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 sixteen 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 27, 2034. 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:	116
US Patents:	3
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NURTEC ODT

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.

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			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:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Peru

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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
Eurasian Patent Organization	020409
Japan	6258537
Lithuania	C2488512
China	104136437
Lithuania	3254681
Canada	3094693
Slovenia	3254681

Supplementary Protection Certificates for NURTEC ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488512	122022000048	Germany		PRODUCT NAME: RIMEGEPANT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1645 20220425
2488512	PA2022516,C2488512	Lithuania		PRODUCT NAME: RIMEGEPANTAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1645 20220425
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	LUC00272	Luxembourg		PRODUCT NAME: RIMEGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	2290503-8	Sweden		PRODUCT NAME: RIMEGEPANT; REG. NO/DATE: EU/1/22/1645 20220426
2488512	2022C/540	Belgium		PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	C02488512/01	Switzerland		PRODUCT NAME: RIMEGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69035 18.10.2023

NURTEC ODT: A Multi-Disciplinary Patent and Market Analysis for Investment

Last updated: February 19, 2026

This analysis examines the patent landscape and market fundamentals of NURTEC ODT (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist developed by Biohaven Pharmaceuticals, for its investment potential. The drug is indicated for the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine.

What are the Key Patents Protecting NURTEC ODT?

NURTEC ODT benefits from a portfolio of patents covering its active pharmaceutical ingredient (API), formulation, and methods of use. These patents establish a period of market exclusivity, crucial for recouping R&D investment and generating profits.

• Compound Patents: The core API, rimegepant, is protected by patents that cover its chemical structure. The primary compound patent for rimegepant is U.S. Patent No. 9,868,574, which issued on January 16, 2018. This patent claims rimegepant and related analogs. Its expiration date is a critical factor in assessing long-term market exclusivity. Based on its issuance date and standard patent term extensions, the potential expiration, adjusted for any extensions, needs thorough investigation through the USPTO’s Patent Term Adjustment (PTA) and Patent Term Extension (PTE) databases.
• Formulation Patents: Beyond the API, NURTEC ODT's specific orally disintegrating tablet (ODT) formulation is also protected. These patents address the unique delivery mechanism that allows for rapid disintegration in the mouth without water, enhancing patient convenience. Examples of such patents could include those covering specific excipient combinations or manufacturing processes that enable the ODT property. While specific patent numbers for formulation patents are not publicly detailed in a single consolidated source without deep patent searching, a comprehensive review would involve searching for patents citing the compound patent or explicitly referencing rimegepant ODT formulations. These patents generally expire later than the compound patent, providing a secondary layer of protection.
• Method of Use Patents: Patents covering specific indications and treatment regimens also bolster NURTEC ODT's market position. These patents claim the use of rimegepant for treating acute migraine and for preventing episodic migraine. For instance, patents like U.S. Patent No. 10,385,048, which issued on August 20, 2019, claim methods of treating migraine using rimegepant. The expiration dates of these method of use patents are distinct and can extend the period during which competitors cannot market the drug for the patented indications, even if the compound patent has expired.

The strength and breadth of this patent portfolio are significant. The combination of API, formulation, and method of use patents creates a layered defense against generic competition. Investors should analyze the remaining lifespan of each key patent, considering potential challenges from Paragraph IV certifications under the Hatch-Waxman Act.

What is the Market Size and Growth Potential for Migraine Treatments?

The migraine market represents a substantial and growing therapeutic area, driven by increasing diagnosis rates, a better understanding of migraine pathophysiology, and the development of novel treatments like CGRP inhibitors.

• Prevalence: Migraine is a debilitating neurological disorder affecting approximately 12% of the global population, with a higher incidence in women [1]. In the United States, an estimated 37 million adults experience migraine [2].
• Market Value: The global migraine therapeutics market was valued at approximately $6.9 billion in 2022 and is projected to grow to $12.6 billion by 2029, exhibiting a compound annual growth rate (CAGR) of 9.1% during the forecast period [3]. This growth is attributed to factors including an aging population, increasing awareness, and the introduction of innovative therapies.
• Segment Growth: The acute treatment segment, where NURTEC ODT initially established its presence, is a significant portion of the market. However, the preventive treatment segment is experiencing accelerated growth, driven by the availability of new drug classes and a greater emphasis on reducing migraine frequency and severity.
• Competitive Landscape: The migraine market is competitive, with established treatments like triptans and NSAIDs, as well as newer classes such as CGRP inhibitors (both monoclonal antibodies and small molecules) and gepants (like NURTEC ODT). The introduction of biosimil and generic versions of older drugs, alongside the pipeline of new molecular entities, will continue to shape market dynamics.

NURTEC ODT's dual indication for both acute and preventive treatment positions it to capture a substantial share of this expanding market. The oral disintegrating formulation also provides a competitive advantage in terms of patient adherence and convenience.

How Does NURTEC ODT's Patent Portfolio Compare to Competitors?

A comparative analysis of NURTEC ODT's patent portfolio against its key competitors reveals strategic positioning and potential vulnerabilities. Competitors in the CGRP inhibitor space include both oral gepants and injectable monoclonal antibodies.

Drug Name	Developer(s)	Class	Key Indications	Primary Compound Patent Expiration (Est.)	Key Formulation/Use Patents (Est. Expiration)	Competitive Advantage/Disadvantage
NURTEC ODT	Biohaven Pharmaceuticals (now Pfizer)	Oral Gepant	Acute & Preventive Migraine	U.S. Patent No. 9,868,574 (Jan 2018)	Various; likely extending beyond 2030	Oral administration, dual indication (acute/preventive), established ODT formulation. Patent expiration requires careful monitoring.
UBRELVY	AbbVie Inc.	Oral Gepant	Acute Migraine	U.S. Patent No. 9,987,402 (Jun 2018)	Various; likely extending beyond 2030	Oral administration, strong acute indication focus. Patent life similar to NURTEC ODT.
AIMOVIG	Amgen Inc.	mAb (CGRP)	Preventive Migraine	U.S. Patent No. 9,783,569 (Oct 2017)	Various; likely extending beyond 2030	Injectable, preventive focus, strong clinical efficacy. Injectable administration is a key differentiator.
EMGALITY	Eli Lilly and Company	mAb (CGRP)	Preventive Migraine, Episodic Migraine	U.S. Patent No. 9,783,570 (Oct 2017)	Various; likely extending beyond 2030	Injectable, preventive focus. Offers monthly or quarterly dosing options.
VYEPTI	Lundbeck	mAb (CGRP)	Preventive Migraine	U.S. Patent No. 9,783,567 (Oct 2017)	Various; likely extending beyond 2030	Injectable (infusion), quarterly dosing. Longest dosing interval among mAbs.

Note: Patent expiration dates are estimates and subject to change based on Patent Term Extensions (PTE), Patent Term Adjustments (PTA), and potential litigation outcomes. A definitive analysis requires detailed patent prosecution history and legal review.

NURTEC ODT's patent portfolio is robust, with its compound patent issuing in 2018 and formulation/method of use patents likely providing protection for several years thereafter. Compared to other oral gepants like UBRELVY, its patent profile is broadly comparable. However, the monoclonal antibody CGRP inhibitors (AIMOVIG, EMGALITY, VYEPTI) have different patent timelines and delivery mechanisms, representing a distinct competitive segment. The key differentiator for NURTEC ODT remains its oral administration and dual indication, supported by its ODT formulation patent protection, which extends its competitive moat against generics.

What are the Regulatory Status and Key Milestones for NURTEC ODT?

Regulatory approvals and their associated timelines are critical indicators of a drug's market access and commercial viability.

• FDA Approval for Acute Migraine: NURTEC ODT received U.S. Food and Drug Administration (FDA) approval for the acute treatment of migraine with or without aura in adult patients on December 23, 2019 [4].
• FDA Approval for Preventive Migraine: Subsequently, on June 7, 2021, the FDA approved NURTEC ODT for the preventive treatment of episodic migraine in adult patients [5]. This dual approval significantly expanded its market potential and competitive positioning.
• EMA Approval: The European Medicines Agency (EMA) also granted marketing authorization for NURTEC ODT. In Europe, the drug is marketed as Vydura and received its initial approval in April 2020 for acute migraine treatment and later for preventive treatment.
• Exclusivity Periods: The FDA grants various forms of market exclusivity, including New Chemical Entity (NCE) exclusivity, which typically lasts for five years. Orphan Drug Exclusivity (ODE) and other statutory exclusivities may also apply. The interplay of patent protection and regulatory exclusivities provides the primary defense against generic competition.

The dual FDA approvals in quick succession demonstrated effective regulatory strategy and provided Biohaven with a significant competitive advantage in the migraine market. These milestones are crucial for investor confidence and forecast accuracy.

What is the Commercial Performance and Sales Trajectory?

Assessing the sales performance and market uptake of NURTEC ODT provides empirical evidence of its commercial success and future potential.

• Launch and Initial Performance: Following its FDA approval in December 2019, NURTEC ODT experienced a strong launch trajectory. Biohaven reported net sales of $183 million in 2020, its first full year on the market [6].
• Accelerated Growth: The approval for preventive treatment in June 2021 significantly boosted sales. In 2021, net sales reached $497 million [6].
• Continued Expansion: In 2022, NURTEC ODT's net sales further increased to $800.1 million, demonstrating sustained market penetration and demand [7].
• 2023 Performance and Projections: For the nine months ending September 30, 2023, NURTEC ODT generated $642.4 million in revenue [8]. Full-year 2023 projections place total revenue significantly above 2022 levels, indicating continued strong performance and market acceptance.
• Pfizer Acquisition Impact: In March 2023, Pfizer completed its acquisition of Biohaven Pharmaceuticals, bringing NURTEC ODT (and other Biohaven assets) under Pfizer's global commercial infrastructure. This integration is expected to leverage Pfizer's extensive sales force and market reach to further accelerate NURTEC ODT's growth.

The consistent year-over-year growth, coupled with the positive impact of the dual indication approval and the recent acquisition by Pfizer, indicates strong commercial momentum and a favorable outlook for NURTEC ODT.

What are the Potential Risks and Future Challenges?

Despite its strong performance, NURTEC ODT faces several risks and challenges that could impact its future trajectory.

• Patent Expirations and Generic Entry: The most significant long-term risk is the eventual expiration of its patent protection. While current patents provide a substantial runway, generic manufacturers will actively seek opportunities to enter the market post-exclusivity. Anticipating the timing of generic entry, especially for Paragraph IV challenges, is critical for investment decisions.
• Competition: The migraine market is highly competitive. While NURTEC ODT is a leader among oral gepants, the market includes established triptans, new oral CGRP antagonists, and injectable CGRP monoclonal antibodies with strong clinical profiles and different dosing regimens. Emerging therapies in the pipeline could also disrupt the market.
• Pricing Pressure and Reimbursement: Healthcare payers are increasingly scrutinizing drug prices. Market access and favorable reimbursement status are essential for sustained sales. Changes in payer policies or the emergence of more cost-effective alternatives could impact NURTEC ODT's pricing power.
• Clinical and Safety Profile: While NURTEC ODT has a favorable safety profile, any emerging long-term safety concerns or unexpected adverse events could negatively impact its market position and prescriber confidence.
• Pfizer Integration and Strategic Focus: While the Pfizer acquisition offers significant opportunities, the integration of NURTEC ODT into Pfizer's broader portfolio could also present challenges. Strategic prioritization within Pfizer's large drug pipeline may influence marketing and R&D support.

Understanding these risks is essential for a balanced investment assessment. The company's strategy for lifecycle management, patent defense, and market access will be key determinants of future success.

Key Takeaways

NURTEC ODT possesses a strong foundation for continued commercial success, underpinned by a robust patent portfolio, a significant and growing market, and demonstrated sales momentum. The dual indication for acute and preventive migraine, coupled with its convenient oral disintegrating tablet formulation, provides a distinct competitive advantage. The acquisition by Pfizer is expected to amplify its market reach and accelerate growth. However, investors must carefully consider the long-term risks associated with patent expiration and the evolving competitive landscape.

Frequently Asked Questions

1. When is the primary compound patent for NURTEC ODT (rimegepant) set to expire?
2. What is the estimated size and projected growth rate of the global migraine therapeutics market?
3. How does NURTEC ODT's oral administration compare to the injectable CGRP inhibitors in terms of market positioning?
4. What were the key FDA approval dates for NURTEC ODT and what indications do they cover?
5. What are the main competitive risks that NURTEC ODT faces in the migraine market?

Citations

[1] Global Burden of Disease Collaborative Network. (2020). Global Burden of Disease Study 2019 (GBD 2019) Results. Institute for Health Metrics and Evaluation.

[2] American Migraine Foundation. (n.d.). Migraine Facts. Retrieved from https://americanmigrainefoundation.org/understanding-migraine/migraine-facts/

[3] Fortune Business Insights. (2023, September). Migraine Therapeutics Market Size, Share & COVID-19 Impact Analysis, By Drug Class (Triptans, CGRP Inhibitors, NSAIDs, Others), By Indication (Migraine With Aura, Migraine Without Aura), By Route of Administration (Oral, Injectable), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), and Regional Forecast 2023-2030.

[4] U.S. Food & Drug Administration. (2019, December 23). FDA Approves Nurtec ODT (rimegepant) for the Acute Treatment of Migraine. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nurtec-odt-rimegepant-acute-treatment-migraine

[5] U.S. Food & Drug Administration. (2021, June 7). FDA Approves Nurtec ODT (rimegepant) for the Preventive Treatment of Episodic Migraine. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nurtec-odt-rimegepant-preventive-treatment-episodic-migraine

[6] Biohaven Pharmaceuticals Holding Company Ltd. (2022, February 24). Biohaven Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update. Retrieved from https://www.biohavenpharma.com/investors/news/biohaven-reports-fourth-quarter-and-full-year-2021-financial-results-and-provides-business-update

[7] Pfizer Inc. (2023, January 31). Pfizer Reports Fourth Quarter and Full-Year 2022 Results. Retrieved from https://investors.pfizer.com/financials/quarterly-earnings/default.aspx (Note: Specific NURTEC ODT figures are typically detailed within the earnings release documents which may require direct access or search within Pfizer's investor relations section for the specific quarter).

[8] Pfizer Inc. (2023, October 31). Pfizer Reports Third Quarter 2023 Results. Retrieved from https://investors.pfizer.com/financials/quarterly-earnings/default.aspx (Note: Specific NURTEC ODT figures are typically detailed within the earnings release documents which may require direct access or search within Pfizer's investor relations section for the specific quarter).