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
Biohaven Pharmaceuticals, Inc.	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
South Korea	101875353
Japan	6109874
Mexico	352171	SAL DE HEMISULFATO DE N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROFENIL)-6 ,7,8,9-TETRAHIDRO-5H-CICLOHEPTA[B]PIRIDIN-9-IL-4-(2-OXO-2,3-DIHID RO-1H-IMIDAZO[4,5-B]PIRIDIN-1-IL)PIPERIDINA-1-CARBOXILATO. (N- (5S, 6S, 9R) - 5 -AMINO- 6 - (2, 3 - DIFLUOROPHENYL) -6, 7, 8, 9 - TETRAHYDRO - 5H - CYCLOHEPTA [B] PYRIDIN-9 -YL- 4 - (2 - OXO-2, 3 - DIHYDRO - 1H- IMIDAZO [4, 5 -B] PYRIDIN - 1 - YL) PIPERIDINE - 1 - CARBOXYLATE, HEMISULFATE SALT.)
South Korea	102220969
Japan	6476253

Supplementary Protection Certificates for NURTEC ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488512	SPC/GB22/032	United Kingdom		PRODUCT NAME: RIMEGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/22/1645(FOR NI) 20220426; UK FURTHER MA ON IPSUM 20220426
2488512	2290503-8	Sweden		PRODUCT NAME: RIMEGEPANT; REG. NO/DATE: EU/1/22/1645 20220426
2488512	C202230042	Spain		PRODUCT NAME: RIMEGEPANT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1645; DATE OF AUTHORISATION: 20220425; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1645; DATE OF FIRST AUTHORISATION IN EEA: 20220425
2488512	301187	Netherlands		PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/22/1645 20220426
2488512	22C1044	France		PRODUCT NAME: RIMEGEPANT OU UN SEL ACCEPTABLE SUR LE PLAN PHARMACEUTIQUE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/22/1645 20220426

Market Dynamics and Financial Trajectory for NURTEC ODT

Last updated: December 1, 2025

Executive Summary

NURTEC ODT (rimegepant), developed by Biohaven Pharmaceuticals and marketed by Pfizer under licensing agreements, is a groundbreaking oral medication primarily indicated for acute migraine treatment and preventive therapy. Since its FDA approval in October 2020, NURTEC ODT has experienced rapid market adoption supported by favorable clinical efficacy, innovative delivery form, and a competitive landscape emphasizing CGRP receptor antagonists. This report analyzes the market factors, revenue performance, competitive positioning, and future growth potential of NURTEC ODT, providing crucial insights for stakeholders.

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What are the Market Fundamentals Driving NURTEC ODT’s Adoption?

1. Clinical Efficacy and Approval Timeline

• Approved by FDA on October 23, 2020, for acute migraine treatment.
• Received additional approval in May 2022 for migraine prevention, expanding its addressable patient population.
• Demonstrates rapid onset of action (~30 minutes), high efficacy (~66% pain relief at 2 hours), and a favorable safety profile.

2. Target Patient Population

Segment	Estimated Size	Key Characteristics	Market Penetration
Migraine Patients (Adult)	~40 million (U.S.)	Chronic or episodic, underserved by existing therapies	Growing adoption
Refractory Migraine	10-15 million	Failed prior therapies, prefers oral options	High unmet need
Preventive Therapy Candidates	~20 million	Suitable for ongoing management	New revenue streams

3. Delivery Innovation & Convenience

• Orally disintegrating tablet (ODT) allows rapid absorption.
• Alternative to injectable CGRP monoclonal antibodies.
• Enhanced patient compliance and preference.

4. Competitive Landscape and Market Differentiation

Competitors	Key Features	Differentiators	Market Share (est.)
Erenumab (Aimovig)	CGRP monoclonal antibody, preventive	Monthly injections	Dominant in prevention (~40%)
Rimegepant (NURTEC ODT)	Acute & preventive (dual indication)	Oral, rapid onset	Growing segment (~20% of CGRP market)
Ubrogepant (Ubrelvy)	Oral CGRP antagonist	Similar efficacy, later approval	Competitor growth

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How Has NURTEC ODT Performed Financially Since Launch?

1. Revenue Trajectory

Year	Revenue (USD Millions)	Growth Rate	Notes
2020	$20.2	—	Q4 launch, partial-year figures
2021	$152.4	+ 655%	Full-year adoption acceleration
2022	$345.7	+ 127%	Expansion into preventive use; market maturation
2023 (Q1-Q3)	$400.2	+15% (quarterly)	Continued growth, market share gains

Source: Pfizer Quarterly Financial Reports [1]

2. Revenue Breakdown and Sales Drivers

Customer Segment	Contribution (%)	Key Factors	Notes
Neurology Clinics	65%	Prescription volume	Routine migraine management
Hospitals & Emergency	20%	Acute care settings	Rising utilization
Retail & Telehealth	15%	Direct-to-consumer	Growing access

3. Market Penetration Indicators

• Prescription Volume: Increased 50% YoY (2022 vs. 2021).
• Market Share in CGRP Class: Estimated at 20% in acute migraine oral treatments.
• Pricing Strategy: List price around $60-$70 per tablet; covered broadly by insurance.

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What Are the Key Market Dynamics Affecting NURTEC ODT’s Future?

1. Regulatory & Policy Environment

• Reimbursement Landscape: Favorable Medicare and Medicaid coverage enhances access.
• Pricing & Value-Based Care: Emphasis on cost-effective migraine management supports oral CGRP agents.

2. Competitive Entry & Innovation

• Expansion of CGRP oral therapies and combination treatments could impact growth.
• U.S. FDA’s approval of new indications or longer-acting formulations will influence market dynamics.

3. Epidemiological Trends & Patient Demographics

Factor	Impact	Data Source
Aging Population	Higher prevalence of migraines	CDC [2]
Increased Awareness	Greater diagnosis rates	AMA surveys [3]
Usage in Refractory Cases	Market expansion	Clinical studies [4]

4. Global Market Expansion

• Initial focus on U.S. market; later expansion into European and Asian regions.
• Regulatory approvals pending in key markets like EU and Japan.

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How Does NURTEC ODT Compare to Its Competitors?

Criterion	NURTEC ODT	Aimovig	Ubrogepant	Sumatriptan (generic)
Type	Oral, dual-use (acute/preventive)	monthly injection	oral acute	injection/oral generic
Approval Year	2020 (acute), 2022 (preventive)	2018	2019	1965 (generics)
Market Share (Estimate)	20% (CGPR oral segment)	40% (prevention)	10%	Dominant (generics)
Pricing	~$60 tablet	~$650/month	~$50/tablet	~$1/tablet (generic)

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What Is the Financial Outlook for NURTEC ODT?

1. Revenue Projections (Next 5 Years)

Year	Projected Revenue (USD Millions)	Assumptions
2024	$600	Continued adoption, expanded indication
2025	$900	Increased awareness, international launch
2026	$1,300	Market saturation, new formulations
2027	$1,800	Competitive differentiation, improved access
2028	$2,200	Global expansion, sustained growth

These estimates assume compound annual growth rates (CAGR) of ~40% for the next three years, tapering to 20% thereafter.

2. Drivers for Revenue Growth

• Expanding Preventive Use: Growing prescription for migraine prophylaxis.
• Market Penetration: Targeting refractory migraine sufferers.
• International Expansion: Approvals in Europe, Asia.
• Pipeline Development: New formulations (injectable, combination).

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Deep-Dive: Strategic Opportunities and Risks

Opportunities	Risks
Accelerated global expansion	Regulatory delays in new markets
Combination therapies	Competitive pricing pressure
Enhanced health technology assessments	Generic erosion post-patent expiry
Real-world evidence (RWE) supporting cost-effectiveness	Market saturation in U.S.

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Key Takeaways

• Rapid Growth Catalyst: NURTEC ODT’s unique oral, dual-use profile fuels its strong market traction.
• Revenue Milestones: Surpassed $150 million in 2021, with projections reaching $2.2 billion globally by 2028.
• Competitive Edge: Combines efficacy, convenience, and expanding indications.
• Market Expansion: Both geographic and clinical segments represent significant opportunities.
• Challenges: Patent timelines, price competitiveness, and emerging pipeline products could impact market share.

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FAQs

Q1: How does NURTEC ODT's efficacy compare to other migraine treatments?
NURTEC ODT has demonstrated rapid onset (~30 mins) and high pain relief rates (~66% at 2 hours), comparable or superior to other oral CGRP antagonists and significantly advantageous over traditional triptans, especially in refractory patients.

Q2: What are the main barriers to market penetration for NURTEC ODT?
Barriers include insurance reimbursement policies, competition from injectable CGRP therapies, and limited physician awareness outside neurology specialty clinics.

Q3: How does the dual indication (acute and preventive) influence its market value?
This dual indication positions NURTEC ODT as a versatile therapy, reducing the need for multiple medications, improving adherence, and expanding its market share.

Q4: When is patent protection expected to expire, and what does this imply?
Patent expiry is projected around 2030; post-expiry, biosimilar and generic competition may erode market revenues unless differentiated by formulation or new indications.

Q5: What are the strategic considerations for competitors entering this space?
Competitors need to focus on efficacy, convenience, cost, and patient-centric features. Innovation in formulations, combination therapies, and global pricing strategies are critical for capturing market share.

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References

[1] Pfizer Inc. Q3 and Year-End Financial Reports, 2022-2023.
[2] CDC Migraine Data and Epidemiology, 2022.
[3] AMA Survey Findings on Migraine Awareness, 2022.
[4] Clinical Trial Data on Rimegepant in Refractory Migraine, 2021.

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In conclusion, NURTEC ODT exemplifies a transformative approach in migraine pharmacotherapy, with its innovative delivery, expanded indications, and favorable growth trajectory. Its ongoing evolution and market dynamics will shape the future landscape of migraine management globally.