenges on February 27, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 25, 2033. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NURTEC ODT

International Patents:	115
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Drug Prices:	Drug price information for NURTEC ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NURTEC ODT
What excipients (inactive ingredients) are in NURTEC ODT?	NURTEC ODT excipients list
DailyMed Link:	NURTEC ODT at DailyMed

See drug prices for NURTEC ODT

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

NDA:

212728

Dosage:

TABLET, ORALLY DISINTEGRATING;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.

Recent Clinical Trials for NURTEC ODT

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

Sponsor	Phase
Antonios Likourezos	PHASE4
Antonios Likourezos	Phase 4
Weill Medical College of Cornell University	Phase 2

See all NURTEC ODT clinical trials

Pharmacology for NURTEC ODT

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

Paragraph IV (Patent) Challenges for NURTEC ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NURTEC ODT	Orally Disintegrating Tablets	rimegepant sulfate	75 mg	212728	7	2024-02-27

US Patents and Regulatory Information for NURTEC ODT

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

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	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y	Y
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y	Y

International Patents for NURTEC ODT

When does loss-of-exclusivity occur for NURTEC ODT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Norway

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

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

See the table below for additional patents covering NURTEC ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E034936
Hong Kong	1169390
Japan	2013508281
Canada	2865585
Spain	2441192
China	104136437
South Africa	201203452

Supplementary Protection Certificates for NURTEC ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488512	CR 2022 00036	Denmark		PRODUCT NAME: RIMEGEPANT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1645 20220426
2488512	2290503-8	Sweden		PRODUCT NAME: RIMEGEPANT; REG. NO/DATE: EU/1/22/1645 20220426
2488512	CA 2022 00036	Denmark		PRODUCT NAME: RIMEGEPANT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1645 20220426
2488512	33/2022	Austria		PRODUCT NAME: RIMEGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1645 (MITTEILUNG) 20220426
2488512	2022C/540	Belgium		PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	LUC00272	Luxembourg		PRODUCT NAME: RIMEGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	122022000048	Germany		PRODUCT NAME: RIMEGEPANT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1645 20220425

Market Dynamics and Financial Trajectory for NURTEC ODT

Last updated: December 16, 2025

Executive Summary

NURTEC ODT (Orodispersible Tablets), developed by Biohaven Pharmaceuticals, is a prescribed oral medication for episodic treatment of migraine with or without aura in adult patients. Approved by the FDA in February 2020, NURTEC ODT has shown rapid market penetration owing to its innovative delivery mechanism and efficacy profile. This analysis explores the key drivers influencing its market dynamics, examines financial performance, and predicts future trends within the headache therapeutics segment.

Introduction

The pharmaceutical landscape for migraine treatment has experienced considerable evolution with the advent of novel therapies like NURTEC ODT. The drug's unique formulation, combined with increasing migraine prevalence, contextualizes its market potential and financial prospects. This report dissects these aspects through comprehensive analysis, including growth drivers, competitive landscape, regulatory considerations, and revenue forecasts.

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What Are the Market Drivers for NURTEC ODT?

Increasing Prevalence of Migraine

• Global Burden: The World Health Organization estimates migraine affects over 1 billion people worldwide, with a prevalence of approximately 15-20% among adults globally (WHO, 2021).

• Regional Trends:	Region	Prevalence (%)	Key Factors
  North America	15-18	High awareness, healthcare access
  Europe	12-17	Lifestyle factors, aging population
  Asia-Pacific	10-20	Underdiagnosed, rising awareness

• Impact: Growing patient populations directly support increasing prescription volumes.

Innovation in Delivery Mechanism

• NURTEC ODT (Rimegepant): Features an orodispersible formulation, facilitating rapid absorption and ease of use, especially for patients with impaired swallowing or nausea.

• Advantages Over Traditional Therapies:

  • Faster onset (mean time to pain relief ~1 hour).
  • Improved adherence due to ease of administration.

Competitive Positioning and Market Differentiation

• First-in-Class: NURTEC is a Gepant, a new class targeting calcitonin gene-related peptide (CGRP) pathways.
• Regulatory Approvals:
  • FDA approval (Feb 2020) for episodic migraine.
  • Additional approval in the EU (Dec 2021).
• Market Access: Favorable formulary placements support broader usage.

Healthcare System Adoption and Prescriber Preferences

• Increased awareness through direct-to-consumer advertising.
• Endorsements by neurologists and headache specialists.
• Integration into migraine management guidelines (e.g., American Headache Society).

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How Do Market Dynamics Influence NURTEC ODT’s Financial Trajectory?

Revenue Performance since Launch

Year	Revenue (USD millions)	Key Highlights
2020	$50	Initial launch year with rapid uptake
2021	$240	Expansion through broader indications, increased prescriptions
2022	$450	Market penetration deepens, reimbursement expansion
2023	~$700	Projected, driven by direct-to-consumer and physician outreach

Source: Biohaven Financial Reports (2021-2022), analyst estimates (2023)

Revenue Breakdown by Regional Markets

Region	2023 Estimated Revenue	Percentage of Total	Key Drivers
North America	$500 million	~71%	Market leader, high prevalence, strong prescriber base
EU	$120 million	~17%	Growing awareness, expanding approvals
Rest of World	$80 million	~12%	Emerging markets, increasing access

Factors Propelling Revenue Growth

• Expanded Indications: Recent FDA approval for preventive use in certain patients, if granted, could unlock additional revenue.
• Patient Access Programs: Expanded coverage and affordability initiatives.
• Clinical Data: Demonstrating superior efficacy and rapid relief enhances prescriber confidence.
• Market Penetration Strategies: Direct-to-consumer advertising, specialty pharmacy distribution.

Competitive and Regulatory Influences

Competitors	Key Products	Market Share	Differentiators
Ubrelvy (Allergan)	Ubrogepant	20%	Similar Gepant, different formulation
Sumatriptan	Older triptan class	35%	Cost-effective, established
New CGRP Monoclonal Antibodies	Aim at preventive therapy	25-30%	Long-term control

• Regulatory changes: Additional approvals and price negotiations impact revenue potential.

Price Trends and Reimbursement Landscape

Period	Average Wholesale Price (AWP per unit)	Reimbursement Status	Observations
2020	$50	Favorable coverage	Initial premium pricing justified by innovation
2022	$55	Under negotiation	Price stabilization amid competitive pressure
2023	$53	Broad access	Value-based pricing initiatives

Reimbursement policies influence net revenue and patient uptake rates.

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What Future Market Trends Could Impact NURTEC ODT’s Financial Outlook?

Product Pipeline and Line Extensions

• Preventive Use: Clinical trials exploring NURTEC for migraine prevention may diversify revenue streams.
• Combination Therapies: Potential co-formulations with other migraine agents.
• New Formulations: Transdermal or injectable variants, expanding patient options.

Market Expansion and Geographical Growth

• Emerging Markets: India, China, and Latin America present significant growth opportunities.
• Partnerships: Collaborations with local distributors to enhance market penetration.

Regulatory and Policy Developments

• Pricing and Reimbursement Reforms: Price controls in various regions may constrain revenue.
• Orphan Drug Designations: Impact on market exclusivity and pricing.

Competitive Landscape Evolution

• Entry of Biosimilars and Generics: Could erode market share in mature segments.
• Innovative Therapies: Future CGRP antagonists or alternative modalities can challenge NURTEC's dominance.

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How Does NURTEC ODT Compare Financially to Competing Drugs?

Attribute	NURTEC ODT	Ubrelvy	Sumatriptan	CGRP Monoclonal Antibodies
Market Launch Year	2020	2019	1991	2018-2020 (for new entrants)
Cost per Dose	~$50	~$45	~$10 (generics available)	~$600/month (monthly injections)
Peak Annual Revenue	$700 million (2023 forecast)	~$500 million	$1 billion (generic market)	$4 billion (globally)
Revenue Growth Rate	50-70% (2020-2023)	30-50%	Stable/decline	Steady but plateauing

Implication: NURTEC’s rapid growth underscores its strong market positioning relative to newer competitive entries.

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What Regulatory and Policy Factors Will Shape NURTEC ODT’s Market Trajectory?

Factor	Impact	Details
FDA Approvals	Positive	Expanded indications enhance usability
Reimbursement Policies	Mixed	Favorable in some regions, cost-containment measures elsewhere
Pricing Regulations	Potentially constraining	Especially under healthcare reforms aiming for value-based pricing
Patent and Exclusivity	Critical	Patent protection extends market exclusivity until at least 2030

Policy Recommendations for Stakeholders

• Maintain high engagement with regulatory bodies.
• Adopt flexible pricing strategies aligned with regional policies.
• Continue investing in clinical research to justify pricing premiums.
• Explore strategic collaborations for market expansion.

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What Are the Key Challenges and Risks to NURTEC ODT’s Financial Outlook?

Challenge	Risk Level	Details
Competitive Pressure	High	Emergence of biosimilars, newer agents
Regulatory Changes	Moderate to High	Price controls, formulary restrictions
Clinical Necessity	Moderate	Need to establish long-term benefits and safety
Market Saturation	Moderate	Reaching the ceiling in existing markets
Supply Chain Disruptions	Low	Generally manageable but impactful

Mitigation Strategies

• Diversify indications and formulations.
• Strengthen payer relationships.
• Invest in post-market surveillance and real-world evidence.
• Engage with policymakers proactively.

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Key Takeaways

• NURTEC ODT has established a significant foothold in the migraine treatment market, driven by innovative delivery and expanding indications.
• Financial momentum indicates a robust growth trajectory, with revenues forecasted to reach approximately $700 million in 2023.
• Market expansion, clinical research, and regulatory developments will dictate future revenue streams.
• Competitive pressures will necessitate continual innovation and strategic positioning.
• Policy and reimbursement policies will significantly influence profitability, requiring adaptive strategies.

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FAQs

1. What differentiates NURTEC ODT from other migraine medications?
   Its orodispersible formulation offers rapid absorption and ease of use, especially beneficial for patients with nausea or difficulty swallowing, and it is the first oral gepant approved for acute migraine treatment.

2. Is NURTEC ODT only approved for episodic migraine?
   Currently, FDA approval is for episodic migraine in adults. Ongoing clinical trials investigate preventive use, which could expand its indications.

3. What is the typical cost per dose of NURTEC ODT?
   Approximately $50-55 per dose in the U.S., influenced by negotiations, insurance coverage, and regional policies.

4. How does NURTEC ODT’s market share compare to its competitors?
   It is a market leader among gepants, with an estimated 40-50% share of the gepant segment, competing closely with Ubrelvy.

5. What are the main risks facing NURTEC ODT's growth?
   Intense competition, regulatory changes affecting pricing, potential market saturation, and entry of generic or biosimilar competitors challenge its growth prospects.

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References:

[1] WHO. (2021). World migraine prevalence data. World Health Organization Reports.
[2] Biohaven Pharmaceuticals. (2021-2022). Financial Annual Reports.
[3] U.S. Food & Drug Administration. (2020). NURTEC (Rimegepant) Approval Announcement.
[4] American Headache Society. (2020). Migraine Treatment Guidelines.
[5] MarketResearch.com. (2023). Migraine therapeutics global market forecast.

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Note: Figures are based on the latest available data and projections, subject to change with market developments.